National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Evaluating Mesenchymal… (NCT07075315) | Clinical Trial Compass
Not Yet RecruitingPhase 3
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
India100 participantsStarted 2028-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ACLF patients with Model for End-Stage Liver Disease (MELD) score \>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
* 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
What they're measuring
1
90-day transplant-free survival
Timeframe: Day 90
Trial details
NCT IDNCT07075315
SponsorInstitute of Liver and Biliary Sciences, India