drugset / Trial / NCT05227846
Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-1)
Phase 1
Unknown
12 enrolled
Beijing 302 Hospital
Vcanbio Cell and Gene Engineering Corp., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase 1, open label, dose escalation clinical trial of human umbilical cord-derived mesenchymal stem cells for the treatment of decompensated cirrhosis. The purpose of this study is to assess the safety of human umbilical cord-derived mesenchymal stem cells in patients with decompensated cirrhosis.
Timeline
- Start
- 2022-03-22
- Primary completion
- 2024-06-30
- Completion
- 2025-03-01
Publications
- Shi L, Zhang Z, Mei S, Wang Z, Xu Z, Yao W, Liu L, Yuan M, Pan Y, Zhu K, Liu K, Meng F, Sun J, Liu W, Xie X, Dong T, Huang L, Meng F, Fu JL, Li Y, Zhang C, Fan X, Shi M, Zhang Y, Li Y, Xie WF, Zhang P, Wang FS. Dose-escalation studies of mesenchymal stromal cell therapy for decompensated liver cirrhosis: phase Ia/Ib results and immune modulation insights. Signal Transduct Target Ther. 2025 Jul 29;10(1):238. doi: 10.1038/s41392-025-02318-4.
- Wang Z, Li T, Zhang Z, Yuan M, Shi M, Wang FS, Linghu EQ, Shi L. Human umbilical cord-derived mesenchymal stem cells for the treatment of decompensated cirrhosis (MSC-DLC-1): a dose-escalation, phase I trial protocol. BMJ Open. 2023 Dec 30;13(12):e078362. doi: 10.1136/bmjopen-2023-078362.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Human Umbilical Cord-derived Mesenchymal Stem Cells | Cell therapy | 5e+07 cells | Intravenous |
| Subject | Human Umbilical Cord-derived Mesenchymal Stem Cells | Cell therapy | 1e+08 cells | Intravenous |
| Subject | Human Umbilical Cord-derived Mesenchymal Stem Cells | Cell therapy | 1.5e+08 cells | Intravenous |
| Subject | Human Umbilical Cord-derived Mesenchymal Stem Cells | Cell therapy | 2e+08 cells | Intravenous |