drugset / Trial / NCT04971980
Safety and Efficacy Study of Human Umbilical Cord-Derived Mesenchymal Stem Cells(BC-U001) for Rheumatoid Arthritis
NaSequentialOpen-labelTreatment
Summary
BC-U001 is an allogeneic fresh human umbilical cord-derived mesenchymal stem cell product, which showed therapeutic potential for rheumatoid arthritis(RA) based on its anti-inflammatory, immunomodulatory and tissue repair activities. The primary objective of this open-label, non-randomized, dose-escalation study is to evaluate the safety and tolerability of a single intravenous infusion of BC-U001 for RA patients using a 3+3 design.
Timeline
- Start
- 2021-04-12
- Primary completion
- 2023-07-10
- Completion
- 2025-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BC-U001 | Cell therapy | 0.5 cells/kg | Intravenous |
| Subject | BC-U001 | Cell therapy | 1 cells/kg | Intravenous |
| Subject | BC-U001 | Cell therapy | 1.5 cells/kg | Intravenous |