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Not yet recruiting NCT07472270

Safety Evaluation of MSC-based Therapy for Liver Cihcrosis Treatment

Phase I Interventional Liver Cirrhosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Umbilical cord mesenchymal stem cell-derived extracellular vesicles.
Who it may be relevant to
Registry conditions: Liver Cirrhosis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

  • Biological Umbilical cord mesenchymal stem cell-derived extracellular vesicles
    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

Primary outcome measures

  • Frequency and Severity of Adverse Events and Serious Adverse Events [Time frame: 9 months from first infusion]
Secondary outcome measures (4)
  • Blood serum biochemical analysis [Time frame: Baseline, day 1, day 30, day 31, day 60, day 61, day 90, day 180, day 270]
  • Child-Pugh score [Time frame: Baseline, day 30, day 60, day 90, day 180, day 270]
  • MELD score [Time frame: Baseline, day 30, day 60, day 90, day 180, day 270]
  • Change in quality of life [Time frame: Baseline, day 90, day 180, day 270]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Vietnam · 1 center
  • Vinmec Research Institute of Stem Cell and Gene Technology — Hanoi

Identifiers

NCT: NCT07472270 · ISC.25.01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