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

Stempeutics

Status and phase: Completed; Phase 2

Conditions: Alcoholic Liver Cirrhosis

Treatments: Biological: Allogeneic Mesenchymal Stem Cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT01591200

SRPL/LC/09-10/001

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Control

No Intervention group

Description:

This arm will receive standard protocol of care alone

Stem cells high dose

Experimental group

Description:

This arm will receive high dose of Allogeneic Mesenchymal Stem Cells

Treatment:

Biological: Allogeneic Mesenchymal Stem Cells

Biological: Allogeneic Mesenchymal Stem Cells

Biological: Allogeneic Mesenchymal Stem Cells

Stem cells intermediate dose

Experimental group

Description:

This arm will receive intermediate dose of Allogeneic Mesenchymal Stem Cells

Treatment:

Biological: Allogeneic Mesenchymal Stem Cells

Biological: Allogeneic Mesenchymal Stem Cells

Biological: Allogeneic Mesenchymal Stem Cells

Stem cells low dose

Experimental group

Description:

This arm will receive low dose of Allogeneic Mesenchymal Stem Cells

Treatment:

Biological: Allogeneic Mesenchymal Stem Cells

Biological: Allogeneic Mesenchymal Stem Cells

Biological: Allogeneic Mesenchymal Stem Cells