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This is a randomized, double-blind, single center, phase 2 study to assess efficacy and safety of multiple allogeneic HB-adMSCs vs Placebo for the treatment of Parkinson's disease.
The trial includes a screening period of up to 4 weeks, a 32- week treatment period, and a safety Follow-up period of 20 weeks after the last investigational product administration.
This clinical trial will be open to enroll 60 eligible participants diagnosed with Parkinson's disease. Patients' recruitment will be conducted by the study team, if eligible participants are identified based on eligibility criteria, a screening visit will be scheduled. Informed consent form will be given to the study participants and signed before any study procedures. Informed consent form will include information about the clinical trial and some aspects should be considered during this process.
After Informed consent has been obtained, each participant should complete the following visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allogeneic HB-adMSCs. | Active Comparator | Biological/Vaccine: Allogeneic HB-adMSCs Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify. Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells. |
|
| Placebo | Placebo Comparator | Placebo will be administered intravenously to study participants who qualify. Other Names: Sterile Saline Solution 0.9% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological/Vaccine: Allogeneic HB-adMSCs | Biological | HB-adMSCs will be administered intravenously to study participants who qualify. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in MDS-UPDRS Part III Total Score | Clinically significant changes in MDS-UPDRS Part III. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total). Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe. The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability). Higher values represent a worse outcome. | Baseline to Weeks 52 |
| Change From Baseline in MDS-UPDRS Part III (Statistical Analysis - RMA Model) | Clinically significant changes in MDS-UPDRS Part III. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total). Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe. The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability). Higher values represent a worse outcome. | Baseline to Weeks 52 |
| Change From Baseline in MDS-UPDRS Part III (Bayesian Statistical Analysis - RMA Model) | Clinically significant changes in MDS-UPDRS Part III. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total). Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe. The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability). Higher values represent a worse outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in MDS-UPDRS Part I Total Score | The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
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Inclusion Criteria:
A study participant will be eligible for inclusion in this study only if all the following criteria apply:
Exclusion Criteria:
A study participant will not be eligible for inclusion in this clinical trial if any of the following criteria apply:
Pregnancy, lactation. Women of childbearing age who are not pregnant but do not take effective contraceptive measures.
Study participants with advanced Parkinson's disease described as, severe disability, wheelchair bound or bedridden.
Study participant has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma or melanoma.
Study participant has known alcoholic addiction or dependency or has current substance use or abuse.
Study participant has 1 or more significant concurrent medical conditions (verified by medical records), including the following:
Study participant has received any stem cell treatment within 6 months before first dose of investigational product other than stem cells produced by Hope Biosciences.
Receiving any investigational therapy or any approved therapy for investigational use within 1 year prior first dose of the investigational product other than COVID-19 vaccines.
Study participant has a laboratory abnormality during screening, including the following:
Study participant has any other laboratory abnormality or medical condition which, in the opinion of the investigator, poses a safety risk or will prevent the subject from completing the study.
Study participant is unlikely to complete the study or adhere to the study procedures.
Study participant with known concurrent acute or chronic viral hepatis B or C or human immunodeficiency virus (HIV) infection.
Study participant has a previously diagnosed psychiatric condition which in the opinion of the investigator may affect self-assessments.
Study participant with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product.
Male study participants who plan to donate sperm during the study or within 6 months after the last dose. Female patients who plan to donate eggs or undergo in vitro fertilization treatment during the study or within 6 months after the last dose.
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| Name | Affiliation | Role |
|---|---|---|
| Djamchid Lotfi, MD | Hope Biosciences Stem Cell Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Biosciences Stem Cell Research Foundation | Sugar Land | Texas | 77478 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30540129 | Background | Cuenca L, Gil-Martinez AL, Cano-Fernandez L, Sanchez-Rodrigo C, Estrada C, Fernandez-Villalba E, Herrero MT. Parkinson's disease: a short story of 200 years. Histol Histopathol. 2019 Jun;34(6):573-591. doi: 10.14670/HH-18-073. Epub 2018 Dec 12. | |
| 22229124 | Background | Goetz CG. The history of Parkinson's disease: early clinical descriptions and neurological therapies. Cold Spring Harb Perspect Med. 2011 Sep;1(1):a008862. doi: 10.1101/cshperspect.a008862. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Allogeneic HB-adMSCs. | Biological/Vaccine: Allogeneic HB-adMSCs Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify. Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells. |
| FG001 | Placebo | Placebo will be administered intravenously to study participants who qualify. Other Names: Sterile Saline Solution 0.9% |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Allogeneic HB-adMSCs. | Biological/Vaccine: Allogeneic HB-adMSCs Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify. Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in MDS-UPDRS Part III Total Score | Clinically significant changes in MDS-UPDRS Part III. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total). Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe. The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability). Higher values represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (132 points total) | Baseline to Weeks 52 |
Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Allogeneic HB-adMSCs. | Biological/Vaccine: Allogeneic HB-adMSCs Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify. Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | General disorders | Non-systematic Assessment | Chest pain |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ridhima Vij, Ph.D | Hope Biosciences Research Foundation | 346-900-0340 | 102 | ridhima@hopebio.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 19, 2022 | Apr 15, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 22, 2025 | Apr 7, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 31, 2022 | Apr 7, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D001688 | Biological Products |
| ID | Term |
|---|---|
| D045424 | Complex Mixtures |
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A parallel study is a type of clinical study where two groups of treatments, A (allogeneic HB-adMSCs) and B (Placebo), are given so that one group receives only A while another group receives only B.
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Study subjects, investigators and study staff will be blinded to the assigned treatment.
|
| Placebo | Other | Sterile Saline Solution 0.9% |
|
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| Baseline to Weeks 52 |
| Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part III Score - by Treatment Week | The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total). Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe. The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability). Higher values represent a worse outcome. | Baseline to Weeks 52 |
| Change From Baseline in MDS-UPDRS Part II Total Score | Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | Baseline to Weeks 52 |
| Changes From Baseline in MDS-UPDRS Part II (Statistical Analysis - RMA Model) | Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | Baseline to Weeks 52 |
| Change From Baseline in MDS-UPDRS Part II (Bayesian Statistical Analysis - RMA Model) | Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | Baseline to Weeks 52 |
| Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part II Score - by Treatment Week | The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | Baseline to Weeks 52 |
| Baseline to Weeks 52 |
| Change From Baseline in MDS-UPDRS Part I (Statistical Analysis - RMA Model) | The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | Baseline to Weeks 52 |
| Change From Baseline in MDS-UPDRS Part I (Bayesian Statistical Analysis - RMA Model) | The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | Baseline to Weeks 52 |
| Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part I Score - by Treatment Week | The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | Baseline to Weeks 52 |
| Change From Baseline in MDS-UPDRS Part IV Total Score | Clinically significant changes in MDS-UPDRS Part IV. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part IV tests "Motor Complications", including time spent with dyskinesias and others. There are 6 items included in Part IV. Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | Baseline to Weeks 52 |
| Change From Baseline in MDS-UPDRS Part IV Total Score (Statistical Analysis - RMA Model) | Clinically significant changes in MDS-UPDRS Part IV. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part IV tests "Motor Complications", including time spent with dyskinesias and others. There are 6 items included in Part IV. Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | Baseline to Weeks 52 |
| Change From Baseline in MDS-UPDRS Part IV Total Score (Bayesian Statistical Analysis - RMA Model) | Clinically significant changes in MDS-UPDRS Part IV. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part IV tests "Motor Complications", including time spent with dyskinesias and others. There are 6 items included in Part IV. Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | Baseline to Weeks 52 |
| Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part IV Score - by Treatment Week | The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part IV tests "Motor Complications", including time spent with dyskinesias and others. There are 6 items included in Part IV. Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 (Average General Health) Total Score | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 (Average Physical Functioning) Total Score | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 (Average Social Functioning) Total Score | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health) Total Score | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 (Average General Health) Total Score (Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 (Average Social Functioning) Total Score (Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health ) Total Score (Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score (Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 (Average General Health) Total Score (Bayesian Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Bayesian Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Bayesian Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 (Average Social Functioning) Total Score (Bayesian Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Bayesian Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Bayesian Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 (Average Role Limitations Due To Physical Health) Total Score (Bayesian Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in SF-36 (Average Role Limitations Due To Emotional Problems) Total Score (Bayesian Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | Baseline to Weeks 52 |
| Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Raw Scores | The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients. It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function. It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect. There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points). The PFS-16 score ranges from 16 (minimum) to 80 (maximum). Higher scores represent a worse outcome. | Baseline to Weeks 52 |
| Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Statistical Analysis - RMA Model) | Clinically significant changes in PFS-16 scores. The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients. It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function. It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect. There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points). The PFS-16 score ranges from 16 (minimum) to 80 (maximum). Higher scores represent a worse outcome. | Baseline to Weeks 52 |
| Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Bayesian Statistical Analysis - RMA Model) | Clinically significant changes in PFS-16 scores. The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients. It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function. It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect. There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points). The PFS-16 score ranges from 16 (minimum) to 80 (maximum). Higher scores represent a worse outcome. | Baseline to Weeks 52 |
| Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores | Clinically significant changes in PDQ-39 SI raw scores. The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month. The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being. Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always). The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100). To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100). Higher scores represent a worse outcome. | Baseline to Weeks 52 |
| Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Statistical Analysis - RMA Model) | Clinically significant changes in PDQ-39 SI raw scores. The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month. The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being. Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always). The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100). To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100). Higher scores represent a worse outcome. | Baseline to Weeks 52 |
| Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Bayesian Statistical Analysis - RMA Model) | Clinically significant changes in PDQ-39 SI raw scores. The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month. The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being. Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always). The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100). To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100). Higher scores represent a worse outcome. | Baseline to Weeks 52 |
| Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores - by Treatment Week | The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month. The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being. Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always). The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100). To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100). Higher scores represent a worse outcome. | Baseline to Weeks 52 |
| Change From Baseline in Visual Analog Scale (VAS) Pain Raw Scores | Clinically significant changes in VAS Pain raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas. The patient marks a point on the line corresponding to their pain intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes. | Baseline to Weeks 52 |
| Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Statistical Analysis - RMA Model) | Clinically significant changes in VAS Pain raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas. The patient marks a point on the line corresponding to their pain intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes. | Baseline to Weeks 52 |
| Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Bayesian Statistical Analysis - RMA Model) | Clinically significant changes in VAS Pain raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas. The patient marks a point on the line corresponding to their pain intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes. | Baseline to Weeks 52 |
| Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Raw Scores | Clinically significant changes in VAS Muscle Spasm raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas. The patient marks a point on the line corresponding to their muscle spasm intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes. | Baseline to Weeks 52 |
| Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Statistical Analysis - RMA Model) | Clinically significant changes in VAS Muscle Spasm raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas. The patient marks a point on the line corresponding to their muscle spasm intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes. | Baseline to Weeks 52 |
| Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Bayesian Statistical Analysis - RMA Model) | Clinically significant changes in VAS Muscle Spasm raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas. The patient marks a point on the line corresponding to their muscle spasm intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes. | Baseline to Weeks 52 |
| Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total VAS Scores - by Treatment Week | The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" in the Pain section and "No muscle spasm" and "worst muscle spasm" in the Muscle Spasm section, used to measure intensity in pain and various other areas. The patient marks a point on the line corresponding to their pain intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm for each section. The total score is achieved by summing the two individual scores. Higher scores represent worse outcomes. | Baseline to Weeks 52 |
| Summary of PD Medication Dose Changes by Visit | The following table depicts the count of participants that decreased, increased, or did not change their Parkinson's disease medication dosage over the course of the study at various timepoints. The safety analysis set (30 patients in Placebo, 30 patients in HB-adMSCs) was assessed at the various timepoints. | Baseline to Weeks 52 |
| Summary of PD Medication Reinstatement by Visit | The table prior to this one depicts the count of participants that decreased, increased, or did not change their Parkinson's disease medication dosage over the course of the study at various timepoints. This table depicts the count of participants that reinstated their dose of Parkinson's disease medications after decreasing it throughout the clinical trial. The safety analysis set (30 patients in Placebo, 30 patients in HB-adMSCs) was assessed at the various timepoints. | Baseline to Weeks 52 |
| Treatment Emergent Adverse Events (Subjects With >= 1 Adverse Event) - Summary - Safety Analysis Set | Unit (# of participants) - Treatment emergent Adverse events (Subjects with >= 1 adverse event) - Summary - Safety analysis set. Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24). | Baseline to Week 24 |
| Treatment Emergent Adverse Events (Serious AEs) - Summary - Safety Analysis Set | Unit (# of participants) - Treatment emergent Adverse events (Serious AEs) - Summary - Safety analysis set. Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24). | Baseline to Week 24 |
| Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52] | Unit (x10^9 cells/L) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Weeks 52 |
| Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52] | Unit (%) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Weeks 52 |
| Change From Baseline Laboratory Values - CBC (g/dL) [Time Frame: Baseline to Week 52] | Unit (g/dL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Weeks 52 |
| Change From Baseline Laboratory Values - CBC (pg) [Time Frame: Baseline to Week 52] | Unit (pg) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Weeks 52 |
| Change From Baseline Laboratory Values - CBC (fL) [Time Frame: Baseline to Week 52] | Unit (fL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Weeks 52 |
| Change From Baseline Laboratory Values - CBC (10^12/L) [Time Frame: Baseline to Week 52] | Unit (10^12/L) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Weeks 52 |
| Change From Baseline Laboratory Values - CMP (g/dL) [Time Frame: Baseline to Week 52] | Unit (g/dL) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Weeks 52 |
| Change From Baseline Laboratory Values - CMP (Ratio) [Time Frame: Baseline to Week 52] | Unit (Ratio) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Weeks 52 |
| Change From Baseline Laboratory Values - CMP (IU/L) [Time Frame: Baseline to Week 52] | Unit (IU/L) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Weeks 52 |
| Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52] | Unit (mg/dL) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Weeks 52 |
| Change From Baseline Laboratory Values - CMP (mmol/L) [Time Frame: Baseline to Week 52] | Unit (mmol/L) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Weeks 52 |
| Change From Baseline Laboratory Values - CMP (mL/Min/1.73 m^2) [Time Frame: Baseline to Week 52] | Unit (mL/min/1.73 m^2) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Weeks 52 |
| Change From Baseline Laboratory Values - Coagulation Panel (Ratio) [Time Frame: Baseline to Week 52] | Unit (Ratio) - Change From Baseline Clinical Laboratory Coagulation Panel by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Weeks 52 |
| Change From Baseline Laboratory Values - Coagulation Panel (Sec.) [Time Frame: Baseline to Week 52] | Unit (sec.) - Change From Baseline Clinical Laboratory Coagulation Panel by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Weeks 52 |
| Change From Baseline in Vital Signs (Diastolic Blood Pressure - mmHg) | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Weeks 52 |
| Change From Baseline in Vital Signs (Heart Rate - Beats/Min) | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Weeks 52 |
| Change From Baseline in Vital Signs (Oxygen Saturation - %) | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Weeks 52 |
| Change From Baseline in Vital Signs (Respiration Rate - Breaths/Min) | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Weeks 52 |
| Change From Baseline in Vital Signs (Systolic Blood Pressure - mmHg) | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Weeks 52 |
| Change From Baseline in Vital Signs (Temperature - Celsius) | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Weeks 52 |
| Change From Baseline in Vital Signs (Weight - kg) | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Weeks 52 |
| Physical Examination - by Treatment Week - Abdomen | Physical examination - by treatment week - Summary - Safety analysis set | Baseline to Weeks 52 |
| Physical Examination - by Treatment Week - Cardiovascular | Physical examination - by treatment week - Summary - Safety analysis set | Baseline to Weeks 52 |
| Physical Examination - by Treatment Week - HEENT | Physical examination - by treatment week - Summary - Safety analysis set - Head, Eyes, Ears, Nose, and Throat | Baseline to Weeks 52 |
| Physical Examination - by Treatment Week - Lymph Node | Physical examination - by treatment week - Summary - Safety analysis set | Baseline to Weeks 52 |
| Physical Examination - by Treatment Week - Musculoskeletal | Physical examination - by treatment week - Summary - Safety analysis set | Baseline to Weeks 52 |
| Physical Examination - by Treatment Week - Neurological | Physical examination - by treatment week - Summary - Safety analysis set | Baseline to Weeks 52 |
| Physical Examination - by Treatment Week - Respiratory | Physical examination - by treatment week - Summary - Safety analysis set | Baseline to Weeks 52 |
| Physical Examination - by Treatment Week - Skin | Physical examination - by treatment week - Summary - Safety analysis set | Baseline to Weeks 52 |
| 30702835 | Background | Stoker TB, Greenland JC, editors. Parkinson's Disease: Pathogenesis and Clinical Aspects [Internet]. Brisbane (AU): Codon Publications; 2018 Dec 21. Available from http://www.ncbi.nlm.nih.gov/books/NBK536721/ |
| 25904081 | Background | Kalia LV, Lang AE. Parkinson's disease. Lancet. 2015 Aug 29;386(9996):896-912. doi: 10.1016/S0140-6736(14)61393-3. Epub 2015 Apr 19. |
| 32044947 | Background | Armstrong MJ, Okun MS. Diagnosis and Treatment of Parkinson Disease: A Review. JAMA. 2020 Feb 11;323(6):548-560. doi: 10.1001/jama.2019.22360. |
| 28494719 | Background | Tambasco N, Romoli M, Calabresi P. Levodopa in Parkinson's Disease: Current Status and Future Developments. Curr Neuropharmacol. 2018;16(8):1239-1252. doi: 10.2174/1570159X15666170510143821. |
| 9358193 | Background | Marsden CD. Problems with long-term levodopa therapy for Parkinson's disease. Clin Neuropharmacol. 1994;17 Suppl 2:S32-44. |
| 31569696 | Background | Coppin L, Sokal E, Stephenne X. Thrombogenic Risk Induced by Intravascular Mesenchymal Stem Cell Therapy: Current Status and Future Perspectives. Cells. 2019 Sep 27;8(10):1160. doi: 10.3390/cells8101160. |
| 23313481 | Background | Tatsumi K, Ohashi K, Matsubara Y, Kohori A, Ohno T, Kakidachi H, Horii A, Kanegae K, Utoh R, Iwata T, Okano T. Tissue factor triggers procoagulation in transplanted mesenchymal stem cells leading to thromboembolism. Biochem Biophys Res Commun. 2013 Feb 8;431(2):203-9. doi: 10.1016/j.bbrc.2012.12.134. Epub 2013 Jan 9. |
| 31018669 | Background | Musial-Wysocka A, Kot M, Majka M. The Pros and Cons of Mesenchymal Stem Cell-Based Therapies. Cell Transplant. 2019 Jul;28(7):801-812. doi: 10.1177/0963689719837897. Epub 2019 Apr 24. |
| 30858851 | Background | Garretti F, Agalliu D, Lindestam Arlehamn CS, Sette A, Sulzer D. Autoimmunity in Parkinson's Disease: The Role of alpha-Synuclein-Specific T Cells. Front Immunol. 2019 Feb 25;10:303. doi: 10.3389/fimmu.2019.00303. eCollection 2019. |
| 19926330 | Background | Meirelles Lda S, Fontes AM, Covas DT, Caplan AI. Mechanisms involved in the therapeutic properties of mesenchymal stem cells. Cytokine Growth Factor Rev. 2009 Oct-Dec;20(5-6):419-27. doi: 10.1016/j.cytogfr.2009.10.002. Epub 2009 Nov 18. |
| 15684121 | Background | Giannini EG, Testa R, Savarino V. Liver enzyme alteration: a guide for clinicians. CMAJ. 2005 Feb 1;172(3):367-79. doi: 10.1503/cmaj.1040752. |
| 32332985 | Background | Tan EK, Chao YX, West A, Chan LL, Poewe W, Jankovic J. Parkinson disease and the immune system - associations, mechanisms and therapeutics. Nat Rev Neurol. 2020 Jun;16(6):303-318. doi: 10.1038/s41582-020-0344-4. Epub 2020 Apr 24. |
| 24027567 | Background | Dimarino AM, Caplan AI, Bonfield TL. Mesenchymal stem cells in tissue repair. Front Immunol. 2013 Sep 4;4:201. doi: 10.3389/fimmu.2013.00201. |
| 21303266 | Background | Ra JC, Shin IS, Kim SH, Kang SK, Kang BC, Lee HY, Kim YJ, Jo JY, Yoon EJ, Choi HJ, Kwon E. Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans. Stem Cells Dev. 2011 Aug;20(8):1297-308. doi: 10.1089/scd.2010.0466. Epub 2011 Mar 17. |
Placebo will be administered intravenously to study participants who qualify. Other Names: Sterile Saline Solution 0.9% |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height | Mean | Standard Deviation | centimeters |
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| Weight | Mean | Standard Deviation | kilograms |
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| BMI | Mean | Standard Deviation | kilograms/(meters*meters) |
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| Carbidopa/Levodopa Dose | Count of Participants | Participants |
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| MDS-UPDRS Part II + III Total Scores | The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool physicians use to gauge the progress of Parkinson's disease in patients. Part II tests Motor Aspects of Experiences of Daily Living and Part III tests Motor Examination skills. There are 46 total items in Part II and III. Part II score ranges from 0-52 and Part III score ranges from 0-132. Each item is scored as follows: 0(normal), 1(slight), 2(mild), 3(moderate), and 4(severe). The total score for Part II and III is from 0 to 184, with higher values representing a worse outcome. | Count of Participants | Participants |
