Use of Autograft Mesenchymal Stem Cells Differentiated Into Progenitor of Hepatocytes for Treatment of Patients With End-Stage Liver Disease

This study is currently recruiting participants.

Verified by Shaheed Beheshti Medical University, May 2008

Sponsors and Collaborators:	Shaheed Beheshti Medical University Tarbiat Modarres University: Department of Hematology
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00420134

Purpose

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 we try to separate mesenchymal stem cell from end stage liver disease, then these cells will be differentiated to progenitor of hepatocytes, finally , we injected these cells into portal vein under ultrasound guide. We determine the effects of injected cells in reestablishment of liver function.

Condition	Intervention	Phase
Liver Failure Cirrhosis	Procedure: injection of progenitor of hepatocyte drived from Mesenchymal stem cell	Phase I Phase II

MedlinePlus related topics: Cirrhosis Liver Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Historical Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:

Liver function test
MELD score

Secondary Outcome Measures:

Cirrhosis mortality after 6 months

Estimated Enrollment:	30
Study Start Date:	February 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420134

Contacts

Contact: Mohammad Reza Zali, MD	98-21-2241-8237 ext 102	info@rcgld.org
Contact: Pedram Kharaziha, MD	98-21-2241-8870	kharaziha@sbmu.ac.ir

Locations

Iran, Islamic Republic of
Research center of Gastroenterology and Liver Disease	Recruiting
Tehran, Iran, Islamic Republic of, 1985711151
Contact: Pedram Kharaziha, MD 98-21-2243-2525 kharaziha@sbmu.ac.ir
Research Center for Gastroenterology and Liver Diseases	Recruiting
Tehran, Iran, Islamic Republic of, 1985711151
Contact: Pedram Kharaziha, MD 98-21-2243-2525 kharaziha@sbmu.ac.ir

Sponsors and Collaborators

Shaheed Beheshti Medical University

Tarbiat Modarres University: Department of Hematology

Investigators

Study Chair:	Mohammad Reza Zali, MD	Research center of Gastroenterology and Liver Disease
Principal Investigator:	Pedram Kharaziha, MD	Research Center for Gastroenterology and Liver Diseases

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	348
Study First Received:	January 8, 2007
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00420134
Health Authority:	Iran: Ministry of Health

Keywords provided by Shaheed Beheshti Medical University:

mesenchymal stem cell
end stage liver disease
Cirrhosis
stem cell therapy

Study placed in the following topic categories:

Liver Failure
Liver Diseases
Digestive System Diseases

Fibrosis
Liver Cirrhosis
Hepatic Insufficiency

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009