A controlled study with allogenic mesenchymal stem cells in patients with Liver Cirrhosis
- Conditions
- Health Condition 1: null- Liver Cirrhosis
- Registration Number
- CTRI/2009/091/000432
- Lead Sponsor
- Stempeutics Research Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability, assessed by adverse events. The type of AE(s), number of AE(s) and proportion of patients with AE(s)Timepoint: Baseline, 7th day, 1st month, 3rd month, 6th month, 9th month, 12th month.
- Secondary Outcome Measures
Name Time Method iver function tests. <br/ ><br>CT scan of abdomen. <br/ ><br>Histological evaluation of liver biopsy and immunohistochemical staining for AFP, PCNA and SMA. <br/ ><br>Change in MELD and Child-Pugh score- Annexure II & III. <br/ ><br>Improvement in quality of life as assessed by SF 36 questionnaireTimepoint: Baseline, 1st month, 3rd month, 6th month, 9th month, 12th month