Umbilical Cord-derived Mesenchymal Stem Cell Infusion in the Management of Adult Liver Cirrhosis

NCT05331872 | Completed Phase 1

• 1 other identifier: ISC.19.29
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I, open label, single arm trial using UC-MSCs to treat patients with liver cirrhosis that includes 20 patients. The primary outcome measure will be change in MELD score at 3, 6, and 12 months after UC-MSC transplantation from baseline. The safety is assessed by frequency and severity of the adverse event or serious adverse event associated with stem cell injection. This study could reconfirm the efficacy of stem cell transplantation for liver cirrhosis and would open a novel cell therapy for the treatment of adult liver cirrhosis.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Number of Adverse events and serious adverse events (AEs or SAEs)

  To assess safety: the number of AEs or SAEs during and after allogenic umbilical cord-mesenchymal stem cells (UC-MSCs) infusion

  up to the 12-month period following the first UC-MSCs infusion

Secondary Outcomes (2)

• Change of liver function through the Model for End Stage Liver Disease (MELD) score

  3 months, 6 months, 12 months after the UC-MSCs infusion

• Change in health-related quality of life using Chronic Liver Disease Questionnaire - (CLDQ)

  3 months, 6 months, 12 months after the UC-MSCs infusion

Study Arms (1)

human umbilical cord-derived mesenchymal stem cell transplantation for patients with liver cirrhosis

EXPERIMENTAL

Umbilical cords from healthy donor are processed with 24 hours after vaginal delivery. The cords are delivered in a sterilized jar the laboratory to process. After washing in PBS to remove any contaminating blood, the cord is cut into small pieces. The pieces are minced and digested by enzyme. The UC-MSCs is cultured and expanded using commercially available serum-free and xeno-free medium at 37°C in a humidified atmosphere with 5% CO2. The UC-MSCs is suspended in 15 ml of saline buffer

Biological: Human umbilical cord-derived mesenchymal stem cell infusion

Interventions

Human umbilical cord-derived mesenchymal stem cell infusion BIOLOGICAL

Human umbilical cord-derived mesenchymal stem cell infusion in the management of adult liver cirrhosis

human umbilical cord-derived mesenchymal stem cell transplantation for patients with liver cirrhosis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 70 years old.
• Patients diagnosed of liver cirrhosis: splenomegaly, elevated hepatic enzymes and/or esophageal varices detected by endoscopy, or liver biopsy demonstrated liver cirrhosis
• Be willing to complete the study and sign the consent form.

You may not qualify if:

• Younger than 18 or older than 70 years old
• Recent infection
• Patients with history of chronic diseases such as cancer, chronic hepatitis, chronic kidney disease.
• Any clinically significant blood coagulation disorder(s)

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, 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

• Liem Nguyen, PHD

  Vinmec Research Institute of Stem Cell and Gene Technology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 18, 2022
• Study Start: January 1, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)