drugset / Trial / NCT07472270
Safety Evaluation of MSC-based Therapy for Liver Cihcrosis Treatment
NaSingle-groupOpen-labelTreatment
Summary
This study Phase 1 clinical trial aimed to evaluate the safety and preliminary efficacy of intravenously administered extracellular vesicles derived from umbilical cord mesenchymal stem cells (UC-MSC-EVs; VinEV-3) in patients with liver cirrhosis. The trial uses a rolling six dose-escalation design, enrolling up to 12 adult patients (18-75 years) with Child-Pugh scores of 7-12. The results of this study are expected to provide initial clinical evidence supporting the safety and potential therapeutic role of UC-MSC-EVs as a novel cell-free treatment approach for liver cirrhosis.
Timeline
- Start
- 2026-03-15
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Umbilical cord mesenchymal stem cell-derived extracellular vesicles | Other / unclassified | 1e+10 unknown | Intravenous |
| Subject | Umbilical cord mesenchymal stem cell-derived extracellular vesicles | Other / unclassified | 2e+10 unknown | Intravenous |
| Subject | Umbilical cord mesenchymal stem cell-derived extracellular vesicles | Other / unclassified | 4e+10 unknown | Intravenous |
| Background | Dimedrol | Unknown | 20 mg | Intravenous |