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| Primary | Change From Baseline in MDS-UPDRS Part III (Statistical Analysis - RMA Model) | Clinically significant changes in MDS-UPDRS Part III. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total). Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe. The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability). Higher values represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Error | Score on a scale (132 points total) | Baseline to Weeks 52 |
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| Primary | Change From Baseline in MDS-UPDRS Part III (Bayesian Statistical Analysis - RMA Model) | Clinically significant changes in MDS-UPDRS Part III. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total). Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe. The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability). Higher values represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (132 points total) | Baseline to Weeks 52 |
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| Primary | Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part III Score - by Treatment Week | The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total). Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe. The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability). Higher values represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Count of Participants | Participants | Baseline to Weeks 52 |
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| Primary | Change From Baseline in MDS-UPDRS Part II Total Score | Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (52 points total) | Baseline to Weeks 52 |
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| Primary | Changes From Baseline in MDS-UPDRS Part II (Statistical Analysis - RMA Model) | Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Error | Score on a scale (52 points total) | Baseline to Weeks 52 |
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| Primary | Change From Baseline in MDS-UPDRS Part II (Bayesian Statistical Analysis - RMA Model) | Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (52 points total) | Baseline to Weeks 52 |
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| Primary | Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part II Score - by Treatment Week | The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Count of Participants | Participants | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in MDS-UPDRS Part I Total Score | The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (52 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in MDS-UPDRS Part I (Statistical Analysis - RMA Model) | The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Error | Score on a scale (52 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in MDS-UPDRS Part I (Bayesian Statistical Analysis - RMA Model) | The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (52 points total) | Baseline to Weeks 52 |
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| Secondary | Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part I Score - by Treatment Week | The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Count of Participants | Participants | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in MDS-UPDRS Part IV Total Score | Clinically significant changes in MDS-UPDRS Part IV. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part IV tests "Motor Complications", including time spent with dyskinesias and others. There are 6 items included in Part IV. Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (24 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in MDS-UPDRS Part IV Total Score (Statistical Analysis - RMA Model) | Clinically significant changes in MDS-UPDRS Part IV. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part IV tests "Motor Complications", including time spent with dyskinesias and others. There are 6 items included in Part IV. Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Error | Score on a scale (24 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in MDS-UPDRS Part IV Total Score (Bayesian Statistical Analysis - RMA Model) | Clinically significant changes in MDS-UPDRS Part IV. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part IV tests "Motor Complications", including time spent with dyskinesias and others. There are 6 items included in Part IV. Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (24 points total) | Baseline to Weeks 52 |
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| Secondary | Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part IV Score - by Treatment Week | The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part IV tests "Motor Complications", including time spent with dyskinesias and others. There are 6 items included in Part IV. Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Count of Participants | Participants | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 (Average General Health) Total Score | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 (Average Physical Functioning) Total Score | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 (Average Social Functioning) Total Score | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health) Total Score | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 (Average General Health) Total Score (Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Error | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Error | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Error | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 (Average Social Functioning) Total Score (Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Error | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Error | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Error | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health ) Total Score (Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Error | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score (Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Error | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 (Average General Health) Total Score (Bayesian Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Bayesian Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Bayesian Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 (Average Social Functioning) Total Score (Bayesian Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Bayesian Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Bayesian Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 (Average Role Limitations Due To Physical Health) Total Score (Bayesian Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in SF-36 (Average Role Limitations Due To Emotional Problems) Total Score (Bayesian Statistical Analysis - RMA Model) | The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Raw Scores | The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients. It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function. It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect. There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points). The PFS-16 score ranges from 16 (minimum) to 80 (maximum). Higher scores represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (80 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Statistical Analysis - RMA Model) | Clinically significant changes in PFS-16 scores. The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients. It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function. It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect. There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points). The PFS-16 score ranges from 16 (minimum) to 80 (maximum). Higher scores represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Error | Score on a scale (80 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Bayesian Statistical Analysis - RMA Model) | Clinically significant changes in PFS-16 scores. The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients. It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function. It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect. There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points). The PFS-16 score ranges from 16 (minimum) to 80 (maximum). Higher scores represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (80 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores | Clinically significant changes in PDQ-39 SI raw scores. The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month. The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being. Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always). The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100). To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100). Higher scores represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Statistical Analysis - RMA Model) | Clinically significant changes in PDQ-39 SI raw scores. The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month. The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being. Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always). The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100). To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100). Higher scores represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Error | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Bayesian Statistical Analysis - RMA Model) | Clinically significant changes in PDQ-39 SI raw scores. The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month. The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being. Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always). The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100). To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100). Higher scores represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (100 points total) | Baseline to Weeks 52 |
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| Secondary | Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores - by Treatment Week | The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month. The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being. Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always). The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100). To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100). Higher scores represent a worse outcome. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Count of Participants | Participants | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in Visual Analog Scale (VAS) Pain Raw Scores | Clinically significant changes in VAS Pain raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas. The patient marks a point on the line corresponding to their pain intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (10 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Statistical Analysis - RMA Model) | Clinically significant changes in VAS Pain raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas. The patient marks a point on the line corresponding to their pain intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Error | Score on a scale (10 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Bayesian Statistical Analysis - RMA Model) | Clinically significant changes in VAS Pain raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas. The patient marks a point on the line corresponding to their pain intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (10 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Raw Scores | Clinically significant changes in VAS Muscle Spasm raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas. The patient marks a point on the line corresponding to their muscle spasm intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (10 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Statistical Analysis - RMA Model) | Clinically significant changes in VAS Muscle Spasm raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas. The patient marks a point on the line corresponding to their muscle spasm intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Error | Score on a scale (10 points total) | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Bayesian Statistical Analysis - RMA Model) | Clinically significant changes in VAS Muscle Spasm raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas. The patient marks a point on the line corresponding to their muscle spasm intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Score on a scale (10 points total) | Baseline to Weeks 52 |
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| Secondary | Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total VAS Scores - by Treatment Week | The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" in the Pain section and "No muscle spasm" and "worst muscle spasm" in the Muscle Spasm section, used to measure intensity in pain and various other areas. The patient marks a point on the line corresponding to their pain intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm for each section. The total score is achieved by summing the two individual scores. Higher scores represent worse outcomes. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Count of Participants | Participants | Baseline to Weeks 52 |
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| Secondary | Summary of PD Medication Dose Changes by Visit | The following table depicts the count of participants that decreased, increased, or did not change their Parkinson's disease medication dosage over the course of the study at various timepoints. The safety analysis set (30 patients in Placebo, 30 patients in HB-adMSCs) was assessed at the various timepoints. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. Additionally, some patients missed assessments at various timepoints. | Posted | Count of Participants | Participants | Baseline to Weeks 52 |
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| Secondary | Summary of PD Medication Reinstatement by Visit | The table prior to this one depicts the count of participants that decreased, increased, or did not change their Parkinson's disease medication dosage over the course of the study at various timepoints. This table depicts the count of participants that reinstated their dose of Parkinson's disease medications after decreasing it throughout the clinical trial. The safety analysis set (30 patients in Placebo, 30 patients in HB-adMSCs) was assessed at the various timepoints. | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. Additionally, some patients missed assessments at various timepoints. | Posted | Count of Participants | Participants | Baseline to Weeks 52 |
