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

Summary

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.

Conditions

• Alcoholic Liver Cirrhosis

Interventions

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

Sponsors & Collaborators

• Stempeutics Research Pvt Ltd

  lead INDUSTRY

Principal Investigators

• Dr. BV Tantry, MD., DM · KMC, Mangalore

• Dr. Samir Shah, MD., DM · Breach Candy Hospital, Mumbai

• Dr. Dinesh Kini, MD., DM · Manipal Hospital, India

• Dr.Deepak N Amarapuraka, MD., DM · Bombay Hospital & Medical Research Center, Mumbai

• Dr. VA Saraswat, MD., DM · SGPGI, Kucknow

• Dr. Aejaz Habeeb, MD., DM · Centre for Liver Research & Diagnostics, Hyderabad

• Dr Uma Devi, MD · Mediciti Hospital

• Dr Sanjay Kolte Kolte, DNB., FCPS · Sahyadri Speciality Hospital

• Dr Sandeep Nijhwan Nijhwan, MD., DM · SMS Medical College and Hospital

• Dr. Nitin Pai, MD., DM · Ruby Hall clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-06-30

Primary Completion

2016-04-30

Completion

2016-04-30

Countries

• India

Study Locations