Trial | NCT01591200  Report issue

Title

Dose Finding Study to Assess Safety and Efficacy of Stem Cells in Liver Cirrhosis
A Parallel Group Randomized Open Blinded End Point Evaluation, Multicentric, Dose Escalation, Phase -II Study Assessing the Safety and Efficacy of Intraarterial (Hepatic) Ex-vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With Alcoholic Liver Cirrhosis

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
This study will evaluate the safety and efficacy of mesenchymal stem cells in patients with cirrhosis of liver. Stem cells will be injected into the hepatic artery. Improvement in various parameters will be observed over 2 years.
Study Started
Jun 30
2012
Primary Completion
Apr 30
2016
Study Completion
Apr 30
2016
Last Update
Sep 15
2016
Estimate

Biological Allogeneic Mesenchymal Stem Cells

High dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery

Biological Allogeneic Mesenchymal Stem Cells

Intermediate dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery

Biological Allogeneic Mesenchymal Stem Cells

Low dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery

Control No Intervention

This arm will receive standard protocol of care alone

Stem cells high dose Experimental

This arm will receive high dose of Allogeneic Mesenchymal Stem Cells

Stem cells intermediate dose Experimental

This arm will receive intermediate dose of Allogeneic Mesenchymal Stem Cells

Stem cells low dose Experimental

This arm will receive low dose of Allogeneic Mesenchymal Stem Cells

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.
No Results Posted