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NCT05116540 · ClinicalTrials.gov registry record · Phase 2
Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatment of Multiple Sclerosis
A Phase 2 study, sponsored by Hope Biosciences Research Foundation.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT05116540: Completed Phase 2 study, sponsored by Hope Biosciences Research Foundation.
NCT05116540 is a Phase 2 study that has completed, run by Hope Biosciences Research Foundation. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05116540, a Phase 2 study, has completed, sponsored by Hope Biosciences Research Foundation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study 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.
Primary Outcome
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 wel
Interventions
- DRUG Placebo
- BIOLOGICAL HB-adMSCs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-11-24 |
| Est. Completion | 2024-06-04 |
| Phase | Phase 2 |
What the finished NCT05116540 record still lists
NCT05116540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05116540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05116540 about?
NCT05116540 is a clinical study titled "Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatment of Multiple Sclerosis". 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...
What is the current status of trial NCT05116540?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2021-11-24. Estimated completion is 2024-06-04.
What interventions are being tested in trial NCT05116540?
The interventions under investigation include: Placebo (DRUG), HB-adMSCs (BIOLOGICAL).
Who is sponsoring clinical trial NCT05116540?
This trial is sponsored by Hope Biosciences Research Foundation, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05116540's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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