Safety Evaluation of MSC-based Therapy for Liver Cihcrosis Treatment

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

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.

Inclusion Criteria:

• 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
• Written informed consent provided

Exclusion Criteria:

• Significant renal dysfunction or coagulation abnormalities
• Liver cirrhosis of unknown etiology
• Current or suspected hepatocellular carcinoma or history of malignancy
• Portal vein thrombosis
• Pregnancy, breastfeeding, or inadequate contraception
• Severe renal, respiratory, cardiovascular, infectious, autoimmune, metabolic, or neurological disorders that may interfere with study participation
• Refractory ascites at screening
• Use of known hepatotoxic medications within a clinically relevant period
• Coinfection with HIV, tuberculosis, or other causes of chronic liver disease