Safety Evaluation of MSC-based Therapy for Liver Cihcrosis Treatment

Vinmec Research Institute of Stem Cell and Gene Technology

Status and phase: Not yet enrolling; Phase 1

Conditions: Liver Cirrhosis

Treatments: Biological: Umbilical cord mesenchymal stem cell-derived extracellular vesicles

Study type: Interventional

Funder types: Other

Identifiers

NCT07472270

ISC.25.01

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Treatment Regimen

Experimental group

Description:

Participants in this experimental arm will receive intravenous VinEV-3. Premedication with Dimedrol will be administered prior to infusion. VinEV-3 will be diluted in 0.9% sodium chloride to a total volume of 100 mL and infused over approximately 60 minutes. A dose-escalation design will be applied with safety-based dose adjustment. Participants will receive three infusions administered at 30 ± 5 day intervals, while continuing standard-of-care treatment. Patients will be followed for safety and clinical outcomes at 3, 6, and 9 months after the first infusion

Treatment:

Biological: Umbilical cord mesenchymal stem cell-derived extracellular vesicles