drugset / Trial / NCT07472270

Safety Evaluation of MSC-based Therapy for Liver Cihcrosis Treatment

NCT07472270 ↗

Phase 1 Not yet recruiting 12 enrolled Vinmec Research Institute of Stem Cell and Gene Technology
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

EvaluationDrugModalityDoseRoute
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

Indications