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

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.