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| Secondary | Treatment Emergent Adverse Events (Subjects With >= 1 Adverse Event) - Summary - Safety Analysis Set | Unit (# of participants) - Treatment emergent Adverse events (Subjects with >= 1 adverse event) - Summary - Safety analysis set. Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24). | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. Additionally, some patients missed assessments at various timepoints. | Posted | Count of Participants | Participants | Baseline to Week 24 |
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| Secondary | Treatment Emergent Adverse Events (Serious AEs) - Summary - Safety Analysis Set | Unit (# of participants) - Treatment emergent Adverse events (Serious AEs) - Summary - Safety analysis set. Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24). | The total number of enrolled participants in this study (the safety analysis set) that have had an occurrence of at least 1 adverse event is 21 placebo participants and 24 treatment participants. | Posted | Count of Participants | Participants | Baseline to Week 24 |
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| Secondary | Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52] | Unit (x10^9 cells/L) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline to Weeks 52 |
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| Secondary | Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52] | Unit (%) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | % of white blood cell count | Baseline to Weeks 52 |
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| Secondary | Change From Baseline Laboratory Values - CBC (g/dL) [Time Frame: Baseline to Week 52] | Unit (g/dL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | g/dL | Baseline to Weeks 52 |
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| Secondary | Change From Baseline Laboratory Values - CBC (pg) [Time Frame: Baseline to Week 52] | Unit (pg) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | pg | Baseline to Weeks 52 |
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| Secondary | Change From Baseline Laboratory Values - CBC (fL) [Time Frame: Baseline to Week 52] | Unit (fL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | fL | Baseline to Weeks 52 |
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| Secondary | Change From Baseline Laboratory Values - CBC (10^12/L) [Time Frame: Baseline to Week 52] | Unit (10^12/L) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | cells * 10^12/L | Baseline to Weeks 52 |
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| Secondary | Change From Baseline Laboratory Values - CMP (g/dL) [Time Frame: Baseline to Week 52] | Unit (g/dL) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | g/dL | Baseline to Weeks 52 |
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| Secondary | Change From Baseline Laboratory Values - CMP (Ratio) [Time Frame: Baseline to Week 52] | Unit (Ratio) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Ratio | Baseline to Weeks 52 |
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| Secondary | Change From Baseline Laboratory Values - CMP (IU/L) [Time Frame: Baseline to Week 52] | Unit (IU/L) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | IU/L | Baseline to Weeks 52 |
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| Secondary | Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52] | Unit (mg/dL) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | mg/dL | Baseline to Weeks 52 |
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| Secondary | Change From Baseline Laboratory Values - CMP (mmol/L) [Time Frame: Baseline to Week 52] | Unit (mmol/L) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | mmol/L | Baseline to Weeks 52 |
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| Secondary | Change From Baseline Laboratory Values - CMP (mL/Min/1.73 m^2) [Time Frame: Baseline to Week 52] | Unit (mL/min/1.73 m^2) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | mL/min/1.73 m^2 | Baseline to Weeks 52 |
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| Secondary | Change From Baseline Laboratory Values - Coagulation Panel (Ratio) [Time Frame: Baseline to Week 52] | Unit (Ratio) - Change From Baseline Clinical Laboratory Coagulation Panel by Treatment Week - Descriptive Statistics - Safety Analysis Set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Ratio | Baseline to Weeks 52 |
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| Secondary | Change From Baseline Laboratory Values - Coagulation Panel (Sec.) [Time Frame: Baseline to Week 52] | Unit (sec.) - Change From Baseline Clinical Laboratory Coagulation Panel by Treatment Week - Descriptive Statistics - Safety Analysis Set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | seconds | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in Vital Signs (Diastolic Blood Pressure - mmHg) | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | mmHg | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in Vital Signs (Heart Rate - Beats/Min) | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | beats/min | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in Vital Signs (Oxygen Saturation - %) | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | SPO2% | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in Vital Signs (Respiration Rate - Breaths/Min) | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Breaths/min | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in Vital Signs (Systolic Blood Pressure - mmHg) | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | mmHg | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in Vital Signs (Temperature - Celsius) | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | Celsius | Baseline to Weeks 52 |
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| Secondary | Change From Baseline in Vital Signs (Weight - kg) | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Mean | Standard Deviation | kg | Baseline to Weeks 52 |
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| Secondary | Physical Examination - by Treatment Week - Abdomen | Physical examination - by treatment week - Summary - Safety analysis set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Count of Participants | Participants | Baseline to Weeks 52 |
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| Secondary | Physical Examination - by Treatment Week - Cardiovascular | Physical examination - by treatment week - Summary - Safety analysis set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Count of Participants | Participants | Baseline to Weeks 52 |
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| Secondary | Physical Examination - by Treatment Week - HEENT | Physical examination - by treatment week - Summary - Safety analysis set - Head, Eyes, Ears, Nose, and Throat | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Count of Participants | Participants | Baseline to Weeks 52 |
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| Secondary | Physical Examination - by Treatment Week - Lymph Node | Physical examination - by treatment week - Summary - Safety analysis set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Count of Participants | Participants | Baseline to Weeks 52 |
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| Secondary | Physical Examination - by Treatment Week - Musculoskeletal | Physical examination - by treatment week - Summary - Safety analysis set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Count of Participants | Participants | Baseline to Weeks 52 |
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| Secondary | Physical Examination - by Treatment Week - Neurological | Physical examination - by treatment week - Summary - Safety analysis set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Count of Participants | Participants | Baseline to Weeks 52 |
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| Secondary | Physical Examination - by Treatment Week - Respiratory | Physical examination - by treatment week - Summary - Safety analysis set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Count of Participants | Participants | Baseline to Weeks 52 |
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| Secondary | Physical Examination - by Treatment Week - Skin | Physical examination - by treatment week - Summary - Safety analysis set | The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. | Posted | Count of Participants | Participants | Baseline to Weeks 52 |
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| 0 |
| 30 |
| 1 |
| 30 |
| 24 |
| 30 |
| EG001 | Placebo | Placebo will be administered intravenously to study participants who qualify. Other Names: Sterile Saline Solution 0.9% | 0 | 30 | 0 | 30 | 21 | 30 |
| Tremor | Nervous system disorders | Non-systematic Assessment |
|
| Dyskinesia | Nervous system disorders | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | Non-systematic Assessment |
|
| Bradykinesia | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Dystonia | Nervous system disorders | Non-systematic Assessment |
|
| Freezing phenomenon | Nervous system disorders | Non-systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | Non-systematic Assessment |
|
| Fine motor skill dysfunction | Nervous system disorders | Non-systematic Assessment |
|
| Movement disorder | Nervous system disorders | Non-systematic Assessment |
|
| Speech disorder | Nervous system disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Influenza like illness | General disorders | Non-systematic Assessment |
|
| Asthenia | General disorders | Non-systematic Assessment |
|
| Gait disturbance | General disorders | Non-systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Drug ineffective | General disorders | Non-systematic Assessment |
|
| Peripheral swelling | General disorders | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Helicobacter infection | Infections and infestations | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Muscle rigidity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Eye contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | Non-systematic Assessment |
|
| Hallucination, auditory | Psychiatric disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | Non-systematic Assessment |
|
| Hernia repair | Surgical and medical procedures | Non-systematic Assessment |
|
| Knee operation | Surgical and medical procedures | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | Non-systematic Assessment |
|
| Prostate specific antigen increased | Investigations | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Incontinence | Renal and urinary disorders | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part III scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.6819 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.053 | Standard Error of the Mean | 2.552 | 2-Sided | 95 | -4.09 | 6.20 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part III scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.2629 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -2.655 | Standard Error of the Mean | 2.339 | 2-Sided | 95 | -7.38 | 2.07 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part III scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.1995 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -3.822 | Standard Error of the Mean | 2.931 | 2-Sided | 95 | -9.74 | 2.10 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part III scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.0023 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -9.322 | Standard Error of the Mean | 2.866 | 2-Sided | 95 | -15.11 | -3.54 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part III scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.9187 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.473 | Standard Error of the Mean | 4.604 | 2-Sided | 95 | -9.77 | 8.82 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part III scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline Total MDS-UPDRS Part III score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.2572 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.390 | Standard Deviation | 2.172 | 2-Sided | 95 | -2.923 | 5.635 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part III scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline Total MDS-UPDRS Part III score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.7097 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -1.112 | Standard Deviation | 2.000 | 2-Sided | 95 | -5.120 | 2.723 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part III scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline Total MDS-UPDRS Part III score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.7225 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -1.327 | Standard Deviation | 2.328 | 2-Sided | 95 | -5.860 | 3.242 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part III scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline Total MDS-UPDRS Part III score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | -5.516 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -5.516 | Standard Deviation | 2.279 | 2-Sided | 95 | -9.920 | -1.039 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part III scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline Total MDS-UPDRS Part III score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.6211 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.598 | Standard Deviation | 1.923 | 2-Sided | 95 | -4.307 | 3.197 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| No |
|
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| 0.1388 |
This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. |
| Superiority |
