Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatmen… (NCT05116540) | Clinical Trial Compass
CompletedPhase 2
Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatment of Multiple Sclerosis
United States24 participantsStarted 2021-11-24
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female participants 18 - 75 years of age.
. Study participants must have been diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS) for at least 6 months before study participation.
. Study participants must be stabilized on any MS therapy for at least 6 months prior to randomization.
. Study participants must agree not to increase or begin any Diseases Modifying Therapies for MS during participation in the clinical trial.
. Study participants must have an EDSS score between 3.0 to 6.5. (Patient must be able to walk).
. Study participants must have previously banked their mesenchymal stem cells with Hope Biosciences.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument
Timeframe: Baseline to Week 52
2
Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Timeframe: Baseline to Week 52
3
Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Timeframe: Baseline to Week 52
4
Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Timeframe: Baseline to Week 52
5
Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Timeframe: Baseline to Week 52
6
Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
. Study participants should be able to read, understand, and provide written consent.
. Before any clinical-trial-related procedures are performed, informed consent must be obtained from the participants voluntarily.
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:
Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Timeframe: Baseline to Week 52
8
Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Timeframe: Baseline to Week 52
9
Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Timeframe: Baseline to Week 52
10
Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Timeframe: Baseline to Week 52
11
Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Timeframe: Baseline to Week 52
12
Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Timeframe: Baseline to Week 52
13
Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Timeframe: Baseline to Week 52
14
Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Timeframe: Baseline to Week 52
15
Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54
Timeframe: Baseline to Week 52
16
Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54 Composite Score
Timeframe: Baseline to Week 52
17
Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54
Timeframe: Baseline to Week 52
18
Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline - Multiple Sclerosis Quality of Life (MSQOL)-54