A Pilot study on the use of Allogeneic Mesenchymal stem cells for Liver Cirrhosis

Stempeutics Research Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年2月6日

试验速览

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•1)Alcoholic cirrhotics between 18-70 years of age (diagnosed by clinical, biochemical, sonographic or histological evidence of cirrhosis and portal hypertension). 2) Evidence of decompensated liver disease at screening (e.g. Child class B or C, Child-Pugh scores of ≥7). 3) MELD scores of at least 10 (UNOS Meld calculator).4) AFP Level < 400ng/ml.5) Hb >10gm/dl. 6) Signed informed consent.

•1)Patients likely to undergo liver transplantation during the duration of the study.2)Presence of advanced hepatic encephalopathy Grades 3 & 4 (West Haven criteria for grading of hepatic encephalopathy) at the time of screening- Annexure V.3)Active variceal bleed. 4)Refractory ascites. 5)Evidences of autoimmune liver disease- ANA or Anti-LKM positivity. 6) Platelet count < 30,000/mm3.7) Serum Sodium <129mEq/L. 8) Serum Creatinine > 2 mg/dl.9) Hepatocellular carcinoma or other malignancies 10) Active infectious disease. 11) Presence of severe underlying cardiac, pulmonary or renal disease. 12) Excessive alcohol (>30 gm of absolute alcohol/day) use in the last 3 months before screening. 13) Positive HbSAg or antibodies to HIV or HCV.14) Pregnancy or lactation. 15) Participation in other clinical trials. 16) Unwilling/unable to sign the informed consent

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