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

September 14, 2016 updated by: Stempeutics Research Pvt Ltd

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500063
        • Mediciti Hospital
      • Hyderabad, Andhra Pradesh, India, 500058
        • Centre for Liver Research & Diagnostics
    • Karnataka
      • Bangalore, Karnataka, India, 560017
        • Manipal Hospital
      • Mangalore, Karnataka, India, 575001
        • KMC Hospital
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Institute of liver disease, HPB surgery and transplant Global Hospitals
      • Mumbai, Maharashtra, India, 400020
        • Bombay Hospital & Medical Research Center
      • Pune, Maharashtra, India, 411001
        • Ruby Hall Clinic
      • Pune, Maharashtra, India, 411004
        • Sahyadri Speciality Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • SMS Medical College and Hospital
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226014
        • SGPGI Lucknow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
This arm will receive standard protocol of care alone
Experimental: Stem cells high dose
This arm will receive high dose of Allogeneic Mesenchymal Stem Cells
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
Experimental: Stem cells intermediate dose
This arm will receive intermediate dose of Allogeneic Mesenchymal Stem Cells
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
Experimental: Stem cells low dose
This arm will receive low dose of Allogeneic Mesenchymal Stem Cells
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 2 years
The type of adverse events, number of adverse events and proportion of patients with adverse events
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver function tests.
Time Frame: 2 years
To assess the improvement in liver function
2 years
CT scan of abdomen.
Time Frame: 2 years
To assess the improvement in liver structure
2 years
Change in MELD score
Time Frame: 2 years
To assess the clinical improvement
2 years
Improvement in quality of life as assessed by SF 36 questionnaire
Time Frame: 2 years
To assess the improvement in quality of life
2 years
Histological evaluation of liver biopsy by immunohistochemical staining for AFP, PCNA, SMA
Time Frame: 6 Months
To assess the improvement in histopathology
6 Months
Change in Child-Pugh score
Time Frame: 2 years
To assess clinical improvement
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stempeutics Research Pvt Ltd

Investigators

  • Principal Investigator: Dr. BV Tantry, MD., DM, KMC, Mangalore
  • Principal Investigator: Dr. Samir Shah, MD., DM, Breach Candy Hospital, Mumbai
  • Principal Investigator: Dr. Dinesh Kini, MD., DM, Manipal Hospital, India
  • Principal Investigator: Dr.Deepak N Amarapuraka, MD., DM, Bombay Hospital & Medical Research Center, Mumbai
  • Principal Investigator: Dr. VA Saraswat, MD., DM, SGPGI, Kucknow
  • Principal Investigator: Dr. Aejaz Habeeb, MD., DM, Centre for Liver Research & Diagnostics, Hyderabad
  • Principal Investigator: Dr Uma Devi, MD, Mediciti Hospital
  • Principal Investigator: Dr Sanjay Kolte Kolte, DNB., FCPS, Sahyadri Speciality Hospital
  • Principal Investigator: Dr Sandeep Nijhwan Nijhwan, MD., DM, SMS Medical College and Hospital
  • Principal Investigator: Dr. Nitin Pai, MD., DM, Ruby Hall Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

April 15, 2012

First Submitted That Met QC Criteria

May 1, 2012

First Posted (Estimate)

May 3, 2012

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 14, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRPL/LC/09-10/001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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