National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Evaluating Mesenchymal Stem Cell Therapy in Non-viral Acute on Chronic Liver Failure (ACLF) Patient- Phase-II Trial
NC-CHRM
1 other identifier
interventional
100
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2027
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2025
CompletedFirst Posted
Study publicly available on registry
August 20, 2025
CompletedStudy Start
First participant enrolled
January 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2031
Study Completion
Last participant's last visit for all outcomes
August 1, 2031
August 20, 2025
August 1, 2025
4.6 years
July 11, 2025
August 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
90-day transplant-free survival
90-day
Secondary Outcomes (8)
28-day and 6-month transplant free survival
28-day and 6-month
Cumulative incidence of AKI, sepsis and extrahepatic-extrarenal organ dysfunctions at day 28, day 60 and day 90.
Day 28, day 60 and day 90.
Proportion of patients achieving resolution of ACLF (complete and partial) at day 90.
Day 90
Improvement in liver severity indices MELD score by 4 points and improvement in AARC grade by 1 from baseline at 28 days, day 60 and day 90.
Day 28, Day 60 and Day 90.
Impact on liver injury and regeneration (serum and histology ) at day 28 and day 90.
Day 28 and day 90
- +3 more secondary outcomes
Study Arms (2)
Umbilical cord mesenchymal stem cell (ucMSC) and Standard medical treatment (SMT)
EXPERIMENTALPatient randomize for MSC therapy together with standard medical treatment, 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. 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. All patients will receive the standard medical treatment.
Standard Medical Treatment
ACTIVE COMPARATORPatients in the SMT group will be managed as per requirement with nutrition, lactulose, intravenous albumin, fluids, blood transfusion or antibiotics as required. Patients with hepatorenal syndrome will be treated with intravenous terlipressin or noradrenaline. Renal replacement therapy will be done for standard indications in patients with severe volume overload, metabolic acidosis, or hyperkalemia unresponsive to goal-directed SMT as described above. Mechanical ventilation and routine intensive care management will be done in patients with multiorgan failure.
Interventions
umbilical cord Mesenchymal stem cell1 million/kg will be given once a week for 4 week . 250 ml normal saline will be infused 30 minutes prior to ucMSCs infusion. All patients will receive the standard medical treatment.
Standard medical treatment
Eligibility Criteria
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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Shiv Kumar Sarin, DM
Institute of Liver & Biliary Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2025
First Posted
August 20, 2025
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
August 1, 2031
Study Completion (Estimated)
August 1, 2031
Last Updated
August 20, 2025
Record last verified: 2025-08