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

Cirrhosis 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420134
• Other study ID #: 348
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 8, 2007
• Last updated: September 15, 2009
• Start date: February 2006
• Est. completion date: June 2009

Study information

• Verified date: September 2009
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis
• End Stage Liver Disease
• Liver Cirrhosis
• Liver Failure

Intervention

Procedure:
• injection of progenitor of hepatocyte drived from Mesenchymal stem cell

Locations

Country	Name	City	State
Iran, Islamic Republic of	Research Center for Gastroenterology and Liver Diseases	Tehran
Iran, Islamic Republic of	Research center of Gastroenterology and Liver Disease	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences	Tarbiat Modarres University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver function test
Primary	MELD score
Secondary	Cirrhosis mortality after 6 months