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
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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 |

- Liver function test
- MELD score
- Cirrhosis mortality after 6 months

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
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 |
Other Study ID Numbers: |
348 |
First Posted: | January 9, 2007 Key Record Dates |
Last Update Posted: | September 17, 2009 |
Last Verified: | September 2009 |
mesenchymal stem cell end stage liver disease Cirrhosis stem cell therapy |
Liver Cirrhosis Liver Failure End Stage Liver Disease Fibrosis |
Pathologic Processes Liver Diseases Digestive System Diseases Hepatic Insufficiency |