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 | Not Yet Recruiting Phase 1

• 1 other identifier: ILBS-ACLF-70
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

ACLF; MSC; Liver failure

Outcome Measures

Primary Outcomes (1)

• Safety of ucMSC infusion in non-viral ACLF patients defined as proportion of patients completing the protocolized doses of MSC without major adverse effects requiring discontinuation.

  Day 28 and Day 90

Secondary Outcomes (4)

• Proportion of patients developing minor adverse effects

  Day 28 and Day 90

• Feasibility of ucMSC isolation and therapy Improvement in APASL ACLF Research Consortium (AARC) and MELD score from baseline at day 28 and day 90

  Day 28 and day 90

• Incidence of sepsis (assessed by positive culture reports)

  Day 28 and Day 90

• Incidence of renal dysfunction (evaluated by urine output and kidney function tests [KFTs])

  Day 28 and 90

Study Arms (1)

Safety and feasibility of ucMSCs therapy in non-viral ACLF (Phase-1)

EXPERIMENTAL

ACLF patients as per the definition of Asian Pacific association for the study of the liver (APASL) will be enrolled for safety and feasibility study of umbilical cord mesenchymal stem cells (ucMSCs). 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. A baseline early warning score (EWS) will be undertaken with continuous monitoring of pulse and with blood pressure checks every 5 minutes during the cell infusion and then every 15 minutes during the subsequent 2-hour observation period, then every hour for the remaining 10-hour observation period (minimum total of 12 hours observation) after cell infusion.

Drug: umbilical cord Mesenchymal Stem Cell

Interventions

umbilical cord Mesenchymal Stem Cell DRUG

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.

Safety and feasibility of ucMSCs therapy in non-viral ACLF (Phase-1)

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead
• Indian Council of Medical Research: collaborator

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure; Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Dr. Shiv Kumar Sarin, DM

  Institute of Liver & Biliary Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Anupam Kumar, PhD

CONTACT

01146300000; dr.anupamkumar.ilbs@gmail.com

Fagun Sharma, M.Sc

CONTACT

01146300000; fagun.30sharma@gmail.com

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: July 11, 2025
• First Posted: August 20, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: August 28, 2025

Record last verified: 2025-08