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Randomized Double-Blind Efficacy and safety study of Autologous HB-adMSCs versus placebo for the treatment of Multiple Sclerosis. This study will be for 24 subjects with 6 infusions over a 52 week period. Study participants will continue their established concomitant medications during participation in this investigation.
Each eligible study subject will receive a total of 6 intravenous infusions of HB-adMSCs or placebo. Study infusions will be administered with the following regimen, Week 0, 4, 8, 16, 24, and 32. There will be one follow-up visit and end of study at week 52.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Adipose derived Mesenchymal stem cells (Autologous) |
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| Placebo | Placebo Comparator | Normal Saline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HB-adMSCs | Biological | Autologous product |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. The developers used the SF-36 as a base and added 18 questions to address MS-specific problems, including fatigue and cognitive function. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function. There is no single overall score for MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). | Baseline to Week 52 |
| Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. The developers used the SF-36 as a base and added 18 questions to address MS-specific problems, including fatigue and cognitive function. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function. There is no single overall score for MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). | Baseline to Week 52 |
| Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Cognitive Function subscale. The score ranges from 0 to 100 percent, and is 15% of the total Mental Health Composite Score. |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of Covariance (ANCOVA) Model - Total Expanded Disability Status Scale (EDSS) Scores Through Week 52 - Change From Baseline - Efficacy Analysis Set | The EDSS is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. This scale ranges from 0 to 10 in 0.5-unit increments and a higher score represents increased disability. Scoring is based on an examination by a neurologist. |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy, lactation. Women of childbearing age who are not pregnant but do not take effective contraceptive measures. *
Study participants with other types of multiple sclerosis, such as progressive relapsing, primary or secondary progressive.
Study participant has any active malignancy, including but not limited to evidence of cutaneous basal, squamous cell carcinoma, or melanoma.
Study participant has known 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 12 months before first dose of investigational product other than stem cells produced by Hope Biosciences.
The study participant has received any experimental drug within 12 months before the first dose of the investigational product. (Except for COVID-19 vaccinations)
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.
The study participant has any concurrent neurologic disease, including hereditary conditions that the principal investigator considers could interfere with the study participation. Some of these neurologic diseases could be Charcot-Marie-Tooth (CMT) or Spinocerebellar Ataxia (SCA).
Study participant has any ongoing infection, including TB, CMV, EBV, HSV, VZV, hepatitis virus, toxoplasmosis, HIV, or syphilis infections, as well as hepatitis B surface antigen positive, and or/ hepatitis C PCR positivity.
Study participant is unlikely to complete the study or adhere to the study procedures.
Study participant has a previously diagnosed psychiatric condition which in the opinion of the investigator may affect self-assessments.
Study participants 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.
Participants' life expectancy must not have been considerably limited by other comorbidities, a history of previous myelodysplasia, or hematologic illness.
1. True sexual abstinence (abstaining from sexual activity during the entire period of risk).
2. Surgery (occlusion bilateral tubal ligation, vasectomized partner). 3. Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable patch, or intravaginal). 4. Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).
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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 |
We do not plan to share Individual Participant Data at this time
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | 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 | Treatment | 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 |
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| 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 Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. The developers used the SF-36 as a base and added 18 questions to address MS-specific problems, including fatigue and cognitive function. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function. There is no single overall score for MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). | One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit. | Posted | Mean | Standard Deviation | score on a scale (100 points total) | Baseline to Week 52 |
Baseline (Week 0) through End of Study (Week 52)
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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 | Treatment | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multiple Sclerosis Relapse | Nervous system disorders | [Not specified] | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | [Not specified] | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maureen Gerwin | Hope Biosciences Research Foundation | (346) 900-0340 | maureen@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 | Sep 20, 2021 | Dec 20, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 20, 2021 | Dec 20, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Randomized, Double-Blind
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Double-Blinded Randomized Study
| Placebo | Drug | Normal Saline |
|
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| Baseline to Week 52 |
| Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Emotional Wellbeing sub-scale. The score ranges from 0 to 100 percent, and is 29% of the total Mental Health Composite Score. | Baseline to Week 52 |
| Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Health Distress sub-scale. The score ranges from 0 to 100 percent, and is 14% of the total Mental Health Composite Score and 11% of the total Physical Health Composite Score. | Baseline to Week 52 |
| Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Role Limitation/Emotional sub-scale. The score ranges from 0 to 100 percent, and is 24% of the total Mental Health Composite Score. | Baseline to Week 52 |
| Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Overall Quality of Life sub-scale. The score ranges from 0 to 100 percent, and is 18% of the total Mental Health Composite Score. | Baseline to Week 52 |
| Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Energy/Fatigue sub-scale. The score ranges from 0 to 100 percent, and is 12% of the total Physical Health Composite Score. | Baseline to Week 52 |
| Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Health Perception sub-scale. The score ranges from 0 to 100 percent, and is 17% of the total Physical Health Composite Score. | Baseline to Week 52 |
| Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Physical Function sub-scale. The score ranges from 0 to 100 percent, and is 17% of the total Physical Health Composite Score. | Baseline to Week 52 |
| Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Role Limitations - Physical sub-scale. The score ranges from 0 to 100 percent, and is 12% of the total Physical Health Composite Score. | Baseline to Week 52 |
| Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Pain subscale. The score ranges from 0 to 100 percent, and is 11% of the total Physical Health Composite Score. | Baseline to Week 52 |
| Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Social Function subscale. The score ranges from 0 to 100 percent, and is 12% of the total Physical Health Composite Score. | Baseline to Week 52 |
| Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Sexual Function subscale. The score ranges from 0 to 100 percent, and is 8% of the total Physical Health Composite Score. | Baseline to Week 52 |
| Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54 | Analysis of covariance (ANCOVA) is a statistical model that combines linear regression and ANOVA to analyze the results of different treatments. In this outcome measure, ANCOVA was used to analyze change in the physical health composite score in treatment versus placebo. The ANCOVA model was used to compare HB-adMSC patients with placebo patients on Change from Baseline to Week 52 with a fixed factor of treatment, fixed stratification factors of MS severity, age and gender, and a covariate of the baseline value for the score on the corresponding outcome measure. This model allows us to test the significance of the effects of the treatment at Week 52. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately. | Baseline to Week 52 |
| Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54 Composite Score | Analysis of covariance (ANCOVA) is a statistical model that combines linear regression and ANOVA to analyze the results of different treatments. In this outcome measure, ANCOVA was used to analyze change in the mental health composite score in treatment versus placebo. The ANCOVA model was used to compare HB-adMSC patients with placebo patients on Change from Baseline to Week 52 with a fixed factor of treatment, fixed stratification factors of MS severity, age and gender, and a covariate of the baseline value for the score on the corresponding outcome measure. This model allows us to test the significance of the effects of the treatment at Week 52. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately. | Baseline to Week 52 |
| Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54 | Bayesian analysis is a statistical method that uses probability distributions to make statistical inferences about parameters using prior information. In this outcome measure, Bayesian analysis was used to analyze change in the physical health composite score in treatment versus placebo. In this study, Bayesian analysis was used to estimate the posterior distribution and to estimate the probability of the true treatment difference of change from baseline to Week 52. A linear model for each visit was constructed to model within-subject observation covariance structures by multivariate normal (MVN) distribution in the Markov chain Monte Carlo (MCMC) procedure. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately. | Baseline to Week 52 |
| Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline - Multiple Sclerosis Quality of Life (MSQOL)-54 | Bayesian analysis is a statistical method that uses probability distributions to make statistical inferences about parameters using prior information. In this outcome measure, Bayesian analysis was used to analyze change in the mental health composite score in treatment versus placebo. In this study, Bayesian analysis was used to estimate the posterior distribution and to estimate the probability of the true treatment difference of change from baseline to Week 52. A linear model for each visit was constructed to model within-subject observation covariance structures by multivariate normal (MVN) distribution in the Markov chain Monte Carlo (MCMC) procedure. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately. | Baseline to Week 52 |
| Baseline to Week 52 |
| Analysis of Covariance (ANCOVA) Model - Change From Baseline Barthel Index Scores Through Week 52 - Efficacy Analysis Set | The Barthel index is an ordinal scale that evaluates functional independence in the domains of personal care and mobility. A total of ten variables describing activities of daily living and mobility are considered, with a higher number reflecting better capacity to operate independently. The Barthel Index assesses the level of help needed by a person on a set of ten activities of daily living (ADL) related to mobility and self-care. Score ranges from 0 points to 20 points, with lower scores indicating increased disability. | Baseline to Week 52 |
| ANCOVA Model - Change From Baseline 9-Hole Peg Test Scores - Dominant Hand Avg Time Through Week 52 | The 9-HPT is a short, standardized upper extremity exam. It measures the time taken to complete the test activity, recorded in seconds. The higher the score the worse the disability. | Baseline to Week 52 |
| Analysis of Covariance (ANCOVA) Model - Change From Baseline 9-Hole Peg Test Scores - Non-Dominant Hand Avg Time Through Week 52 | The 9-HPT is a short, standardized upper extremity exam. It measures the time taken to complete the test activity, recorded in seconds. The higher the score the worse the disability. | Baseline to Week 52 |
