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.
Liver cirrhosis due to alcohol-related liver disease or chronic hepatitis B or C
Child-Pugh score 7-12
Alcohol-related cirrhosis: abstinent from alcohol ≥ 3 months
HBV/HCV-related cirrhosis: viral disease controlled according to standard clinical criteria
Significant renal dysfunction or coagulation abnormalities
Liver cirrhosis of unknown etiology
Current or suspected hepatocellular carcinoma or history of malignancy
Portal vein thrombosis