| t-test, 2 sided | 0.2633 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.4789 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.6971 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.6599 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part II scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.1038 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.766 | Standard Error of the Mean | 1.063 | 2-Sided | 95 | -0.38 | 3.91 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part II scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.4034 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.016 | Standard Error of the Mean | 1.204 | 2-Sided | 95 | -1.41 | 3.44 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part II scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.8078 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.308 | Standard Error of the Mean | 1.258 | 2-Sided | 95 | -2.23 | 2.84 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part II scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.9497 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Median Difference (Net) | -0.067 | Standard Error of the Mean | 1.058 | 2-Sided | 95 | -2.20 | 2.07 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part II scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.7758 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.456 | Standard Error of the Mean | 1.590 | 2-Sided | 95 | -3.66 | 2.75 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part II scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline Total MDS-UPDRS Part II score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.0314 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.854 | Standard Deviation | 1.001 | 2-Sided | 95 | -0.101 | 3.835 | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part II scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline Total MDS-UPDRS Part II score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.1432 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.202 | Standard Deviation | 1.135 | 2-Sided | 95 | -0.995 | 3.428 | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part II scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline Total MDS-UPDRS Part II score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.3075 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.571 | Standard Deviation | 1.160 | 2-Sided | 95 | -1.688 | 2.841 | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part II scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline Total MDS-UPDRS Part II score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.4383 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.165 | Standard Deviation | 0.998 | 2-Sided | 95 | -1.740 | 2.158 | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part II scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline Total MDS-UPDRS Part II score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.3649 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.390 | Standard Deviation | 1.171 | 2-Sided | 95 | -1.856 | 2.759 | Superiority |
| No |
|
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| 0.9368 |
This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. |
| Superiority |
| t-test, 2 sided | 0.5810 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.6192 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.7400 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.3367 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part I scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.8228 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.208 | Standard Error of the Mean | 0.925 | 2-Sided | 95 | -2.07 | 1.66 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part I scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.8808 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.167 | Standard Error of the Mean | 1.104 | 2-Sided | 95 | -2.06 | 2.39 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part I scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.8244 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.292 | Standard Error of the Mean | 1.306 | 2-Sided | 95 | -2.34 | 2.92 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part I scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.4497 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -1.083 | Standard Error of the Mean | 1.421 | 2-Sided | 95 | -3.94 | 1.78 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part I scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.2337 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -1.620 | Standard Error of the Mean | 1.342 | 2-Sided | 95 | -4.32 | 1.08 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part I scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline Total MDS-UPDRS Part I score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.5706 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.162 | Standard Deviation | 0.896 | 2-Sided | 95 | -1.855 | 1.666 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part I scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline Total MDS-UPDRS Part I score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.4027 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.261 | Standard Deviation | 1.048 | 2-Sided | 95 | -1.783 | 2.329 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part I scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline Total MDS-UPDRS Part I score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.3945 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.328 | Standard Deviation | 1.218 | 2-Sided | 95 | -2.085 | 2.688 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part I scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline Total MDS-UPDRS Part I score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.7230 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.783 | Standard Deviation | 1.269 | 2-Sided | 95 | -3.267 | 1.671 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part I scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline Total MDS-UPDRS Part I score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.7821 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.851 | Standard Deviation | 1.100 | 2-Sided | 95 | -2.974 | 1.306 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| No |
|
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| 0.7724 |
This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. |
| Superiority |
| t-test, 2 sided | 0.3287 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.4213 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.8111 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.4102 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part IV scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.6374 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.440 | Standard Error of the Mean | 0.927 | 2-Sided | 95 | -2.31 | 1.43 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part IV scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.0296 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -2.107 | Standard Error of the Mean | 0.936 | 2-Sided | 95 | -3.99 | -0.22 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part IV scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.1205 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -1.523 | Standard Error of the Mean | 0.963 | 2-Sided | 95 | -3.46 | 0.42 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part IV scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.5171 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.607 | Standard Error of the Mean | 0.929 | 2-Sided | 95 | -2.48 | 1.27 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part IV scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.1244 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -1.894 | Standard Error of the Mean | 1.207 | 2-Sided | 95 | -4.33 | 0.55 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part IV scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline Total MDS-UPDRS Part IV score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.7024 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.465 | Standard Deviation | 0.888 | 2-Sided | 95 | -2.258 | 1.222 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part IV scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline Total MDS-UPDRS Part IV score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.9839 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -1.958 | Standard Deviation | 0.904 | 2-Sided | 95 | -3.667 | -0.130 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part IV scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline Total MDS-UPDRS Part IV score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.9320 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -1.388 | Standard Deviation | 0.922 | 2-Sided | 95 | -3.134 | 0.485 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part IV scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline Total MDS-UPDRS Part IV score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.6957 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.458 | Standard Deviation | 0.902 | 2-Sided | 95 | -2.208 | 1.333 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in MDS-UPDRS Part IV scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline Total MDS-UPDRS Part IV score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.9049 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -1.196 | Standard Deviation | 0.905 | 2-Sided | 95 | -2.898 | 0.643 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| No |
|
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| 131End of Study (Visit 8 - Week 52) |
|
|
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| 0.6595 |
This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. |
| Superiority |
| t-test, 2 sided | 0.9919 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.3808 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.2082 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.9457 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| 0.8581 |
This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. |
| Superiority |
| t-test, 2 sided | 0.4469 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.4119 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.4161 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.5132 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| 0.5072 |
This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. |
| Superiority |
| t-test, 2 sided | 0.9165 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.3373 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.1275 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.9963 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| 0.1103 |
This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. |
| Superiority |
| t-test, 2 sided | 0.9693 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.7300 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.1821 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.2237 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| 0.3865 |
This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. |
| Superiority |
| t-test, 2 sided | 0.9650 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.2015 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.6516 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.4155 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| 0.5505 |
This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. |
| Superiority |
| t-test, 2 sided | 0.6051 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.6191 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.6698 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.3231 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| 0.4257 |
This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. |
| Superiority |
| t-test, 2 sided | 0.7186 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.4376 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.6399 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.2027 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| 0.1937 |
This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. |
| Superiority |
| t-test, 2 sided | 0.6202 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.3935 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.9297 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.7879 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.5837 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.728 | Standard Error of the Mean | 3.130 | 2-Sided | 95 | -4.58 | 8.03 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.7122 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.311 | Standard Error of the Mean | 3.531 | 2-Sided | 95 | -5.80 | 8.42 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.2093 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 4.644 | Standard Error of the Mean | 3.639 | 2-Sided | 95 | -2.71 | 12.00 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.0644 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 6.519 | Standard Error of the Mean | 3.431 | 2-Sided | 95 | -0.41 | 13.44 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.6608 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.178 | Standard Error of the Mean | 2.664 | 2-Sided | 95 | -4.21 | 6.56 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
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| Infusion 4 (Visit 5 - Week 12) |
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| Infusion 5 (Visit 6 - Week 16) |
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| Infusion 6 (Visit 7 - Week 20) |
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| End of Study (Visit 8 - Week 52) |
|
|
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.6079 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 2.074 | Standard Error of the Mean | 4.013 | 2-Sided | 95 | -6.01 | 10.16 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.1803 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 5.199 | Standard Error of the Mean | 3.820 | 2-Sided | 95 | -2.50 | 12.89 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.2084 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 6.241 | Standard Error of the Mean | 4.885 | 2-Sided | 95 | -3.61 | 16.10 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.1277 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 4.991 | Standard Error of the Mean | 3.210 | 2-Sided | 95 | -1.49 | 11.47 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.2266 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 5.982 | Standard Error of the Mean | 4.871 | 2-Sided | 95 | -3.86 | 15.83 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
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| Infusion 4 (Visit 5 - Week 12) |
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| Infusion 5 (Visit 6 - Week 16) |
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| Infusion 6 (Visit 7 - Week 20) |
