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)

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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

Trial design

Treatments tested in this trial

  • umbilical cord Mesenchymal Stem Cell

Treatment groups

10 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Institute of Liver and Biliary Sciences, India

Lead sponsor

Indian Council of Medical Research

Collaborator