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This is a randomized, double-blind, single center, phase 2 study to assess efficacy and safety of multiple 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 24 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HB-adMSCs | Active Comparator | Autologous Hope Biosciences adipose derived mesenchymal stem cells. |
|
| Placebo | Placebo Comparator | Sterile Saline Solution 0.9% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 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 through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Laboratory Values. CBC (% of WBC) | Changes from baseline in CBC laboratory values with unit of % of white blood cell count. | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| Laboratory Values. CBC (10^9 Cells/L) | Changes from baseline in CBC laboratory values with units of 10^9 cells/L (Leukocytes, Platelets) | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| Laboratory Values. CBC (10^12 Cells/L) | Changes from baseline in CBC laboratory values with units of 10^12 cells/L. | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| Laboratory Values. CBC (pg) | Changes from baseline in CBC laboratory values with unit of pg. | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in MDS-UPDRS Part I. | 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 of 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 hepatitis 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.
Study participants who are determined by the Investigator to be unsuitable for study enrollment for other reasons
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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 |
|---|---|---|---|
| 42137372 | Derived | Vij R, Kim H, Park H, Lotfi D, Cheng T, Chang D. Evaluation of Multiple Intravenous Infusions of Autologous Adipose-Derived Mesenchymal Stem Cells in Parkinson's Disease: A Randomized, Double-Blind Clinical Trial. Parkinsons Dis. 2026 May 13;2026:9934417. doi: 10.1155/padi/9934417. eCollection 2026. |
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| ID | Title | Description |
|---|---|---|
| FG000 | HB-adMSCs | Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify. Placebo: Placebo will be administered intravenously to study participants who qualify. |
| FG001 | Placebo | Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify. Placebo: Placebo will be administered intravenously to study participants who qualify. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | HB-adMSCs | Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify. Placebo: Placebo will be administered intravenously to study participants who qualify. |
| 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 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. | Posted | Mean | Standard Deviation | score on a scale (52 points total) | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
|
Week 0 (Infusion 1) through Week 52 (End of Study)
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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 | HB-adMSCs | Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| 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, PhD | 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 | Apr 29, 2021 | Mar 8, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 18, 2023 | Mar 8, 2024 | SAP_001.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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A parallel study is a type of clinical study where two groups of treatments, A (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 | Placebo will be administered intravenously to study participants who qualify. |
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| Laboratory Values. CBC (fL) | Changes from baseline in CBC laboratory values with unit of fL. | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| Laboratory Values. CBC (g/dL) | Changes from baseline in CBC laboratory values with unit of g/dL. | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| Laboratory Values. CBC (% Difference in Volume and Size of RBC) | Changes from baseline in CBC laboratory values with unit of % difference in volume and size of RBC | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| Laboratory Values. CBC (% of Total Blood Cell Count) | Changes from baseline in CBC laboratory values with unit of % of total blood cell count. | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| Vital Signs. - Blood Pressure (mmHg) | Change from baseline in Blood Pressure. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Weight in kg. | Change from baseline in Weight in kg. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Laboratory Values. CMP (mg/dL) | Change from baseline in CMP values with units of mg/dL | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| Laboratory Values. CMP (g/dL) | Changes from baseline in CMP laboratory values with units of g/dL | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| Laboratory Values. CMP (IU/L) | Changes from baseline in CMP laboratory values with units of IU/L. | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| Laboratory Values. CMP (mL/Min/1.73m^2) | Changes from baseline in CMP laboratory values with units of mL/min/1.73m^2. | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| Laboratory Values. CMP (mmol/L) | Changes from baseline in CMP laboratory values with units of mmol/L. | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| Laboratory Values. CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL)) | Changes from baseline in CMP laboratory values with units of Ratio: Albumin(g/dL) to Calc. Globulin(g/dL) | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| Laboratory Values. CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL)) | Changes from baseline in CMP laboratory values with units of Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL) | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| Laboratory Values. Coagulation Panel (Seconds) | Changes from baseline in Coagulation Panel values with units of seconds. | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds)) | Changes from baseline in Coagulation laboratory values with units of Ratio: Prothrombin time (seconds) / Mean normal prothrombin time (seconds). | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| Vital Signs. - Respiratory Rate (Breaths Per Minute) | Changes from Baseline in Respiratory Rate. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Vital Signs. - Heart Rate (Beats Per Minute) | Change from baseline in Heart Rate. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Vital Signs. - Body Temperature (Celsius ) | Change from baseline in Body Temperature. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Change From Baseline in MDS-UPDRS Part III. | 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 III tests "Motor examination". Motor Examination includes 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. There are 18 items included in Part III. Part III score ranges from 0 - 132; 32 and below is mild, 59 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 through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Change From Baseline in MDS-UPDRS Part IV. | 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 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 through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Change From Baseline in Neuro-QOL. - Communication | Communication - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The communication short form has 5 questions regarding communicative abilities of the patient, and each question ranges from 0 points to 5 points (making the total 25 points). A higher score represents a better outcome. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Change From Baseline in Neuro-QOL. - Social Roles and Activities | Ability to Participate in Social Roles and Activities - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Ability to Participate in Social Roles and Activities" short form has 8 questions regarding social abilities of the patient (familial and friend relationships), and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Changes From Baseline in Neuro-QOL. - Anxiety | Anxiety - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Anxiety" short form has 8 questions regarding the anxiety level of the patient (inquiring about level of uneasiness and worry), and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Change From Baseline in Neuro-QOL. - Depression | Depression - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Depression" short form has 8 questions regarding the depression level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Change From Baseline in Neuro-QOL. - Dyscontrol | Emotional and Behavioral Dyscontrol - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Dyscontrol" short form has 8 questions regarding the emotional and behavioral dyscontrol level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Changes From Baseline in Neuro-QOL. - Fatigue | Fatigue - Short Form Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Fatigue" short form has 8 questions regarding the Fatigue level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Change From Baseline in Neuro-QOL. - Mobility | Lower Extremity Function (Mobility) - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Mobility" short form has 8 questions regarding the Lower Extremity Function (Mobility) level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Change From Baseline in Neuro-QOL. - Well-Being | Positive Affect and Well-Being - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Positive Affect and Well-Being" short form has 8 questions regarding the well-being level of the patient, and each question ranges from 0 points to 5 points (making the total 45 points). A higher score represents a better outcome. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Change From Baseline in Neuro-QOL. - Sleep | Sleep Disturbance - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Sleep disturbance" short form has 8 questions regarding the sleep level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Change From Baseline in Neuro-QOL. - Fine Motor | Upper Extremity Function (Fine Motor, ADL) - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Upper Extremity Function (Fine Motor, ADL)" short form has 8 questions regarding the fine motor levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Change From Baseline in Neuro-QOL. - Stigma | Stigma-Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Stigma" short form has 8 questions regarding the stigma levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Change From Baseline in Neuro-QOL. - Social Roles | Satisfaction with Social Roles and Activities - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Satisfaction with Social Roles and Activities" short form has 8 questions regarding the satisfaction levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Change From Baseline in Neuro-QOL. - Cognition | Cognition Function- Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Cognition Function" short form has 8 questions regarding the cognition function levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16). | The Parkinson's disease fatigue scale (PFS-16) is an 16 question assessment that measures the level of fatigue in patients diagnosed with Parkinson's disease. Each question has 5 answer choices established as "strongly disagree", "disagree", "do not agree or disagree", "agree", and "strongly agree", which are scored as 1 to 5, respectively, making the total score from 16 to 80 points. Higher score represents a worse outcome. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39). | The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100. The final reported score (summary index) is calculated by averaging the 8 scaled scores. Higher score represents a worse outcome. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Change From Baseline in Total Visual Analog Scale | Visual Analog Scale for Pain and Muscle Spasm. The pain and muscle spasm VAS is a unidimensional measure of pain/ muscle spasm intensity, used to record patients' pain progression and muscle spasm progression, or compare pain and muscle spasm severity between patients with similar conditions. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark summed with the distance (mm) on the 10-cm line between the "no muscle spasm" anchor and the patient's mark, providing a range of scores from 0-200. A higher score indicates greater pain/spasm intensity. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Change From Baseline in Dosage of Carbidopa/Levodopa | Dosage of medications. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
| Change From Baseline in Vital Signs. - Oxygen Saturation. | Changes in Oxygen Saturation. | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify. Placebo: Placebo will be administered intravenously to study participants who qualify. |