| Analysis of Covariance (ANCOVA) Model - Change in Patient Health Questionnaire (PHQ-9) Test Scores | The PHQ-9 is the most used depression and suicidal thoughts screening test used to monitor the severity of depression and response to treatment. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. | Baseline to Week 52 |
| Baseline Vitals Values - Height | Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline |
| Change From Baseline Vitals Values - Weight | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Week 52 |
| Change From Baseline Vitals Values - Body Mass Index | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Week 52 |
| Change From Baseline Vitals Values - Respiratory Rate | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Week 52 |
| Change From Baseline Vitals Values - Temperature | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Week 52 |
| Change From Baseline Vitals Values - Systolic Blood Pressure | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Week 52 |
| Change From Baseline Vitals Values - Diastolic Blood Pressure | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Week 52 |
| Change From Baseline Vitals Values - Pulse Rate | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Week 52 |
| Change From Baseline Vitals Values - Oxygen Saturation | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Week 52 |
| Change From Baseline Physical Examination Results - Abdomen | Change From Baseline Physical Examination Results by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Week 52 |
| Change From Baseline Physical Examination Results - Cardiovascular | Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Week 52 |
| Change From Baseline Physical Examination Results - HEENT | Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Week 52 |
| Change From Baseline Physical Examination Results - Lymph Node | Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Week 52 |
| Change From Baseline Physical Examination Results - Musculoskeletal | Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Week 52 |
| Change From Baseline Physical Examination Results - Neurological | Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Week 52 |
| Change From Baseline Physical Examination Results - Respiratory | Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Week 52 |
| Change From Baseline Physical Examination Results - Skin | Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to Week 52 |
| Laboratory Values - CBC (x10^3 Cells/uL) | Unit (x10^3 cells/uL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set | Baseline to 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 (% 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) |
| 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 (pg) | Changes from baseline in CBC laboratory values with unit of pg | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| 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 (x10^6 Cells/uL) | Changes from baseline in CBC laboratory values with unit of x10^6 cells/uL. | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| Laboratory Values - CBC (RDW) | Changes from baseline in CBC laboratory values with unit of % (RDW - Red Cell Distribution Width) | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| Laboratory Values - CMP (g/dL) | Changes from baseline in CMP laboratory values with unit of g/dL. | 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 (U/L) | Changes from baseline in CMP laboratory values with units of U/L. | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| Laboratory Values - CMP (mg/dL) | Changes from baseline in CMP laboratory values with units of mg/dL. | Baseline (Week 0), Week 24, and End of Study (Week 52) |
| Laboratory Values - CMP (mEq/L) | Changes from baseline in CMP laboratory values with units of mEq/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 (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) |
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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| Age, Customized | 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 |
|
| Baseline Weight | Mean | Standard Deviation | kilograms |
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| Baseline BMI | Mean | Standard Deviation | kg/m^2 |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Treatment | 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. |
| OG001 | 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. |
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| Primary | Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. The developers used the SF-36 as a base and added 18 questions to address MS-specific problems, including fatigue and cognitive function. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function. There is no single overall score for MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). | One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit. | Posted | Mean | Standard Deviation | score on a scale (100 points total) | Baseline to Week 52 |
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| Primary | Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Cognitive Function subscale. The score ranges from 0 to 100 percent, and is 15% of the total Mental Health Composite Score. | One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit. | Posted | Mean | Standard Deviation | score on a scale (100 points total) | Baseline to Week 52 |
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| Primary | Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Emotional Wellbeing sub-scale. The score ranges from 0 to 100 percent, and is 29% of the total Mental Health Composite Score. | One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit. | Posted | Mean | Standard Deviation | score on a scale (100 points total) | Baseline to Week 52 |
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| Primary | Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Health Distress sub-scale. The score ranges from 0 to 100 percent, and is 14% of the total Mental Health Composite Score and 11% of the total Physical Health Composite Score. | One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit. | Posted | Mean | Standard Deviation | score on a scale (100 points total) | Baseline to Week 52 |