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| End of Study (Visit 8 - Week 52) |
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| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.7974 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.913 | Standard Error of the Mean | 3.533 | 2-Sided | 95 | -6.21 | 8.04 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.9056 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.413 | Standard Error of the Mean | 3.460 | 2-Sided | 95 | -6.56 | 7.39 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.4348 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 2.913 | Standard Error of the Mean | 3.696 | 2-Sided | 95 | -4.53 | 10.36 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.1529 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 5.080 | Standard Error of the Mean | 3.493 | 2-Sided | 95 | -1.96 | 12.12 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.7187 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -1.111 | Standard Error of the Mean | 3.063 | 2-Sided | 95 | -7.31 | 5.08 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
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| Infusion 4 (Visit 5 - Week 12) |
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| Infusion 5 (Visit 6 - Week 16) |
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| Infusion 6 (Visit 7 - Week 20) |
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| End of Study (Visit 8 - Week 52) |
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| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.1063 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 5.338 | Standard Error of the Mean | 3.237 | 2-Sided | 95 | -1.19 | 11.86 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.9108 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.391 | Standard Error of the Mean | 3.471 | 2-Sided | 95 | -7.38 | 6.59 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.8916 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.651 | Standard Error of the Mean | 4.747 | 2-Sided | 95 | -8.92 | 10.22 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.0880 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 7.422 | Standard Error of the Mean | 4.257 | 2-Sided | 95 | -1.15 | 15.99 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.2595 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 6.337 | Standard Error of the Mean | 5.545 | 2-Sided | 95 | -4.85 | 17.53 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
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| Infusion 4 (Visit 5 - Week 12) |
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| Infusion 5 (Visit 6 - Week 16) |
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| Infusion 6 (Visit 7 - Week 20) |
|
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| End of Study (Visit 8 - Week 52) |
|
|
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.3135 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 4.078 | Standard Error of the Mean | 4.000 | 2-Sided | 95 | -3.98 | 12.14 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.4564 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 2.620 | Standard Error of the Mean | 3.486 | 2-Sided | 95 | -4.41 | 9.64 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.0703 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 8.036 | Standard Error of the Mean | 4.336 | 2-Sided | 95 | -0.69 | 16.77 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.2172 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 5.536 | Standard Error of the Mean | 4.413 | 2-Sided | 95 | -3.40 | 14.47 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.2746 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 6.141 | Standard Error of the Mean | 5.547 | 2-Sided | 95 | -5.06 | 17.34 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
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| Infusion 4 (Visit 5 - Week 12) |
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| Infusion 5 (Visit 6 - Week 16) |
|
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| Infusion 6 (Visit 7 - Week 20) |
|
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| End of Study (Visit 8 - Week 52) |
|
|
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.6491 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.985 | Standard Error of the Mean | 4.331 | 2-Sided | 95 | -6.76 | 10.73 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.4494 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 3.340 | Standard Error of the Mean | 4.374 | 2-Sided | 95 | -5.48 | 12.16 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.5632 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 2.610 | Standard Error of the Mean | 4.480 | 2-Sided | 95 | -6.42 | 11.65 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.5007 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 2.923 | Standard Error of the Mean | 4.305 | 2-Sided | 95 | -5.75 | 11.60 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.6468 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 2.654 | Standard Error of the Mean | 5.750 | 2-Sided | 95 | -8.95 | 14.26 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
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| Infusion 4 (Visit 5 - Week 12) |
|
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| Infusion 5 (Visit 6 - Week 16) |
|
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| Infusion 6 (Visit 7 - Week 20) |
|
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| End of Study (Visit 8 - Week 52) |
|
|
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.2321 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 11.340 | Standard Error of the Mean | 9.359 | 2-Sided | 95 | -7.52 | 30.20 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.9200 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.924 | Standard Error of the Mean | 9.146 | 2-Sided | 95 | -17.50 | 19.35 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.1199 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 14.465 | Standard Error of the Mean | 9.123 | 2-Sided | 95 | -3.91 | 32.84 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.2916 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 10.299 | Standard Error of the Mean | 9.650 | 2-Sided | 95 | -9.14 | 29.74 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.4137 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -8.483 | Standard Error of the Mean | 10.273 | 2-Sided | 95 | -29.23 | 12.27 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
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| Infusion 4 (Visit 5 - Week 12) |
|
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| Infusion 5 (Visit 6 - Week 16) |
|
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| Infusion 6 (Visit 7 - Week 20) |
|
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| End of Study (Visit 8 - Week 52) |
|
|
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.1012 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -17.697 | Standard Error of the Mean | 10.576 | 2-Sided | 95 | -39.00 | 3.61 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.4083 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -9.364 | Standard Error of the Mean | 11.218 | 2-Sided | 95 | -31.96 | 13.23 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.7171 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -3.808 | Standard Error of the Mean | 10.443 | 2-Sided | 95 | -24.84 | 17.22 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.5035 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 7.303 | Standard Error of the Mean | 10.826 | 2-Sided | 95 | -14.52 | 29.12 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.6228 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -6.078 | Standard Error of the Mean | 12.253 | 2-Sided | 95 | -30.90 | 18.74 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
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| Infusion 4 (Visit 5 - Week 12) |
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| Infusion 5 (Visit 6 - Week 16) |
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| Infusion 6 (Visit 7 - Week 20) |
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| End of Study (Visit 8 - Week 52) |
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| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.7090 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.293 | Standard Deviation | 2.362 | 2-Sided | 95 | -3.243 | 6.024 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.5359 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.250 | Standard Deviation | 2.521 | 2-Sided | 95 | -4.845 | 5.097 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.8487 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 2.576 | Standard Deviation | 2.512 | 2-Sided | 95 | -2.285 | 7.614 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.9511 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 4.116 | Standard Deviation | 2.446 | 2-Sided | 95 | -0.822 | 8.813 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.8207 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.685 | Standard Deviation | 1.876 | 2-Sided | 95 | -2.156 | 5.226 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
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| Infusion 4 (Visit 5 - Week 12) |
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| Infusion 5 (Visit 6 - Week 16) |
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| Infusion 6 (Visit 7 - Week 20) |
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| End of Study (Visit 8 - Week 52) |
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| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.7370 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.722 | Standard Deviation | 2.754 | 2-Sided | 95 | -3.630 | 7.135 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.9239 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 3.840 | Standard Deviation | 2.651 | 2-Sided | 95 | -1.242 | 9.123 | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.8978 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 3.983 | Standard Deviation | 3.135 | 2-Sided | 95 | -2.125 | 10.232 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.9325 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 3.632 | Standard Deviation | 2.399 | 2-Sided | 95 | -1.218 | 8.217 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.9193 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 3.093 | Standard Deviation | 2.169 | 2-Sided | 95 | -1.002 | 7.591 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
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| Infusion 4 (Visit 5 - Week 12) |
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| Infusion 5 (Visit 6 - Week 16) |
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| Infusion 6 (Visit 7 - Week 20) |
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| End of Study (Visit 8 - Week 52) |
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| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.7153 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.469 | Standard Deviation | 2.622 | 2-Sided | 95 | -3.554 | 6.715 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.5991 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.651 | Standard Deviation | 2.618 | 2-Sided | 95 | -4.520 | 5.638 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.8201 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 2.456 | Standard Deviation | 2.706 | 2-Sided | 95 | -3.039 | 7.524 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.9200 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 3.688 | Standard Deviation | 2.613 | 2-Sided | 95 | -1.459 | 8.705 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.7932 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.624 | Standard Deviation | 1.982 | 2-Sided | 95 | -2.278 | 5.401 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
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| Infusion 4 (Visit 5 - Week 12) |
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| Infusion 5 (Visit 6 - Week 16) |
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| Infusion 6 (Visit 7 - Week 20) |
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| End of Study (Visit 8 - Week 52) |
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| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.9215 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 3.469 | Standard Deviation | 2.448 | 2-Sided | 95 | -1.458 | 8.115 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.6294 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.841 | Standard Deviation | 2.596 | 2-Sided | 95 | -4.021 | 6.249 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.6682 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.318 | Standard Deviation | 3.128 | 2-Sided | 95 | -4.859 | 7.362 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.9391 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 4.605 | Standard Deviation | 2.946 | 2-Sided | 95 | -1.078 | 10.509 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.8838 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 2.559 | Standard Deviation | 2.142 | 2-Sided | 95 | -1.602 | 6.838 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
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| Infusion 4 (Visit 5 - Week 12) |
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| Infusion 5 (Visit 6 - Week 16) |
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| Infusion 6 (Visit 7 - Week 20) |
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| End of Study (Visit 8 - Week 52) |
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| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.7934 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 2.267 | Standard Deviation | 2.789 | 2-Sided | 95 | -3.358 | 7.550 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.7034 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.314 | Standard Deviation | 2.532 | 2-Sided | 95 | -3.694 | 6.309 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.9397 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 4.515 | Standard Deviation | 2.914 | 2-Sided | 95 | -1.050 | 10.357 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.8261 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 2.583 | Standard Deviation | 2.758 | 2-Sided | 95 | -2.776 | 8.056 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.8758 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 2.554 | Standard Deviation | 2.225 | 2-Sided | 95 | -1.857 | 6.845 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
