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Improvement of Liver Function in Liver Cirrhosis Patients After Autologous Mesenchymal Stem Cell Injection:a Phase I-II Clinical Trial

Primary Purpose

Liver Failure, Cirrhosis

Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
injection of progenitor of hepatocyte drived from Mesenchymal stem cell
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Failure focused on measuring mesenchymal stem cell, end stage liver disease, Cirrhosis, stem cell therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • MELD score of at least 10
  • Patent portal vein on color Doppler examination of the liver
  • Normal alpha-feto protein serum levels
  • Age more than 18
  • Filling inform consent by patients and first degree family members

Exclusion criteria:

  • Any evidence of hepatocellular carcinoma on liver ultrasound studies
  • Patients want to exclude from study

Sites / Locations

  • Research Center for Gastroenterology and Liver Diseases
  • Research center of Gastroenterology and Liver Disease

Outcomes

Primary Outcome Measures

Liver function test
MELD score

Secondary Outcome Measures

Cirrhosis mortality after 6 months

Full Information

First Posted
January 8, 2007
Last Updated
September 15, 2009
Sponsor
Shahid Beheshti University of Medical Sciences
Collaborators
Tarbiat Modarres University
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1. Study Identification

Unique Protocol Identification Number
NCT00420134
Brief Title
Improvement of Liver Function in Liver Cirrhosis Patients After Autologous Mesenchymal Stem Cell Injection:a Phase I-II Clinical Trial
Official Title
A Phase One/Two Clinical Trial on the Use of Autograft Mesenchymal Stem Cells Differentiated Into Progenitor of Hepatocytes for the Salvage Treatment of Patients With End-stage Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences
Collaborators
Tarbiat Modarres University

4. Oversight

5. Study Description

Brief Summary
The methods for separation of mesenchymal stem cell were established in 2001. These cells can differentiate to osteocytes, hepatocytes, chondrocytes, myocytes and etc,. In this study the investigators try to separate mesenchymal stem cell from end stage liver disease, then these cells will be differentiated to progenitor of hepatocytes, finally , the investigators injected these cells into portal vein under ultrasound guide. The investigators determine the effects of injected cells in reestablishment of liver function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Failure, Cirrhosis
Keywords
mesenchymal stem cell, end stage liver disease, Cirrhosis, stem cell therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
injection of progenitor of hepatocyte drived from Mesenchymal stem cell
Primary Outcome Measure Information:
Title
Liver function test
Title
MELD score
Secondary Outcome Measure Information:
Title
Cirrhosis mortality after 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: MELD score of at least 10 Patent portal vein on color Doppler examination of the liver Normal alpha-feto protein serum levels Age more than 18 Filling inform consent by patients and first degree family members Exclusion criteria: Any evidence of hepatocellular carcinoma on liver ultrasound studies Patients want to exclude from study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Reza Zali, MD
Organizational Affiliation
Research center of Gastroenterology and Liver Disease
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pedram Kharaziha, MD
Organizational Affiliation
Research Center for Gastroenterology and Liver Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Center for Gastroenterology and Liver Diseases
City
Tehran
ZIP/Postal Code
1985711151
Country
Iran, Islamic Republic of
Facility Name
Research center of Gastroenterology and Liver Disease
City
Tehran
ZIP/Postal Code
1985711151
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Links:
URL
http://en.sbmu.ac.ir/Subsites/GastroenterologyLiverResearch/default.aspx
Description
Related Info

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Improvement of Liver Function in Liver Cirrhosis Patients After Autologous Mesenchymal Stem Cell Injection:a Phase I-II Clinical Trial

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