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| Primary | Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Role Limitation/Emotional sub-scale. The score ranges from 0 to 100 percent, and is 24% of the total Mental Health Composite Score. | One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit. | Posted | Mean | Standard Deviation | score on a scale (100 points total) | Baseline to Week 52 |
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| Primary | Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Overall Quality of Life sub-scale. The score ranges from 0 to 100 percent, and is 18% of the total Mental Health Composite Score. | One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit. | Posted | Mean | Standard Deviation | score on a scale (100 points total) | Baseline to Week 52 |
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| Primary | Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Energy/Fatigue sub-scale. The score ranges from 0 to 100 percent, and is 12% of the total Physical Health Composite Score. | One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit. | Posted | Mean | Standard Deviation | score on a scale (100 points total) | Baseline to Week 52 |
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| Primary | Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Health Perception sub-scale. The score ranges from 0 to 100 percent, and is 17% of the total Physical Health Composite Score. | One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit. | Posted | Mean | Standard Deviation | score on a scale (100 points total) | Baseline to Week 52 |
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| Primary | Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Physical Function sub-scale. The score ranges from 0 to 100 percent, and is 17% of the total Physical Health Composite Score. | One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit. | Posted | Mean | Standard Deviation | score on a scale (100 points total) | Baseline to Week 52 |
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| Primary | Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Role Limitations - Physical sub-scale. The score ranges from 0 to 100 percent, and is 12% of the total Physical Health Composite Score. | One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit. | Posted | Mean | Standard Deviation | score on a scale (100 points total) | Baseline to Week 52 |
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| Primary | Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Pain subscale. The score ranges from 0 to 100 percent, and is 11% of the total Physical Health Composite Score. | One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit. | Posted | Mean | Standard Deviation | score on a scale (100 points total) | Baseline to Week 52 |
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| Primary | Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Social Function subscale. The score ranges from 0 to 100 percent, and is 12% of the total Physical Health Composite Score. | One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit. | Posted | Mean | Standard Deviation | score on a scale (100 points total) | Baseline to Week 52 |
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| Primary | Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. | The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Sexual Function subscale. The score ranges from 0 to 100 percent, and is 8% of the total Physical Health Composite Score. | One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit. | Posted | Mean | Standard Deviation | score on a scale (100 points total) | Baseline to Week 52 |
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| Primary | Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54 | Analysis of covariance (ANCOVA) is a statistical model that combines linear regression and ANOVA to analyze the results of different treatments. In this outcome measure, ANCOVA was used to analyze change in the physical health composite score in treatment versus placebo. The ANCOVA model was used to compare HB-adMSC patients with placebo patients on Change from Baseline to Week 52 with a fixed factor of treatment, fixed stratification factors of MS severity, age and gender, and a covariate of the baseline value for the score on the corresponding outcome measure. This model allows us to test the significance of the effects of the treatment at Week 52. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately. | One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit. | Posted | Mean | Standard Error | score on a scale (100 points total) | Baseline to Week 52 |
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| Primary | Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54 Composite Score | Analysis of covariance (ANCOVA) is a statistical model that combines linear regression and ANOVA to analyze the results of different treatments. In this outcome measure, ANCOVA was used to analyze change in the mental health composite score in treatment versus placebo. The ANCOVA model was used to compare HB-adMSC patients with placebo patients on Change from Baseline to Week 52 with a fixed factor of treatment, fixed stratification factors of MS severity, age and gender, and a covariate of the baseline value for the score on the corresponding outcome measure. This model allows us to test the significance of the effects of the treatment at Week 52. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately. | One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit. | Posted | Mean | Standard Error | score on a scale (100 points total) | Baseline to Week 52 |
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| Primary | Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54 | Bayesian analysis is a statistical method that uses probability distributions to make statistical inferences about parameters using prior information. In this outcome measure, Bayesian analysis was used to analyze change in the physical health composite score in treatment versus placebo. In this study, Bayesian analysis was used to estimate the posterior distribution and to estimate the probability of the true treatment difference of change from baseline to Week 52. A linear model for each visit was constructed to model within-subject observation covariance structures by multivariate normal (MVN) distribution in the Markov chain Monte Carlo (MCMC) procedure. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately. | One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit. | Posted | Mean | Standard Deviation | score on a scale (100 points total) | Baseline to Week 52 |