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| Infusion 4 (Visit 5 - Week 12) |
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| Infusion 5 (Visit 6 - Week 16) |
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| Infusion 6 (Visit 7 - Week 20) |
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| End of Study (Visit 8 - Week 52) |
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| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.7441 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 2.071 | Standard Deviation | 3.143 | 2-Sided | 95 | -4.066 | 8.240 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.8218 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 2.812 | Standard Deviation | 3.045 | 2-Sided | 95 | -3.002 | 8.919 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.7700 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 2.300 | Standard Deviation | 3.124 | 2-Sided | 95 | -3.907 | 8.298 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.8052 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 2.567 | Standard Deviation | 2.945 | 2-Sided | 95 | -3.230 | 8.294 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.8385 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 2.331 | Standard Deviation | 2.365 | 2-Sided | 95 | -2.366 | 6.786 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
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| Infusion 4 (Visit 5 - Week 12) |
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| Infusion 5 (Visit 6 - Week 16) |
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| Infusion 6 (Visit 7 - Week 20) |
|
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| End of Study (Visit 8 - Week 52) |
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|
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.8575 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 4.193 | Standard Deviation | 3.921 | 2-Sided | 95 | -3.613 | 11.748 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.6525 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.583 | Standard Deviation | 3.955 | 2-Sided | 95 | -6.271 | 9.259 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.8730 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 4.392 | Standard Deviation | 3.875 | 2-Sided | 95 | -3.030 | 12.136 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.8654 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 4.296 | Standard Deviation | 3.850 | 2-Sided | 95 | -3.465 | 11.604 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.8280 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 2.623 | Standard Deviation | 2.789 | 2-Sided | 95 | -2.870 | 8.032 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.5739 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.723 | Standard Deviation | 3.963 | 2-Sided | 95 | -6.938 | 8.544 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.5970 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.983 | Standard Deviation | 4.078 | 2-Sided | 95 | -7.135 | 8.936 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.6606 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.641 | Standard Deviation | 3.944 | 2-Sided | 95 | -5.806 | 9.450 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.7653 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 2.843 | Standard Deviation | 3.951 | 2-Sided | 95 | -5.097 | 10.263 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in SF-36 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in SF-36 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.6832 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.389 | Standard Deviation | 2.900 | 2-Sided | 95 | -4.233 | 7.031 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| 0.5866 |
This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. |
| Superiority |
| t-test, 2 sided | 0.6934 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.7596 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.0890 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.1930 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in PFS-16 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.5331 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -1.535 | Standard Error of the Mean | 2.443 | 2-Sided | 95 | -6.46 | 3.39 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in PFS-16 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.5475 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -1.868 | Standard Error of the Mean | 3.082 | 2-Sided | 95 | -8.08 | 4.34 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in PFS-16 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.4881 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -2.201 | Standard Error of the Mean | 3.149 | 2-Sided | 95 | -8.54 | 4.14 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in PFS-16 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.0208 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -7.743 | Standard Error of the Mean | 3.222 | 2-Sided | 95 | -14.25 | -1.24 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in PFS-16 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.3168 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -4.036 | Standard Error of the Mean | 3.976 | 2-Sided | 95 | -12.10 | 4.02 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in PFS-16 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in PFS-16 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.6048 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.522 | Standard Deviation | 1.988 | 2-Sided | 95 | -4.307 | 3.426 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in PFS-16 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in PFS-16 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.5632 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.362 | Standard Deviation | 2.267 | 2-Sided | 95 | -4.772 | 4.107 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in PFS-16 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in PFS-16 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.5811 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.514 | Standard Deviation | 2.339 | 2-Sided | 95 | -5.035 | 4.083 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in PFS-16 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in PFS-16 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.9659 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -4.284 | Standard Deviation | 2.326 | 2-Sided | 95 | -8.620 | 0.426 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in PFS-16 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in PFS-16 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.7508 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -1.292 | Standard Deviation | 1.907 | 2-Sided | 95 | -4.881 | 2.537 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| 0.6965 |
This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. |
| Superiority |
| t-test, 2 sided | 0.7807 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.9508 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.5120 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.2001 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in PDQ-39 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.7035 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.676 | Standard Error of the Mean | 1.765 | 2-Sided | 95 | -4.23 | 2.88 | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in PDQ-39 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.6842 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.790 | Standard Error of the Mean | 1.931 | 2-Sided | 95 | -4.68 | 3.10 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in PDQ-39 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.8235 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.468 | Standard Error of the Mean | 2.083 | 2-Sided | 95 | -4.67 | 3.73 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in PDQ-39 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.2541 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -2.514 | Standard Error of the Mean | 2.175 | 2-Sided | 95 | -6.90 | 1.87 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in PDQ-39 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.2324 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -3.361 | Standard Error of the Mean | 2.773 | 2-Sided | 95 | -8.96 | 2.24 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in PDQ-39 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in PDQ-39 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.5813 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.320 | Standard Deviation | 1.571 | 2-Sided | 95 | -3.396 | 2.768 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in PDQ-39 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in PDQ-39 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.5652 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.267 | Standard Deviation | 1.697 | 2-Sided | 95 | -3.535 | 3.107 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in PDQ-39 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in PDQ-39 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.4422 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.276 | Standard Deviation | 1.785 | 2-Sided | 95 | -3.206 | 3.828 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in PDQ-39 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline Total MDS-UPDRS Part III score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.8291 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -1.765 | Standard Deviation | 1.862 | 2-Sided | 95 | -5.527 | 1.824 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in PDQ-39 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in PDQ-39 scale score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.7286 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.976 | Standard Deviation | 1.587 | 2-Sided | 95 | -4.193 | 2.005 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| No |
|
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| 0.8546 |
This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. |
| Superiority |
| t-test, 2 sided | 0.8133 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.0740 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.2113 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.6787 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in VAS Pain scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.7095 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.171 | Standard Error of the Mean | 0.455 | 2-Sided | 95 | -0.75 | 1.09 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in VAS Pain scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.9933 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.004 | Standard Error of the Mean | 0.470 | 2-Sided | 95 | -0.94 | 0.95 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in VAS Pain scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.0450 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.085 | Standard Error of the Mean | 0.526 | 2-Sided | 95 | 0.03 | 2.15 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in VAS Pain score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.3191 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.423 | Standard Error of the Mean | 0.419 | 2-Sided | 95 | -0.42 | 1.27 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in VAS Pain score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.2310 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.633 | Standard Error of the Mean | 0.521 | 2-Sided | 95 | -1.68 | 0.42 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in VAS Pain score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline VAS Pain score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.3708 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.148 | Standard Deviation | 0.455 | 2-Sided | 95 | -0.745 | 1.055 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in VAS Pain scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in VAS Pain score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.4738 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.037 | Standard Deviation | 0.463 | 2-Sided | 95 | -0.823 | 0.990 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in VAS Pain scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in VAS Pain score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.0257 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 1.065 | Standard Deviation | 0.537 | 2-Sided | 95 | -0.011 | 2.105 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in VAS Pain scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in VAS Pain score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.1406 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.445 | Standard Deviation | 0.421 | 2-Sided | 95 | -0.364 | 1.289 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in VAS Pain scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in VAS Pain score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.8430 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.525 | Standard Deviation | 0.513 | 2-Sided | 95 | -1.473 | 0.535 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| 0.7845 |
| Superiority |
