drugset / Trial / NCT07075315

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

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2028-01
Primary completion
2031-12
Completion
2031-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Prednisolone Other / unclassified 40 mg
Subject human umbilical cord mesenchymal stem cells Cell therapy 1e+06 cells/kg Intravenous

Indications