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NCT Number: NCT07472270

Safety Evaluation of MSC-based Therapy for Liver Cihcrosis Treatment

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.

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Umbilical cord mesenchymal stem cell-derived extracellular vesicles

Biological

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

Other names: UC-MSC-EV, VinEV-3

Primary outcomes

  1. Frequency and Severity of Adverse Events and Serious Adverse Events

    Time frame: 9 months from first infusion

    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.

Secondary outcomes

  1. Blood serum biochemical analysis

    Time frame: Baseline, day 1, day 30, day 31, day 60, day 61, day 90, day 180, day 270

    Assessment of changes in serum albumin (ALB), AST, ALT, GGT, ALP levels

  2. Child-Pugh score

    Time frame: Baseline, day 30, day 60, day 90, day 180, day 270

    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).

  3. MELD score

    Time frame: Baseline, day 30, day 60, day 90, day 180, day 270

    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

  4. Change in quality of life

    Time frame: Baseline, day 90, day 180, day 270

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Thanh Liem Nguyen

CONTACT

[email protected]

(+84) 98 656 50 15

Van T. Hoang

CONTACT

+84 93 644 94 81

Sponsors and collaborators

Lead sponsor

Vinmec Research Institute of Stem Cell and Gene Technology

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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