Safety Evaluation of MSC-based Therapy for Liver Cihcrosis Treatment

NCT07472270 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: ISC.25.01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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.

  9 months from first infusion

Secondary Outcomes (4)

• Blood serum biochemical analysis

  Baseline, day 1, day 30, day 31, day 60, day 61, day 90, day 180, day 270

• Child-Pugh score

  Baseline, day 30, day 60, day 90, day 180, day 270

• MELD score

  Baseline, day 30, day 60, day 90, day 180, day 270

• Change in quality of life

  Baseline, day 90, day 180, day 270

Study Arms (1)

Treatment Regimen

EXPERIMENTAL

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

Biological: Umbilical cord mesenchymal stem cell-derived extracellular vesicles

Interventions

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

Also known as: UC-MSC-EV, VinEV-3

Treatment Regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vinmec Research Institute of Stem Cell and Gene Technology: lead

Study Sites (1)

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, 100000, Vietnam

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Thanh Liem Nguyen

  Vinmec Research Institute of Stem Cell and Gene Technology Hanoi, Vietnam 100000

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thanh Liem Nguyen

CONTACT

(+84) 98 656 50 15; v.liemnt@vinmec.com

Van T. Hoang

CONTACT

+84 93 644 94 81

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Intervention therapy: VinEV-3 (MSC-derived extracellular vesicles) * Premedication: diphenhydramine (Dimedrol) 20 mg i.v., 15-30 minutes before EV infusion * Route: intravenous * Dose levels: * Starting dose: 2 × 10¹⁰ EV particles/kg * Higher dose: 4 × 10¹⁰ EV particles/kg * Dose reduction to 1 × 10¹⁰ EV particles/kg in case of dose-limiting toxicity * Infusion volume: 100 mL (VinEV-3 diluted in 0.9% sodium chloride) * Infusion duration: \~60 minutes (\~1.67 mL/min) * Administration: 3 infusions, 30 ± 5 days apart * Follow-up: 3, 6, and 9 months after first infusion * Concomitant therapy: standard of care, including antiviral therapy for hepatitis B when applicable

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: March 16, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)