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Completed

NCT Number: NCT00420134

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

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.

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Key information

Conditions

Liver Failure Cirrhosis Digestive System Diseases End Stage Liver Disease Fibrosis Hepatic Insufficiency Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Center for Gastroenterology and Liver Diseases, Tehran, Tehran Province, Iran

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

injection of progenitor of hepatocyte drived from Mesenchymal stem cell

Procedure

Primary outcomes

  1. Liver function test

  2. MELD score

Secondary outcomes

  1. Cirrhosis mortality after 6 months

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Collaborators

  • Tarbiat Modarres University

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 9, 2007
Registry last updated
Sep 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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