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Safety Evaluation of MSC-based Therapy for Liver Cihcrosis Treatment
Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
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.
Official title: Phase 1 Clinical Trial: Evaluation of the Safety and Preliminary Efficacy of Umbilical Cord-Derived Mesenchymal Stem Cell Extracellular Vesicle Therapy in the Treatment of Liver Cirrhosis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2026-03-15
Completion Date
2026-12-31
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
Umbilical cord mesenchymal stem cell-derived extracellular vesicles
Dimedrol 20 mg will be administered intravenously 15-30 minutes prior to EV infusion. VinEV-3 will be administered at a starting dose of 2 × 10¹⁰ EV particles/kg, with dose escalation to 4 × 10¹⁰ EV particles/kg in the absence of dose-limiting toxicity or dose reduction to 1 × 10¹⁰ EV particles/kg if dose-limiting toxicity occurs. Three infusions will be given at 30 ± 5 day intervals, 3 times, with safety follow-up through 9 months after the first infusion
Locations (1)
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Vietnam