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.
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).
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
Parallel
ucMSC and Standard medical treatment
Drugumbilical 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
Other interventionStandard medical treatment
90-day transplant-free survival
28-day and 6-month transplant free survival
Cumulative incidence of AKI, sepsis and extrahepatic-extrarenal organ dysfunctions at day 28, day 60 and day 90.
Proportion of patients achieving resolution of ACLF (complete and partial) at 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.
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Institute of Liver and Biliary Sciences, India
Lead sponsor
Indian Council of Medical Research
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
