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
ucMSC and Standard medical treatmentStandard medical treatment
ucMSC and Standard medical treatment: 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: Standard medical treatment
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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
* Pregnancy or active breastfeeding
* Known severe cardiopulmonary diseases (structural or valvular heart disease, coronary artery disease, coronary pulmonary disease, chronic kidney disease)
* Lack of informed consent
Primary outcome measure(s)
90-day transplant-free survival — 90-day
Trial sites (1)
Facility
City
Region
Status
Institute of Liver & Biliary Sciences
New Delhi
National Capital Territory of Delhi
More Institute of Liver and Biliary Sciences, India trials in India
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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