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| Primary | Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline - Multiple Sclerosis Quality of Life (MSQOL)-54 | Bayesian analysis is a statistical method that uses probability distributions to make statistical inferences about parameters using prior information. In this outcome measure, Bayesian analysis was used to analyze change in the mental health composite score in treatment versus placebo. In this study, Bayesian analysis was used to estimate the posterior distribution and to estimate the probability of the true treatment difference of change from baseline to Week 52. A linear model for each visit was constructed to model within-subject observation covariance structures by multivariate normal (MVN) distribution in the Markov chain Monte Carlo (MCMC) procedure. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately. | One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit. | Posted | Mean | Standard Deviation | score on a scale (100 points total) | Baseline to Week 52 |
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| Secondary | Analysis of Covariance (ANCOVA) Model - Total Expanded Disability Status Scale (EDSS) Scores Through Week 52 - Change From Baseline - Efficacy Analysis Set | The EDSS is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. This scale ranges from 0 to 10 in 0.5-unit increments and a higher score represents increased disability. Scoring is based on an examination by a neurologist. | Posted | Mean | Standard Error | score on a scale (10 points total) | Baseline to Week 52 |
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| Secondary | Analysis of Covariance (ANCOVA) Model - Change From Baseline Barthel Index Scores Through Week 52 - Efficacy Analysis Set | The Barthel index is an ordinal scale that evaluates functional independence in the domains of personal care and mobility. A total of ten variables describing activities of daily living and mobility are considered, with a higher number reflecting better capacity to operate independently. The Barthel Index assesses the level of help needed by a person on a set of ten activities of daily living (ADL) related to mobility and self-care. Score ranges from 0 points to 20 points, with lower scores indicating increased disability. | Posted | Mean | Standard Error | score on a scale (20 points total) | Baseline to Week 52 |
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| Secondary | ANCOVA Model - Change From Baseline 9-Hole Peg Test Scores - Dominant Hand Avg Time Through Week 52 | The 9-HPT is a short, standardized upper extremity exam. It measures the time taken to complete the test activity, recorded in seconds. The higher the score the worse the disability. | Posted | Mean | Standard Error | seconds | Baseline to Week 52 |
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| Secondary | Analysis of Covariance (ANCOVA) Model - Change From Baseline 9-Hole Peg Test Scores - Non-Dominant Hand Avg Time Through Week 52 | The 9-HPT is a short, standardized upper extremity exam. It measures the time taken to complete the test activity, recorded in seconds. The higher the score the worse the disability. | Posted | Mean | Standard Error | seconds | Baseline to Week 52 |
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| Secondary | Analysis of Covariance (ANCOVA) Model - Change in Patient Health Questionnaire (PHQ-9) Test Scores | The PHQ-9 is the most used depression and suicidal thoughts screening test used to monitor the severity of depression and response to treatment. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. | Posted | Mean | Standard Error | score on a scale (27 points total) | Baseline to Week 52 |
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| Secondary | Baseline Vitals Values - Height | Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | Posted | Mean | Standard Error | cm | Baseline |
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| Secondary | Change From Baseline Vitals Values - Weight | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | One patient from the treatment group was unable to attend starting at their follow-up visit (Week 42), and two patients from the Placebo group stopped attending visits starting at their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | kg | Baseline to Week 52 |
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| Secondary | Change From Baseline Vitals Values - Body Mass Index | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | One patient from the treatment group was unable to attend starting at their follow-up visit (Week 42), and two patients from the Placebo group stopped attending visits starting at their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | kg/m^2 | Baseline to Week 52 |
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| Secondary | Change From Baseline Vitals Values - Respiratory Rate | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | One patient from the treatment group was unable to attend starting at their follow-up visit (Week 42), and two patients from the Placebo group stopped attending visits starting at their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | Breaths/min | Baseline to Week 52 |
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| Secondary | Change From Baseline Vitals Values - Temperature | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | One patient from the treatment group was unable to attend starting at their follow-up visit (Week 42), and two patients from the Placebo group stopped attending visits starting at their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | degrees Celsius | Baseline to Week 52 |
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| Secondary | Change From Baseline Vitals Values - Systolic Blood Pressure | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | One patient from the treatment group was unable to attend starting at their follow-up visit (Week 42), and two patients from the Placebo group stopped attending visits starting at their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | mmHg | Baseline to Week 52 |
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| Secondary | Change From Baseline Vitals Values - Diastolic Blood Pressure | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | One patient from the treatment group was unable to attend starting at their follow-up visit (Week 42), and two patients from the Placebo group stopped attending visits starting at their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | mmHg | Baseline to Week 52 |
