A Clinical Study to Evaluate the Safety and Efficacy of Mesenchymal Stem Cells in Liver Cirrhosis

October 8, 2013 updated by: Dr. Sachin Jamadar, Chaitanya Hospital, Pune

Role of Bone Marrow Derived Autologous Stem Cells + Human Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Liver Cirrhosis

Cirrhosis is caused by sustained liver damage over several years either by alcohol, viral infection (Hepatitis B, C), a toxic substance (for eg. drugs, excess copper or iron in the liver), or by blockage of biliary system such that the liver undergoes progressive scarring that slowly replaces all of normal liver cells.(LC) represents a late stage of progressive hepatic fibrosis characterized by distortion of the hepatic architecture and formation of regenerative nodules. For this condition of disease the liver transplantation is one of the only effective therapies available ,but due to lack of donors, surgical complications, rejection, and high cost are it's serious problems.

Presently stem cells are used to be a one of the treatment for the same. So our approach is to evaluate the safety and efficacy of mesenchymal stem cell in condition of liver cirrhosis .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study, the patients with liver cirrhosis will undergo administration of human Mesenchymal stem cell MSCs intravenously for these patients.To observe the results Liver function will be monitored by serum analysis.The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), prealbumin(PA) and albumin (ALB) will be examined at pre-transfusion, and 6th days to 1 years post-transfusion.Also the to see Improvement evaluation by MELD score ,Quality of life ,Child-Pugh score will be done .

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Contact

Study Locations

  • India
    • Maharashtra
      • Pune,, Maharashtra, India, 411009

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

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • 25 -65 Ages Eligible for Study
  • Clinical diagnosis of liver cirrhosis
  • Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.
  • Expecting lifetime is over three years
  • Ready to come all visits

Exclusion Criteria:

  • History of life threatening allergic or immune-mediated reaction
  • Positive test results for HIV and AIDS complex ,HCV , HbsAg and Syphilis
  • Malignancies
  • Sepsis
  • Vital organs failure
  • Pregnant or lactating women
  • Subject who has been transplanted recently
  • If the investigator or treating physician feels that the Subject with any disease or condition would interfere with the trial or the safety of patient

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Mesenchymal stem cell
hUMAN MESENCHYMAL STEM CELLS
Biological: Mesenchymal stem cell
Intravenous dose of Mesenchymal stem cell derived from human Bone Marrow & umbilical cord , IN 6 divided doses , at interval of 1 week .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Liver function tests
Time Frame: 6 month
1) Improvement of Liver Function tests liver functions( Albumin (ALB), Alanine aminotransferase (ALT), Aspartate Aminotransferase (AST), Prealbumin(PA), total bilirubin (TB), and direct bilirubin (DB) kidney function Blood urea nitrogen (BUN), Urea (UA), and Crea (Cr)),international normalized ratio (INR) in Liver Cirrhosis Patients
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in liver function according to Child-Pugh
Time Frame: 6 MONTH
6 MONTH
Changes in liver function according to MELD Score
Time Frame: 6 MONTH
6 MONTH
Improvement in QUALITY OF LIFE SCALE (QOL)
Time Frame: 6 month
6 month

Other Outcome Measures

Outcome Measure
Time Frame
Changes of any clinical symptoms like abdominal distension, appetite, debilitation
Time Frame: 6 month
6 month

Collaborators and Investigators

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

Sponsor

Chaitanya Hospital, Pune

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

December 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

June 12, 2013

First Submitted That Met QC Criteria

June 13, 2013

First Posted (Estimate)

June 14, 2013

Study Record Updates

Last Update Posted (Estimate)

October 9, 2013

Last Update Submitted That Met QC Criteria

October 8, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSCC/BM/2013/LS/01

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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