drugset / Trial / NCT05794425
Clinical Study of UCB Combined With UC-MSCs in the Treatment of Bone Marrow Failure Disorders
Phase 1/2
Unknown
100 enrolled
Shandong Qilu Stem Cells Engineering Co., Ltd.
Affiliated Hospital of Jining Medical University · collabAir Force Hospital of Western War Zone · collabBinzhou People's Hospital · collabChildren's Hospital Affiliated to Shandong University · collabDezhou People's Hospital · collabGansu Provincial Hospital of Traditional Chinese Medicine (TCM) · collabGansu Wuwei Tumor Hospital · collabJiangxi Province Children's Hospital · collabJining First People's Hospital · collabKaifeng Central Hospital · collabLanling People's Hospital · collabLinyi People's Hospital · collabRizhao People's Hospital · collabSecond Affiliated Hospital of Zhengzhou University · collabShandong Province Third hospital · collabShandong University of Traditional Chinese Medicine · collabShengli Oilfield Hospital · collabTaian City Central Hospital · collabThe Affiliated Hospital of Binzhou Medical College · collabThe First People' s Hospital of Yunnan Province · collabThe First People's Hospital of Jingzhou · collabThe Second Affiliated Hospital of Harbin Medical University · collabThe Second Affiliated Hospital of Shandong First Medical University · collabWeihai Central Hospital · collabWeihai Municipal Hospital · collabWuwei People's Hospital · collabYantai Ludong Hospital (Shandong Provincial Hospital Group) · collabYuncheng Institute of Hematology · collabZhengzhou Central Hospital · collabZibo Municipal Hospital · collabZigong No.1 Peoples Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The multicenter collaborative clinical study conducted a systematic clinical observation in the treatment of bone marrow failure diseases via UCB\&UC-MSCs , in order to observe its clinical efficacy and safety.
Timeline
- Start
- 2023-08-01
- Primary completion
- 2025-04
- Completion
- 2026-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclosporine | Peptide | 3 mg/kg | — |
| Subject | Cyclosporine | Peptide | 5 mg/kg | — |
| Subject | Influenza Virus Vaccine | Vaccine | 5e+07 cells | Intravenous |
| Subject | Influenza Virus Vaccine | Vaccine | 8e+07 cells | Intravenous |
| Subject | mesenchymal stem cells | Cell therapy | 5e+07 cells | Intravenous |
| Subject | mesenchymal stem cells | Cell therapy | 8e+07 cells | Intravenous |