drugset / Trial / NCT03158896
Evaluation of Umbilical Cord-Derived Wharton's Jelly Stem Cells for the Treatment of Acute Graft Versus Host Disease
NaSequentialOpen-labelTreatment
Summary
This study evaluates the safety and effectiveness of two different doses of umbilical cord derived, ex-vivo cultured and expanded Wharton's jelly mesenchymal stem cells (MSCTC-0010) in the treatment of acute Graft versus Host Disease (aGVHD). The first 5 participants enrolled in the study will receive a lower dose of MSCTC-0010. If none of the first 5 participants have treatment-related serious adverse events (TRSAEs) for 42 days, then the next 5 participants will receive a slightly higher dose of MSCTC-0010.
Timeline
- Start
- 2018-07-09
- Primary completion
- 2025-12-08
- Completion
- 2025-12-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MSCTC-0010 | Cell therapy | 2e+06 cells/kg | — |
| Subject | MSCTC-0010 | Cell therapy | 1e+07 cells/kg | — |