| 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 | centimeter |
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| Weight | Mean | Standard Deviation | kilograms |
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Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9). |
| OG001 | Placebo | Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9). |
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| Primary | Laboratory Values. CBC (% of WBC) | Changes from baseline in CBC laboratory values with unit of % of white blood cell count. | Posted | Mean | Standard Deviation | % of white blood cell count | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Primary | Laboratory Values. CBC (10^9 Cells/L) | Changes from baseline in CBC laboratory values with units of 10^9 cells/L (Leukocytes, Platelets) | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Primary | Laboratory Values. CBC (10^12 Cells/L) | Changes from baseline in CBC laboratory values with units of 10^12 cells/L. | Posted | Mean | Standard Deviation | 10^12 cells/L | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Primary | Laboratory Values. CBC (pg) | Changes from baseline in CBC laboratory values with unit of pg. | Posted | Mean | Standard Deviation | pg | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Primary | Laboratory Values. CBC (fL) | Changes from baseline in CBC laboratory values with unit of fL. | Posted | Mean | Standard Deviation | fL | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Primary | Laboratory Values. CBC (g/dL) | Changes from baseline in CBC laboratory values with unit of g/dL. | Posted | Mean | Standard Deviation | g/dL | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Primary | Laboratory Values. CBC (% Difference in Volume and Size of RBC) | Changes from baseline in CBC laboratory values with unit of % difference in volume and size of RBC | Posted | Mean | Standard Deviation | % difference in volume and size of RBC | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Primary | Laboratory Values. CBC (% of Total Blood Cell Count) | Changes from baseline in CBC laboratory values with unit of % of total blood cell count. | Posted | Mean | Standard Deviation | % of total blood cell count | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Primary | Vital Signs. - Blood Pressure (mmHg) | Change from baseline in Blood Pressure. | Posted | Mean | Standard Deviation | mmHg | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Primary | Weight in kg. | Change from baseline in Weight in kg. | Posted | Mean | Standard Deviation | kg | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Primary | Laboratory Values. CMP (mg/dL) | Change from baseline in CMP values with units of mg/dL | Posted | Mean | Standard Deviation | mg/dL | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Primary | Laboratory Values. CMP (g/dL) | Changes from baseline in CMP laboratory values with units of g/dL | Posted | Mean | Standard Deviation | g/dL | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Primary | Laboratory Values. CMP (IU/L) | Changes from baseline in CMP laboratory values with units of IU/L. | Posted | Mean | Standard Deviation | IU/L | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Primary | Laboratory Values. CMP (mL/Min/1.73m^2) | Changes from baseline in CMP laboratory values with units of mL/min/1.73m^2. | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Primary | Laboratory Values. CMP (mmol/L) | Changes from baseline in CMP laboratory values with units of mmol/L. | Posted | Mean | Standard Deviation | mmol/L | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Primary | Laboratory Values. CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL)) | Changes from baseline in CMP laboratory values with units of Ratio: Albumin(g/dL) to Calc. Globulin(g/dL) | Posted | Mean | Standard Deviation | Ratio: Albumin(g/dL) to Globulin(g/dL) | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Primary | Laboratory Values. CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL)) | Changes from baseline in CMP laboratory values with units of Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL) | Posted | Mean | Standard Deviation | Ratio:Urea nit.(mg/dL) /creatinin(mg/dL) | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Primary | Laboratory Values. Coagulation Panel (Seconds) | Changes from baseline in Coagulation Panel values with units of seconds. | Posted | Mean | Standard Deviation | seconds | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Primary | Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds)) | Changes from baseline in Coagulation laboratory values with units of Ratio: Prothrombin time (seconds) / Mean normal prothrombin time (seconds). | Posted | Mean | Standard Deviation | Ratio: PT (seconds) / MNPT (seconds) | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Primary | Vital Signs. - Respiratory Rate (Breaths Per Minute) | Changes from Baseline in Respiratory Rate. | Posted | Mean | Standard Deviation | breaths/minute | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Primary | Vital Signs. - Heart Rate (Beats Per Minute) | Change from baseline in Heart Rate. | Posted | Mean | Standard Deviation | beats/minute | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Primary | Vital Signs. - Body Temperature (Celsius ) | Change from baseline in Body Temperature. | Posted | Mean | Standard Deviation | Celsius | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Secondary | Change From Baseline in MDS-UPDRS Part I. | 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. | Posted | Mean | Standard Deviation | score on a scale (52 points total) | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Secondary | Change From Baseline in MDS-UPDRS Part III. | 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 III tests "Motor examination". Motor Examination includes 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. There are 18 items included in Part III. Part III score ranges from 0 - 132; 32 and below is mild, 59 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. | Posted | Mean | Standard Deviation | score on a scale (132 points total) | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Secondary | Change From Baseline in MDS-UPDRS Part IV. | 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 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. | Posted | Mean | Standard Deviation | score on a scale (24 points total) | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Secondary | Change From Baseline in Neuro-QOL. - Communication | Communication - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The communication short form has 5 questions regarding communicative abilities of the patient, and each question ranges from 0 points to 5 points (making the total 25 points). A higher score represents a better outcome. | Posted | Mean | Standard Deviation | score on a scale (25 points total) | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Secondary | Change From Baseline in Neuro-QOL. - Social Roles and Activities | Ability to Participate in Social Roles and Activities - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Ability to Participate in Social Roles and Activities" short form has 8 questions regarding social abilities of the patient (familial and friend relationships), and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome. | Posted | Mean | Standard Deviation | score on a scale (40 points total) | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Secondary | Changes From Baseline in Neuro-QOL. - Anxiety | Anxiety - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Anxiety" short form has 8 questions regarding the anxiety level of the patient (inquiring about level of uneasiness and worry), and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome. | Posted | Mean | Standard Deviation | score on a scale (40 points total) | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Secondary | Change From Baseline in Neuro-QOL. - Depression | Depression - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Depression" short form has 8 questions regarding the depression level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome. | Posted | Mean | Standard Deviation | score on a scale (40 points total) | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Secondary | Change From Baseline in Neuro-QOL. - Dyscontrol | Emotional and Behavioral Dyscontrol - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Dyscontrol" short form has 8 questions regarding the emotional and behavioral dyscontrol level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome. | Posted | Mean | Standard Deviation | score on a scale (40 points total) | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Secondary | Changes From Baseline in Neuro-QOL. - Fatigue | Fatigue - Short Form Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Fatigue" short form has 8 questions regarding the Fatigue level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome. | Posted | Mean | Standard Deviation | score on a scale (40 points total) | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Secondary | Change From Baseline in Neuro-QOL. - Mobility | Lower Extremity Function (Mobility) - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Mobility" short form has 8 questions regarding the Lower Extremity Function (Mobility) level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome. | Posted | Mean | Standard Deviation | score on a scale (40 points total) | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Secondary | Change From Baseline in Neuro-QOL. - Well-Being | Positive Affect and Well-Being - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Positive Affect and Well-Being" short form has 8 questions regarding the well-being level of the patient, and each question ranges from 0 points to 5 points (making the total 45 points). A higher score represents a better outcome. | Posted | Mean | Standard Deviation | score on a scale (45 points total) | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Secondary | Change From Baseline in Neuro-QOL. - Sleep | Sleep Disturbance - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Sleep disturbance" short form has 8 questions regarding the sleep level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome. | Posted | Mean | Standard Deviation | score on a scale (40 points total) | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Secondary | Change From Baseline in Neuro-QOL. - Fine Motor | Upper Extremity Function (Fine Motor, ADL) - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Upper Extremity Function (Fine Motor, ADL)" short form has 8 questions regarding the fine motor levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome. | Posted | Mean | Standard Deviation | score on a scale (40 points total) | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Secondary | Change From Baseline in Neuro-QOL. - Stigma | Stigma-Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Stigma" short form has 8 questions regarding the stigma levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome. | Posted | Mean | Standard Deviation | score on a scale (40 points total) | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Secondary | Change From Baseline in Neuro-QOL. - Social Roles | Satisfaction with Social Roles and Activities - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Satisfaction with Social Roles and Activities" short form has 8 questions regarding the satisfaction levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome. | Posted | Mean | Standard Deviation | score on a scale (40 points total) | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Secondary | Change From Baseline in Neuro-QOL. - Cognition | Cognition Function- Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Cognition Function" short form has 8 questions regarding the cognition function levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome. | Posted | Mean | Standard Deviation | score on a scale (40 points total) | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Secondary | Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16). | The Parkinson's disease fatigue scale (PFS-16) is an 16 question assessment that measures the level of fatigue in patients diagnosed with Parkinson's disease. Each question has 5 answer choices established as "strongly disagree", "disagree", "do not agree or disagree", "agree", and "strongly agree", which are scored as 1 to 5, respectively, making the total score from 16 to 80 points. Higher score represents a worse outcome. | Posted | Mean | Standard Deviation | score on a scale (80 points total) | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Secondary | Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39). | The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100. The final reported score (summary index) is calculated by averaging the 8 scaled scores. Higher score represents a worse outcome. | Posted | Mean | Standard Deviation | score on a scale (100 points total) | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Secondary | Change From Baseline in Total Visual Analog Scale | Visual Analog Scale for Pain and Muscle Spasm. The pain and muscle spasm VAS is a unidimensional measure of pain/ muscle spasm intensity, used to record patients' pain progression and muscle spasm progression, or compare pain and muscle spasm severity between patients with similar conditions. