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National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Phase I Study on Safety and Efficacy of Mesenchymal Stem-Cell (MSC) Therapy in Non-Viral Acute-on-Chronic Liver Failure (ACLF)

NCT07131540 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-08-28

No results posted yet for this study

Summary

Liver disease deaths are rising, but transplants remain scarce in India. With over 100,000 needed annually and only \~2,500 performed, non-transplant options are urgently needed. Regenerative therapy, especially MSCs, shows promise but lacks validation, particularly for non-viral Acute on Chronic Liver Failure (ACLF). The proposed NC-CHRM aims to develop and validate MSC-based therapy to promote native liver regeneration and offer a safe, effective, transplant-free treatment.

Conditions

  • Acute-On-Chronic Liver Failure

Interventions

DRUG

umbilical cord Mesenchymal Stem Cell

To test the safety and tolerability of ucMSC 1 million/kg will be given intra-venously once a week for 4 week in 10 ACLF patients. 250 ml normal saline will be infused 30 minutes prior to ucMSCs infusion. The fresh ucMSCs will be taken from ILBS cGMP facility and will be infused through IV canula peripherally over 30 minutes followed by a further 250 ml normal saline over 20-30 minutes.

Sponsors & Collaborators

  • Indian Council of Medical Research

    collaborator OTHER_GOV

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Principal Investigators

  • Dr. Shiv Kumar Sarin, DM · Institute of Liver & Biliary Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2031-12-31
Completion
2031-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07131540 on ClinicalTrials.gov