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| Secondary | Change From Baseline Vitals Values - Pulse Rate | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | One patient from the treatment group was unable to attend starting at their follow-up visit (Week 42), and two patients from the Placebo group stopped attending visits starting at their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | beats per minute | Baseline to Week 52 |
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| Secondary | Change From Baseline Vitals Values - Oxygen Saturation | Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set | One patient from the treatment group was unable to attend starting at their follow-up visit (Week 42), and two patients from the Placebo group stopped attending visits starting at their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | percent of oxygen | Baseline to Week 52 |
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| Secondary | Change From Baseline Physical Examination Results - Abdomen | Change From Baseline Physical Examination Results by Treatment Week - Descriptive Statistics - Safety Analysis Set | Posted | Count of Participants | Participants | Baseline to Week 52 |
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| Secondary | Change From Baseline Physical Examination Results - Cardiovascular | Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set | Posted | Count of Participants | Participants | Baseline to Week 52 |
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| Secondary | Change From Baseline Physical Examination Results - HEENT | Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set | Posted | Count of Participants | Participants | Baseline to Week 52 |
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| Secondary | Change From Baseline Physical Examination Results - Lymph Node | Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set | Posted | Count of Participants | Participants | Baseline to Week 52 |
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| Secondary | Change From Baseline Physical Examination Results - Musculoskeletal | Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set | Posted | Count of Participants | Participants | Baseline to Week 52 |
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| Secondary | Change From Baseline Physical Examination Results - Neurological | Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set | Posted | Count of Participants | Participants | Baseline to Week 52 |
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| Secondary | Change From Baseline Physical Examination Results - Respiratory | Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set | Posted | Count of Participants | Participants | Baseline to Week 52 |
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| Secondary | Change From Baseline Physical Examination Results - Skin | Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set | Posted | Count of Participants | Participants | Baseline to Week 52 |
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| Secondary | Laboratory Values - CBC (x10^3 Cells/uL) | Unit (x10^3 cells/uL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set | One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | (x10^3 cells/uL) | Baseline to Week 52 |
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| Secondary | Laboratory Values - CBC (% of WBC) | Changes from baseline in CBC laboratory values with unit of % of white blood cell count. | One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | % of white blood cell count | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Secondary | Laboratory Values - CBC (% of Total Blood Cell Count) | Changes from baseline in CBC laboratory values with unit of % of total blood cell count. | One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | % of total blood cell count | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Secondary | Laboratory Values - CBC (g/dL) | Changes from baseline in CBC laboratory values with unit of g/dL | One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | g/dL | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Secondary | Laboratory Values - CBC (pg) | Changes from baseline in CBC laboratory values with unit of pg | One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | pg | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Secondary | Laboratory Values - CBC (fL) | Changes from baseline in CBC laboratory values with unit of fL. | One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | fL | Baseline (Week 0), Week 24, and End of Study (Week 52) |
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| Secondary | Laboratory Values - CBC (x10^6 Cells/uL) | Changes from baseline in CBC laboratory values with unit of x10^6 cells/uL. | One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | x10^6 cells/uL | Baseline (Week 0), Week 24, and End of Study (Week 52) |
|
|
|
| Secondary | Laboratory Values - CBC (RDW) | Changes from baseline in CBC laboratory values with unit of % (RDW - Red Cell Distribution Width) | One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | percentage | Baseline (Week 0), Week 24, and End of Study (Week 52) |
|
|
|
| Secondary | Laboratory Values - CMP (g/dL) | Changes from baseline in CMP laboratory values with unit of g/dL. | One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | g/dL | Baseline (Week 0), Week 24, and End of Study (Week 52) |
|
|
|
| Secondary | 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) | One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | Ratio: Albumin(g/dL) to Globulin(g/dL | Baseline (Week 0), Week 24, and End of Study (Week 52) |
|
|
|
| Secondary | Laboratory Values - CMP (U/L) | Changes from baseline in CMP laboratory values with units of U/L. | One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | U/L | Baseline (Week 0), Week 24, and End of Study (Week 52) |
|
|
|
| Secondary | Laboratory Values - CMP (mg/dL) | Changes from baseline in CMP laboratory values with units of mg/dL. | One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | mg/dL | Baseline (Week 0), Week 24, and End of Study (Week 52) |
|
|
|
| Secondary | Laboratory Values - CMP (mEq/L) | Changes from baseline in CMP laboratory values with units of mEq/L. | One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | mEq/L | Baseline (Week 0), Week 24, and End of Study (Week 52) |