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark summed with the distance (mm) on the 10-cm line between the "no muscle spasm" anchor and the patient's mark, providing a range of scores from 0-200. A higher score indicates greater pain/spasm intensity. | Posted | Mean | Standard Deviation | score on a scale (200 points total) | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Secondary | Change From Baseline in Dosage of Carbidopa/Levodopa | Dosage of medications. | Posted | Mean | Standard Deviation | mg | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| Secondary | Change From Baseline in Vital Signs. - Oxygen Saturation. | Changes in Oxygen Saturation. | Posted | Mean | Standard Deviation | percent of oxygen | Baseline through Week 32, Follow-up at week 42 and End of Study at week 52 |
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| 0 |
| 15 |
| 1 |
| 15 |
| 15 |
| 15 |
| EG001 | Placebo | Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9). | 0 | 9 | 0 | 9 | 9 | 9 |
| Tremor | Nervous system disorders | Non-systematic Assessment |
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| Balance Difficulty | Nervous system disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Dystonia | Nervous system disorders | Non-systematic Assessment |
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| Frozen Gait | Nervous system disorders | Non-systematic Assessment |
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| Migraine | Nervous system disorders | Non-systematic Assessment |
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| Near Syncope | Nervous system disorders | Non-systematic Assessment |
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| Neuralgia | Nervous system disorders | Non-systematic Assessment |
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| Sedation | Nervous system disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Influenza-like symptoms | General disorders | Non-systematic Assessment |
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| Ankle edema | General disorders | Non-systematic Assessment |
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| Chills | General disorders | Non-systematic Assessment |
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| Drug Ineffective | General disorders | Non-systematic Assessment |
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| Feverish | General disorders | Non-systematic Assessment |
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| Muscle rigidity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Joint Pain | General disorders | Non-systematic Assessment |
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| Limb Stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Stiff Neck | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Swollen ankles | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Hazy Vision | Eye disorders | Non-systematic Assessment |
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| Cataract | Eye disorders | Non-systematic Assessment |
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| Eyelid twitching | Eye disorders | Non-systematic Assessment |
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| Eyes heavy feeling of | Eye disorders | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Muscle Strain | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | Non-systematic Assessment |
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| Mixed anxiety and depressive disorder | Psychiatric disorders | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Flushing | Vascular disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Increased salivation | Gastrointestinal disorders | Non-systematic Assessment |
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| COVID-19 virus test positive | Investigations | Non-systematic Assessment |
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| Hypercholesterolemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Kidney Stone | Renal and urinary disorders | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Eye laser surgery | Surgical and medical procedures | Non-systematic Assessment |
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Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Basophils (%) Week 52 |
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| Eosinophils (%) Week 24 |
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| Eosinophils (%) Week 52 |
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| Lymphocytes (%) Week 52 |
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| Monocytes (%) Baseline value |
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| Monocytes (%) Week 24 |
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| Monocytes (%) Week 52 |
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| Neutrophils (%) Baseline Value |
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| Neutrophils (%) Week 24 |
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| Neutrophils (%) Week 52 |
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| Platelets (10^9 cells/L) Week 52 |
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| Leukocytes (10^9 cells/L) Baseline Value |
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| Leukocytes (10^9 cells/L) Week 24 |
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| Leukocytes (10^9 cells/L) Week 52 |
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| Ery. Mean Corpuscular HGB Concentration (g/dL) Week 52 |
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| Hemoglobin (g/dL) Baseline Value |
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| Hemoglobin (g/dL) Week 24 |
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| Partial Thromboplastin Time (sec) Baseline Value |
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