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

NCT07075315 · tracked via the Priya Life Science India tracker

Sponsor

Institute of Liver and Biliary Sciences, India

Phase

Phase 3

Started

2028-01

Last updated

2025-08-17

Condition(s) studied

Acute-On-Chronic Liver Failure

Investigational drug(s) / intervention(s)

Umbilical cord Mesenchymal stem cellSteroidStandard Medical Treatment

Umbilical cord Mesenchymal stem cell: ucMSC 1 million/kg will be given once a week for 4 week . 250 ml normal saline will be infused 30 minutes prior to ucMSCs infusion. The fresh ucMSCs will then be infused through IV canula peripherally over 30 minutes followed by a further 250 ml normal saline over 20-30 minutes.

Steroid: Prednisolone 40 mg once daily for 7 days as inpatients. After that Lille score will be calculated on day 7. Responders (Lille score \< 0.45) will be continued on steroids for a total of 4 weeks, followed by 2 weeks oftapering before stopping the therapy. In patients who were non responsive to steroids (Lille score \> 0.45) at day 7, steroids will be stopped at day 7 and will receive only SMT.

Standard Medical Treatment: All patients will receive the 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 mesenchymal stem cells (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) score \>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 * 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 — Day 90

Trial sites (3)

Facility	City	Region
Postgraduate Institute of Medical Education and Research (PGIMER)	Chandigarh	India
All India Institutes of Medical Sciences (AIIMS)	New Delhi	India
Institute of Liver & Biliary Sciences	New Delhi	India

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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 NCT07075315 on ClinicalTrials.gov ↗ ← All trials in India