National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Evaluating Mesenchymal Stem Cell Therapy in Non-viral Acute on Chronic Liver Failure (ACLF) Patient- Phase-II Trial

NCT07131306 · tracked via the Priya Life Science India tracker

Sponsor

Institute of Liver and Biliary Sciences, India

Phase

Phase 2

Started

2027-01

Last updated

2025-08-20

Condition(s) studied

Acute-On-Chronic Liver Failure

Investigational drug(s) / intervention(s)

ucMSC and Standard medical treatmentStandard medical treatment

ucMSC and Standard medical treatment: umbilical cord Mesenchymal stem cell1 million/kg will be given once a week for 4 week . 250 ml normal saline will be infused 30 minutes prior to ucMSCs infusion. All patients will receive the standard medical treatment.

Standard medical treatment: Standard medical treatment

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 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: * ACLF patients with Model for End-Stage Liver Disease(MELD)\>18 or APASL ACLF Research Consortium(AARC) grade 2 or more with (no or single extrahepatic organ dysfunction or failure having no option of liver transplant). Exclusion Criteria: * Age \<18 or \>65 yrs * Patients with active sepsis * Patients with hepatic venous outflow tract obstruction (HVOTO) or Extrahepatic portal vein obstruction (EHPVO) * Hepatocellular carcinoma (beyond Milan) or any extrahepatic malignancy * Active bleed (mucosal or variceal) or severe coagulopathy (platelets \<20,000 or INR\>4) * Patients with refractory shock requiring norepinephrine \>0.5ug/kg/min * Patients with severe Acute Respiratory Distress Syndrome (ARDS) with Pa02/Fi02 \<150 * Patients with retroviral infections * Autoimmune hepatitis * Viral etiology of liver disease * Co-existent Hepatitis B, Hepatitis C, HIV * Chronic kidney disease * Multiorgan failure or Disseminated Intravascular Coagulation (DIC) * Patients improving on standard medical treatment * Patients on immunosuppressive medications * Pregnancy or active breastfeeding * Known severe cardiopulmonary diseases (structural or valvular heart disease, coronary artery disease, coronary pulmonary disease, chronic kidney disease) * Lack of informed consent

Primary outcome measure(s)

90-day transplant-free survival — 90-day

Trial sites (1)

Facility	City	Region	Status
Institute of Liver & Biliary Sciences	New Delhi	National Capital Territory of Delhi

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National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Evaluating Mesenchymal Stem-Cell (MSC) Therapy in Non-viral Acute on Chronic Liver Failure (ACLF) Patients - Phase-III Trial Starting soon

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07131306 on ClinicalTrials.gov ↗ ← All trials in India