|
|
|
| Secondary | Laboratory Values - CMP (mL/Min/1.73m^2) | Changes from baseline in CMP laboratory values with units of mL/min/1.73m^2. | One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | mL/min/1.73m^2 | Baseline (Week 0), Week 24, and End of Study (Week 52) |
|
|
|
| Secondary | 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). | One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | Ratio:Urea nit.(mg/dL) /creatinin(mg/dL) | Baseline (Week 0), Week 24, and End of Study (Week 52) |
|
|
|
| Secondary | Laboratory Values - Coagulation Panel (Seconds) | Changes from baseline in Coagulation Panel values with units of seconds. | One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | Seconds | Baseline (Week 0), Week 24, and End of Study (Week 52) |
|
|
|
| Secondary | 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). | One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) . | Posted | Mean | Standard Error | Ratio: PT (seconds) / MNPT (seconds) | Baseline (Week 0), Week 24, and End of Study (Week 52) |
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| 10 |
| 12 |
| EG001 | 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. | 0 | 12 | 1 | 12 | 11 | 12 |
| Deep Vein Thrombosis | Vascular disorders | [Not specified] | Non-systematic Assessment |
|
| Cellulitis of arm | Infections and infestations | [Not specified] | Non-systematic Assessment |
|
| Muscle spasticity | Nervous system disorders | [Not specified] | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | [Not specified] | Non-systematic Assessment |
|
| Balance Disorder | Nervous system disorders | [Not specified] | Non-systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | [Not specified] | Non-systematic Assessment |
|
| Hyperreflexia | Nervous system disorders | [Not specified] | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | [Not specified] | Non-systematic Assessment |
|
| Multiple Sclerosis relapse | Nervous system disorders | [Not specified] | Non-systematic Assessment |
|
| Peroneal nerve palsy | Nervous system disorders | [Not specified] | Non-systematic Assessment |
|
| White matter lesion | Nervous system disorders | [Not specified] | Non-systematic Assessment |
|
| Fatigue | General disorders | [Not specified] | Non-systematic Assessment |
|
| Feeling abnormal | General disorders | [Not specified] | Non-systematic Assessment |
|
| Asthenia | General disorders | [Not specified] | Non-systematic Assessment |
|
| Chest pain | General disorders | [Not specified] | Non-systematic Assessment |
|
| Exercise tolerance decreased | General disorders | [Not specified] | Non-systematic Assessment |
|
| Feeling cold | General disorders | [Not specified] | Non-systematic Assessment |
|
| Feeling hot | General disorders | [Not specified] | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | [Not specified] | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | [Not specified] | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | [Not specified] | Non-systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | [Not specified] | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | [Not specified] | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | [Not specified] | Non-systematic Assessment |
|
| Groin abscess | Infections and infestations | [Not specified] | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | [Not specified] | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | [Not specified] | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | [Not specified] | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | [Not specified] | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | [Not specified] | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | [Not specified] | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | [Not specified] | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | [Not specified] | Non-systematic Assessment |
|
| Anger | Psychiatric disorders | [Not specified] | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | [Not specified] | Non-systematic Assessment |
|
| Mood swings | Psychiatric disorders | [Not specified] | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | [Not specified] | Non-systematic Assessment |
|
| Obstructive sleep apnea syndrome | Respiratory, thoracic and mediastinal disorders | [Not specified] | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | [Not specified] | Non-systematic Assessment |
|
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | [Not specified] | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | [Not specified] | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | [Not specified] | Non-systematic Assessment |
|
| Peripheral venous disease | Vascular disorders | [Not specified] | Non-systematic Assessment |
|
| Vernal keratoconjunctivitis | Eye disorders | [Not specified] | Non-systematic Assessment |
|
| Muscle strength abnormal | Investigations | [Not specified] | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | [Not specified] | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Infusion 3 (Week 8) |
|
|
| Infusion 5 (Week 24) |
|
|
| Follow-Up (Week 42) |
|
|
| End of Study (Week 52) |
|
|
| Infusion 3 (Week 8) |
|
|
| Infusion 5 (Week 24) |
|
|
| Follow-Up (Week 42) |
|
|
| End of Study (Week 52) |
|
|
| Infusion 3 (Week 8) |
|
|
| Infusion 5 (Week 24) |
|
|
| Follow-Up (Week 42) |
|
|
| End of Study (Week 52) |
|
|
| Infusion 3 (Week 8) |
|
|
| Infusion 5 (Week 24) |
|
|
| Follow-Up (Week 42) |
|
|
| End of Study (Week 52) |
|
|
| Infusion 3 (Week 8) |
|
|
| Infusion 5 (Week 24) |
|
|
| Follow-Up (Week 42) |
|
|
| End of Study (Week 52) |
|
|
| Infusion 3 (Week 8) |
|
|
| Infusion 5 (Week 24) |
|
|
| Follow-Up (Week 42) |
|
|
| End of Study (Week 52) |
|
|
| Infusion 3 (Week 8) |
|
|
| Infusion 5 (Week 24) |
|
|
| Follow-Up (Week 42) |
|
|
| End of Study (Week 52) |
|
|
| Infusion 3 (Week 8) |
|
|
| Infusion 5 (Week 24) |
|
|
| Follow-Up (Week 42) |
|
|
| End of Study (Week 52) |
|
|
| Infusion 3 (Week 8) |
|
|
| Infusion 5 (Week 24) |
|
|
| Follow-Up (Week 42) |
|
|
| End of Study (Week 52) |
|
|
| Infusion 3 (Week 8) |
|
|
| Infusion 5 (Week 24) |
|
|
| Follow-Up (Week 42) |
|
|
| End of Study (Week 52) |
|
|
| Infusion 3 (Week 8) |
|
|
| Infusion 5 (Week 24) |
|
|
| Follow-Up (Week 42) |
|
|
| End of Study (Week 52) |
|
|
| Infusion 3 (Week 8) |
|
|
| Infusion 5 (Week 24) |
|
|
| Follow-Up (Week 42) |
|
|
| End of Study (Week 52) |
|
|
| Infusion 3 (Week 8) |
