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

This study has been completed.
Sponsor:
Collaborator:
Tarbiat Modarres University
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00420134
First received: January 8, 2007
Last updated: September 15, 2009
Last verified: September 2009
  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 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 Intervention Phase
Liver Failure
Cirrhosis
Procedure: injection of progenitor of hepatocyte drived from Mesenchymal stem cell
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Shahid 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
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Medical University
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00420134     History of Changes
Other Study ID Numbers: 348
Study First Received: January 8, 2007
Last Updated: September 15, 2009
Health Authority: Iran: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 23, 2014