Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatment of Multiple Sclerosis
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.
Timeline
- Start
- 2021-11-24
- Primary completion
- 2024-06-04
- Completion
- 2024-06-04
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry analysis (superiority test); Treatment vs Placebo; p = 0.0002; Mean Difference (Final Values) 22.121 (95% CI 12.282 to 31.959); ANCOVA reads as mixed primary results NCT05116540 ↗
registry analysis (superiority test); Treatment vs Placebo; p = 0.9905; Mean Difference (Final Values) 22.137 (95% CI 12.361 to 32.006); ANCOVA reads as mixed primary results NCT05116540 ↗
release “t he HB-adMSC group showed a statistically significant improvement from baseline in their Physical Health Composite Scores (p<0.0001)” reads as met primary endpoint hope.bio ↗
release “The HB-adMSC group also exhibited a significant improvement from baseline in their Mental Health Composite Scores (p<0.0042)” reads as met primary endpoint hope.bio ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HB-adMSCs | Cell therapy | — | Intravenous |