drugset / Trial / NCT04738981
Efficacy and Safety of UC-MSCs for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT
Phase 3
Completed
130 enrolled
Peking University People's Hospital
Southern Medical University, China · collabSun Yat-sen University · collabThird Military Medical University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Randomized, open-label, multicenter study to investigate the efficacy and safety of umbilical cord-derived mesenchymal stem cells (UC-MSC) for the treatment of steroid-resistant acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT), with a view to establishing an effective treatment protocol for steroid-resistant aGVHD.
Timeline
- Start
- 2021-02-01
- Primary completion
- 2022-05-30
- Completion
- 2023-05-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | human umbilical cord mesenchymal stem cells | Cell therapy | 1e+06 cells/kg | Intravenous |
| Background | Basiliximab | Monoclonal antibody | 20 mg | Intravenous |