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

NCT ID: NCT00420134

Last Updated: 2009-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Failure Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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injection of progenitor of hepatocyte drived from Mesenchymal stem cell

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tarbiat Modarres University

OTHER

Sponsor Role collaborator

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Principal Investigators

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Mohammad Reza Zali, MD

Role: STUDY_CHAIR

Research center of Gastroenterology and Liver Disease

Pedram Kharaziha, MD

Role: PRINCIPAL_INVESTIGATOR

Research Center for Gastroenterology and Liver Diseases

Locations

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Research Center for Gastroenterology and Liver Diseases

Tehran, Tehran Province, Iran

Site Status

Research center of Gastroenterology and Liver Disease

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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348

Identifier Type: -

Identifier Source: org_study_id

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