Dose Finding Study to Assess Safety and Efficacy of Stem Cells in Liver Cirrhosis

Launched by STEMPEUTICS RESEARCH PVT LTD · May 1, 2012

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Eligibility criteria

• Inclusion Criteria:
• • Alcoholic cirrhotics between 18-65 years of age (diagnosed by clinical, biochemical, sonographic, radiological \[CT scan\] or histological evidence of cirrhosis and portal hypertension).
• • Evidence of decompensated liver disease at screening (e.g. Child class B or C, Child-Pugh scores of ≥7 and \<14).
• • MELD scores of at least 10 (UNOS Meld calculator).
• • Normal AFP Level
• • Hb\>10gm/dl.
• • Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study
• • Signed informed consent.
• Exclusion Criteria:
• • Patients likely to undergo liver transplantation during the duration of the study.
• • Presence of advanced hepatic encephalopathy Grades 3 \& 4 (West Haven criteria for grading of hepatic encephalopathy) at the time of screening
• • Active variceal bleed.
• • Refractory ascites.
• • Evidences of autoimmune liver disease- ANA or Anti-LKM positivity.
• • Platelet count \< 30,000/mm3.
• • Serum Sodium \<129mEq/L.
• • Serum Creatinine \> 2 mg/dl.
• • Hepatocellular carcinoma or other malignancies
• • Active infectious disease.
• • Presence of severe underlying cardiac, pulmonary or renal disease.
• • Excessive alcohol (\>30 gm of alcohol/day) use in the last 3 months before screening.
• • Positive HbSAg or antibodies to HIV or HCV.
• • Pregnancy or lactation.
• • Participation in other clinical trials.
• • Unwilling/unable to sign the informed consent.