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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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ClinicalTrials.gov Identifier: NCT00420134
Recruitment Status : Completed
First Posted : January 9, 2007
Last Update Posted : September 17, 2009
Sponsor:
Collaborator:
Tarbiat Modarres University
Information provided by:
Shahid Beheshti University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Liver Failure Cirrhosis Procedure: injection of progenitor of hepatocyte drived from Mesenchymal stem cell Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
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 Start Date : February 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : June 2009

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Primary Outcome Measures :
  1. Liver function test
  2. MELD score

Secondary Outcome Measures :
  1. Cirrhosis mortality after 6 months


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420134


Locations
Iran, Islamic Republic of
Research Center for Gastroenterology and Liver Diseases
Tehran, Iran, Islamic Republic of, 1985711151
Research center of Gastroenterology and Liver Disease
Tehran, Iran, Islamic Republic of, 1985711151
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Tarbiat Modarres University
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

ClinicalTrials.gov Identifier: NCT00420134     History of Changes
Other Study ID Numbers: 348
First Posted: January 9, 2007    Key Record Dates
Last Update Posted: September 17, 2009
Last Verified: September 2009

Keywords provided by Shahid Beheshti University of Medical Sciences:
mesenchymal stem cell
end stage liver disease
Cirrhosis
stem cell therapy

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Liver Failure
End Stage Liver Disease
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hepatic Insufficiency