|
|
| Infusion 5 (Week 24) |
|
|
| Follow-Up (Week 42) |
|
|
| End of Study (Week 52) |
|
|
| Infusion 2 - Week 4 |
|
|
| Infusion 3- Week 8 |
|
|
| Infusion 4- Week 16 |
|
|
| Infusion 5- Week 24 |
|
|
| Infusion 6- Week 32 |
|
|
| Follow-Up- Week 42 |
|
|
| End of Study- Week 52 |
|
|
| Infusion 2 - Week 4 |
|
|
| Infusion 3 - Week 8 |
|
|
| Infusion 4 - Week 16 |
|
|
| Infusion 5 - Week 24 |
|
|
| Infusion 6 - Week 32 |
|
|
| Follow-Up - Week 42 |
|
|
| End of Study - Week 52 |
|
|
| Infusion 2 - Week 4 |
|
|
| Infusion 3 - Week 8 |
|
|
| Infusion 4 - Week 16 |
|
|
| Infusion 5 - Week 24 |
|
|
| Infusion 6 - Week 32 |
|
|
| Follow-Up - Week 42 |
|
|
| End of Study - Week 52 |
|
|
| Infusion 2 - Week 4 |
|
|
| Infusion 3 - Week 8 |
|
|
| Infusion 4 - Week 16 |
|
|
| Infusion 5 - Week 24 |
|
|
| Infusion 6 - Week 32 |
|
|
| Follow-Up - Week 42 |
|
|
| End of Study - Week 52 |
|
|
| Infusion 2 - Week 4 |
|
|
| Infusion 3 - Week 8 |
|
|
| Infusion 4 - Week 16 |
|
|
| Infusion 5 - Week 24 |
|
|
| Infusion 6 - Week 32 |
|
|
| Follow-Up - Week 42 |
|
|
| End of Study - Week 52 |
|
|
| Infusion 2 - Week 4 |
|
|
| Infusion 3 - Week 8 |
|
|
| Infusion 4 - Week 16 |
|
|
| Infusion 5 - Week 24 |
|
|
| Infusion 6 - Week 32 |
|
|
| Follow-Up - Week 42 |
|
|
| End of Study - Week 52 |
|
|
| Infusion 2 - Week 4 |
|
|
| Infusion 3 - Week 8 |
|
|
| Infusion 4 - Week 16 |
|
|
| Infusion 5 - Week 24 |
|
|
| Infusion 6 - Week 32 |
|
|
| Follow-Up - Week 42 |
|
|
| End of Study - Week 52 |
|
|
| Infusion 2 - Week 4 |
|
|
| Infusion 3 - Week 8 |
|
|
| Infusion 4 - Week 16 |
|
|
| Infusion 5 - Week 24 |
|
|
| Infusion 6 - Week 32 |
|
|
| Follow-Up - Week 42 |
|
|
| End of Study - Week 52 |
|
|
| Not Examined (No longer in Study) |
|
| Infusion 2 - Week 4 |
|
| Infusion 3 - Week 8 |
|
| Infusion 4 - Week 16 |
|
| Infusion 5 - Week 24 |
|
| Infusion 6 - Week 32 |
|
| Follow-Up - Week 42 |
|
| End of Study - Week 52 |
|
| Not Examined (No longer in Study) |
|
| Infusion 2 - Week 4 |
|
| Infusion 3 - Week 8 |
|
| Infusion 4 - Week 16 |
|
| Infusion 5 - Week 24 |
|
| Infusion 6 - Week 32 |
|
| Follow-Up - Week 42 |
|
| End of Study - Week 52 |
|
| Not Examined (No longer in Study) |
|
| Infusion 2 - Week 4 |
|
| Infusion 3 - Week 8 |
|
| Infusion 4 - Week 16 |
|
| Infusion 5 - Week 24 |
|
| Infusion 6 - Week 32 |
|
| Follow-Up - Week 42 |
|
| End of Study - Week 52 |
|
| Not Examined (No longer in Study) |
|
| Infusion 2 - Week 4 |
|
| Infusion 3 - Week 8 |
|
| Infusion 4 - Week 16 |
|
| Infusion 5 - Week 24 |
|
| Infusion 6 - Week 32 |
|
| Follow-Up - Week 42 |
|
| End of Study - Week 52 |
|
| Not Examined (No longer in Study) |
|
| Infusion 2 - Week 4 |
|
| Infusion 3 - Week 8 |
|
| Infusion 4 - Week 16 |
|
| Infusion 5 - Week 24 |
|
| Infusion 6 - Week 32 |
|
| Follow-Up - Week 42 |
|
| End of Study - Week 52 |
|
| Not Examined (No longer in Study) |
|
| Infusion 2 - Week 4 |
|
| Infusion 3 - Week 8 |
|
| Infusion 4 - Week 16 |
|
| Infusion 5 - Week 24 |
|
| Infusion 6 - Week 32 |
|
| Follow-Up - Week 42 |
|
| End of Study - Week 52 |
|
| Not Examined (No longer in Study) |
|
| Infusion 2 - Week 4 |
|
| Infusion 3 - Week 8 |
|
| Infusion 4 - Week 16 |
|
| Infusion 5 - Week 24 |
|
| Infusion 6 - Week 32 |
|
| Follow-Up - Week 42 |
|
| End of Study - Week 52 |
|
| Not Examined (No longer in Study) |
|
| Infusion 2 - Week 4 |
|
| Infusion 3 - Week 8 |
|
| Infusion 4 - Week 16 |
|
| Infusion 5 - Week 24 |
|
| Infusion 6 - Week 32 |
|
| Follow-Up - Week 42 |
|
| End of Study - Week 52 |
|
| Absolute Basophils - Week 24 |
|
|
| Absolute Basophils - Week 52 |
|
|
| Absolute Eosinophils - Baseline |
|
|
| Absolute Eosinophils - Week 24 |
|
|
| Absolute Eosinophils - Week 52 |
|
|
| Absolute Lymphocytes - Baseline |
|
|
| Absolute Lymphocytes - Week 24 |
|
|
| Absolute Lymphocytes - Week 52 |
|
|
| Absolute Monocytes - Baseline |
|
|
| Absolute Monocytes - Week 24 |
|
|
| Absolute Monocytes - Week 52 |
|
|
| Absolute Neutrophils - Baseline |
|
|
| Absolute Neutrophils - Week 24 |
|
|
| Absolute Neutrophils - Week 52 |
|
|
| Platelet Count - Baseline |
|
|
| Platelet Count - Week 24 |
|
|
| Platelet Count - Week 52 |
|
|
| WBC - Baseline |
|
|
| WBC - Week 24 |
|
|
| WBC - Week 52 |
|
|
| Basophils - Week 24 |
|
|
| Basophils - Week 52 |
|
|
| Eosinophils - Baseline |
|
|
| Eosinophils - Week 24 |
|
|
| Eosinophils - Week 52 |
|
|
| Lymphocytes - Baseline |
|
|
| Lymphocytes - Week 24 |
|
|
| Lymphocytes - Week 52 |
|
|
| Monocytes - Baseline |
|
|
| Monocytes - Week 24 |
|
|
| Monocytes - Week 52 |
|
|
| Neutrophils - Baseline |
|
|
| Neutrophils - Week 24 |
|
|
| Neutrophils - Week 52 |
|
|
| Hematocrit - Week 24 |
|
|
| Hematocrit- Week 52 |
|
|
| Hemoglobin - Week 24 |
|
|
| Hemoglobin- Week 52 |
|
|
| MCHC - Baseline |
|
|
| MCHC - Week 24 |
|
|
| MCHC- Week 52 |
|
|
| MCH - Week 24 |
|
|
| MCH- Week 52 |
|
|
| MCV - Week 24 |
|
|
| MCV - Week 52 |
|
|
| RBC - Week 24 |
|
|
| RBC - Week 52 |
|
|
| RDW - Week 24 |
|
|
| RDW - Week 52 |
|
|
| Albumin - Week 24 |
|
|
| Albumin - Week 52 |
|
|
| Calc Globulin - Baseline |
|
|
| Calc Globulin - Week 24 |
|
|
| Calc Globulin - Week 52 |
|
|
| Protein - Baseline |
|
|
| Protein - Week 24 |
|
|
| Protein - Week 52 |
|
|
| Calc A/G - Week 24 |
|
|
| Calc A/G - Week 52 |
|
|
| Alkaline Phosphatase - Week 24 |
|
|
| Alkaline Phosphatase - Week 52 |
|
|
| ALT - Baseline |
|
|
| ALT - Week 24 |
|
|
| ALT - Week 52 |
|
|
| AST - Baseline |
|
|
| AST - Week 24 |
|
|
| AST - Week 52 |
|
|
| Bilirubin - Week 24 |
|
|
| Bilirubin - Week 52 |
|
|
| Calcium - Baseline |
|
|
| Calcium - Week 24 |
|
|
| Calcium - Week 52 |
|
|
| Creatinine - Baseline |
|
|
| Creatinine - Week 24 |
|
|
| Creatinine - Week 52 |
|
|
| BUN - Baseline |
|
|
| BUN - Week 24 |
|
|
| BUN - Week 52 |
|
|
| Glucose - Baseline |
|
|
| Glucose - Week 24 |
|
|
| Glucose - Week 52 |
|
|
| Chloride - Week 24 |
|
|
| Chloride - Week 52 |
|
|
| Carbon Dioxide - Baseline |
|
|
| Carbon Dioxide - Week 24 |
|
|
| Carbon Dioxide - Week 52 |
|
|
| Potassium - Baseline |
|
|
| Potassium - Week 24 |
|
|
| Potassium - Week 52 |
|
|
| Sodium - Baseline |
|
|
| Sodium - Week 24 |
|
|
| Sodium - Week 52 |
|
|
| Glomerular Filtration Rate (eGFR) - Week 24 |
|
|
| Glomerular Filtration Rate (eGFR) - Week 52 |
|
|
| Calc BUN/Creat - Week 24 |
|
|
| Calc BUN/Creat - Week 52 |
|
|
| Prothrombin Time (PT) - Week 24 |
|
|
| Prothrombin Time (PT) - Week 52 |
|
|
| PTT - Baseline |
|
|
| PTT - Week 24 |
|
|
| PTT - Week 52 |
|
|
| INR - Week 24 |
|
|
| INR - Week 52 |
|
|