Health Condition 1: null- Liver Cirrhosis
Conditions
Interventions
Intervention1: Ex vivo cultured adult allogenic MSCs: Single dose of Allogenic MSCs (either 2million or 5million cells per kg body weight) given by selective cannulation of hepatic artery (Seldinger T
Sponsors
Stempeutics Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 10gm/dl. 6) Signed informed consent.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Liver function tests. CT scan of abdomen. Histological evaluation of liver biopsy and immunohistochemical staining for AFP, PCNA and SMA. Change in MELD and Child-Pugh score- Annexure II & III. Improvement in quality of life as assessed by SF 36 questionnaireTimepoint: Baseline, 1st month, 3rd month, 6th month, 9th month, 12th month | — |
Countries
India
Contacts
Public ContactJiji Abhraham
Stempeutics Research Pvt Ltd
Outcome results
None listed