| t-test, 2 sided | 0.5217 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.5300 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.6445 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| t-test, 2 sided | 0.6046 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). P-value calculated using t-test by comparing pairwise with baseline values. | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in VAS Muscle Spasm scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.6631 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.233 | Standard Error of the Mean | 0.532 | 2-Sided | 95 | -0.84 | 1.31 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in VAS Muscle Spasm scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.4823 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.365 | Standard Error of the Mean | 0.515 | 2-Sided | 95 | -0.67 | 1.40 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in VAS Muscle Spasm scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.4211 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.500 | Standard Error of the Mean | 0.616 | 2-Sided | 95 | -0.74 | 1.74 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in VAS Muscle Spasm score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.3667 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.494 | Standard Error of the Mean | 0.541 | 2-Sided | 95 | -1.59 | 0.60 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in VAS Muscle Spasm score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Repeated Measures model uses an unstructured residual covariance matrix. The model includes treatment and visits as fixed factors and stratification of disease severity, age, and sex as fixed factors and baseline as the covariate. Furthermore, the model includes interaction terms between treatment and visit. | RMA | 0.4778 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.423 | Standard Error of the Mean | 0.589 | 2-Sided | 95 | -1.62 | 0.77 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in VAS Muscle Spasm score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline VAS Muscle Spasm score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.3235 | This p-value applies to data regarding infusion 3 (Visit 4 - Week 8) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.239 | Standard Deviation | 0.524 | 2-Sided | 95 | -0.810 | 1.265 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in VAS Muscle Spasm scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in VAS Muscle Spasm score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.2500 | This p-value applies to data regarding infusion 4 (Visit 5 - Week 12) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.341 | Standard Deviation | 0.515 | 2-Sided | 95 | -0.716 | 1.309 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in VAS Muscle Spasm scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in VAS Muscle Spasm score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.1996 | This p-value applies to data regarding infusion 5 (Visit 6 - Week 16) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | 0.508 | Standard Deviation | 0.605 | 2-Sided | 95 | -0.701 | 1.668 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in VAS Pain scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in VAS Pain score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.8081 | This p-value applies to data regarding infusion 6 (Visit 7 - Week 20) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.462 | Standard Deviation | 0.541 | 2-Sided | 95 | -1.508 | 0.626 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| The null hypothesis is that the difference in change from baseline to Weeks 52 in VAS Muscle Spasm scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero. Bayesian repeated measures model for Change from baseline in VAS Muscle Spasm score used. The Bayesian model include factors of disease severity, age, and sex as fixed factors and baseline as covariate. Furthermore, the model include interaction terms between treatment and visit and between baseline and visit. | RMA | 0.7317 | This p-value applies to data regarding End of Study (Visit 8 - Week 52) compared to Infusion 1/Baseline (Visit 2 - Week 0). | Mean Difference (Net) | -0.337 | Standard Deviation | 0.552 | 2-Sided | 95 | -1.390 | 0.766 | The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups | Superiority |
| No |
|
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| No change |
|
| Dose increase |
|
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| Follow-Up 1 (Visit N/A - Week 24) |
|
|
| Follow-Up 2 (Visit N/A - Week 32 |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Other (See Dose Change Table) |
|
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| Follow-Up 1 (Visit N/A - Week 24) |
|
|
| Follow-Up 2 (Visit N/A - Week 32 |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Basophils - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Basophils - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Eosinophils - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Eosinophils - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Eosinophils - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Lymphocytes - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Lymphocytes- Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Lymphocytes - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Monocytes - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Monocytes- Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Monocytes - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Neutrophils - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Neutrophils- Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Neutrophils - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Platelets - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Platelets- Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Platelets - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Leukocytes - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Leukocytes- Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Leukocytes - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Basophils/Leukocytes - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Basophils/Leukocytes - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Eosinophils/Leukocytes - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Eosinophils/Leukocytes - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Eosinophils/Leukocytes - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Hematocrit - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Hematocrit- Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Hematocrit - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Lymphocytes/Leukocytes - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Lymphocytes/Leukocytes- Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Lymphocytes/Leukocytes - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Monocytes/Leukocytes - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Monocytes/Leukocytes- Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Monocytes/Leukocytes - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Neutrophils/Leukocytes - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Neutrophils/Leukocytes- Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Neutrophils/Leukocytes - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Erythrocytes Distribution Width - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Erythrocytes Distribution Width- Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Erythrocytes Distribution Width - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Hemoglobin - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Hemoglobin - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Ery. Mean Corpuscular HGB Concentration - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Ery. Mean Corpuscular HGB Concentration - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Ery. Mean Corpuscular HGB Concentration - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Ery. Mean Corpuscular Hemoglobin - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Ery. Mean Corpuscular Hemoglobin - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Ery. Mean Corpuscular Volume - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Ery. Mean Corpuscular Volume - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Erythrocytes - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Erythrocytes - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Albumin - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Albumin - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Globulin - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Globulin - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Globulin- End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Protein - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Protein - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Protein- End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Albumin/Globulin - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Albumin/Globulin - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Urea Nitrogen/Creatinine - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Urea Nitrogen/Creatinine - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Urea Nitrogen/Creatinine- End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Alkaline Phosphatase - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Alkaline Phosphatase - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Alanine Aminotransferase - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Alanine Aminotransferase - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Alanine Aminotransferase- End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Aspartate Aminotransferase - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Aspartate Aminotransferase - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Aspartate Aminotransferase- End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Bilirubin - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Bilirubin - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Calcium- Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Calcium - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Calcium- End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Creatinine - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Creatinine - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Creatinine- End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Glucose - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Glucose - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Glucose- End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Urea Nitrogen - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Urea Nitrogen - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Urea Nitrogen- End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Chloride - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Chloride - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Carbon Dioxide - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Carbon Dioxide - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Carbon Dioxide- End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Potassium - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Potassium - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Potassium - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Sodium - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Sodium - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Sodium - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| eGFR - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| eGFR - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Prothrombin Intl. Normalized Ratio - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Prothrombin Intl. Normalized Ratio - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Prothrombin Time - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Prothrombin Time - End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Partial Thromboplastin Time - Baseline (Visit 1 - Week 1) - Absolute |
|
|
| Partial Thromboplastin Time - Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Partial Thromboplastin Time- End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Infusion 2 (Visit 3 - Week 4) - Change From Baseline |
|
|
| Infusion 3 (Visit 4 - Week 8) - Change From Baseline |
|
|
| Infusion 4 (Visit 5 - Week 12) - Change From Baseline |
|
|
| Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Infusion 6 (Visit 7 - Week 20) - Change From Baseline |
|
|
| End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Infusion 2 (Visit 3 - Week 4) - Change From Baseline |
|
|
| Infusion 3 (Visit 4 - Week 8) - Change From Baseline |
|
|
| Infusion 4 (Visit 5 - Week 12) - Change From Baseline |
|
|
| Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Infusion 6 (Visit 7 - Week 20) - Change From Baseline |
|
|
| End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Infusion 2 (Visit 3 - Week 4) - Change From Baseline |
|
|
| Infusion 3 (Visit 4 - Week 8) - Change From Baseline |
|
|
| Infusion 4 (Visit 5 - Week 12) - Change From Baseline |
|
|
| Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Infusion 6 (Visit 7 - Week 20) - Change From Baseline |
|
|
| End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Infusion 2 (Visit 3 - Week 4) - Change From Baseline |
|
|
| Infusion 3 (Visit 4 - Week 8) - Change From Baseline |
|
|
| Infusion 4 (Visit 5 - Week 12) - Change From Baseline |
|
|
| Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Infusion 6 (Visit 7 - Week 20) - Change From Baseline |
|
|
| End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Infusion 2 (Visit 3 - Week 4) - Change From Baseline |
|
|
| Infusion 3 (Visit 4 - Week 8) - Change From Baseline |
|
|
| Infusion 4 (Visit 5 - Week 12) - Change From Baseline |
|
|
| Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Infusion 6 (Visit 7 - Week 20) - Change From Baseline |
|
|
| End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Infusion 2 (Visit 3 - Week 4) - Change From Baseline |
|
|
| Infusion 3 (Visit 4 - Week 8) - Change From Baseline |
|
|
| Infusion 4 (Visit 5 - Week 12) - Change From Baseline |
|
|
| Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Infusion 6 (Visit 7 - Week 20) - Change From Baseline |
|
|
| End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Infusion 2 (Visit 3 - Week 4) - Change From Baseline |
|
|
| Infusion 3 (Visit 4 - Week 8) - Change From Baseline |
|
|
| Infusion 4 (Visit 5 - Week 12) - Change From Baseline |
|
|
| Infusion 5 (Visit 6 - Week 16) - Change From Baseline |
|
|
| Infusion 6 (Visit 7 - Week 20) - Change From Baseline |
|
|
| End of Study (Visit 8 - Week 52) - Change From Baseline |
|
|
| Abnormal |
|
| Infusion 2 (Visit 3 - Week 4) |
|
|
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Abnormal |
|
| Infusion 2 (Visit 3 - Week 4) |
|
|
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Abnormal |
|
| Infusion 2 (Visit 3 - Week 4) |
|
|
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Abnormal |
|
| Infusion 2 (Visit 3 - Week 4) |
|
|
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Abnormal |
|
| Infusion 2 (Visit 3 - Week 4) |
|
|
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Abnormal |
|
| Infusion 2 (Visit 3 - Week 4) |
|
|
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Abnormal |
|
| Infusion 2 (Visit 3 - Week 4) |
|
|
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|
| Abnormal |
|
| Infusion 2 (Visit 3 - Week 4) |
|
|
| Infusion 3 (Visit 4 - Week 8) |
|
|
| Infusion 4 (Visit 5 - Week 12) |
|
|
| Infusion 5 (Visit 6 - Week 16) |
|
|
| Infusion 6 (Visit 7 - Week 20) |
|
|
| End of Study (Visit 8 - Week 52) |
|
|