drugset / Trial / NCT07299123
Phase I Clinical Study of Haplo-HSCT Combined With Hypoxic 3D-Cultured Umbilical Cord MSC for the Treatment of SAA
Phase 1/2
Enrolling by invitation
40 enrolled
Chinese PLA General Hospital
Beijing 302 Hospital · collabBeijing Friendship Hospital · collabBeijing GeniusCure Biotechnology Co., Ltd. · collabFourth Medical Center of PLA General Hospital · collabPollon Life Co., Ltd. · collabShenzhen University General Hospital · collabThe First Medical Center of Chinese PLA General Hospital · collabThe University of Hong Kong-Shenzhen Hospital · collabYan'an University Affiliated Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Efficacy and Safety of Sequential Infusion of Hypoxic 3D-Cultured Umbilical Cord Mesenchymal Stem Cells in Haploidentical Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia: A Multicenter, Randomized, Phase 1 Trial
Timeline
- Start
- 2022-08-01
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | 2D UC-MSCs | Cell therapy | 500000 cells/kg | — |
| Subject | 3D hypoxia-preconditioned UC-MSCs | Cell therapy | 500000 cells/kg | — |