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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

January 31, 2028

Primary Completion Date

December 31, 2031

Study Completion Date

December 31, 2031

Conditions
Acute-On-Chronic Liver Failure
Interventions
DRUG

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.

DRUG

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.

OTHER

Standard Medical Treatment

All patients will receive the standard medical treatment.

Trial Locations (3)

110029

All India Institutes of Medical Sciences (AIIMS), New Delhi

110070

Institute of Liver & Biliary Sciences, New Delhi

160012

Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

All Listed Sponsors
collaborator

Indian Council of Medical Research

OTHER_GOV

lead

Institute of Liver and Biliary Sciences, India

OTHER