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
Single group
Umbilical cord mesenchymal stem cell-derived extracellular vesicles
Biological/VaccineDimedrol 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
Frequency and Severity of Adverse Events and Serious Adverse Events
Incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0 and dose-limiting toxicities (DLTs) when administered VinEV-3 at escalating dose levels.
Blood serum biochemical analysis
Assessment of changes in serum albumin (ALB), AST, ALT, GGT, ALP levels
Child-Pugh score
The Child-Pugh score is used to assess the prognosis of chronic liver disease, mainly cirrhosis. It consists of five clinical measures: total bilirubin, serum albumin, prothrombin time (INR), ascites, and hepatic encephalopathy. The total score ranges from 5 to 15, where higher scores indicate worse hepatic impairment (Class A: 5-6 points, Class B: 7-9 points, and Class C: 10-15 points).
MELD score
The Model for End-Stage Liver Disease (MELD) is a scoring system used to estimate the severity of chronic liver disease. The score is calculated using a formula that includes serum bilirubin, serum creatinine, and the international normalized ratio (INR). MELD scores range from 6 to 40, where a higher score indicates a more severe disease state and a higher risk of mortality
Change in quality of life
Quality of life will be assessed using the Short Form-36 (SF-36) Health Survey. The survey consists of 36 questions covering 8 health domains. Each domain is scored on a scale of 0 to 100, where higher scores indicate a better quality of life and better health status.
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