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| Sponsor: | University of Tehran |
|---|---|
| Information provided by: | University of Tehran |
| ClinicalTrials.gov Identifier: | NCT00476060 |
Purpose
The standard treatment for decompensated cirrhosis is liver transplantation. But, it has several limitations. Recent animal studies suggest that bone marrow stem cell transplantation can lead to regression of liver fibrosis. The investigators have already completed the phase 1 study of bone marrow mesenchymal stem cell (MSC) transplantation in 4 patients with cirrhosis. The procedure was safe, and feasible, and led to somewhat promising results (Mohamadnejad M, et al. 2006; Submitted for publication). The aim of this study is to find efficacy of this new treatment strategy in the setting of a multicenter, randomized placebo controlled trial in 50 patients with decompensated cirrhosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Cirrhosis |
Procedure: Autologous mesenchymal stem cell transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Autologous Mesenchymal Stem Cell Transplantation in Patients With Decompensated Cirrhosis: A Randomized Placebo Controlled Trial |
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| A: Experimental |
Procedure: Autologous mesenchymal stem cell transplantation
300 million cells will e infused one time through a peripheral vein
|
| B: Placebo Comparator |
Procedure: Autologous mesenchymal stem cell transplantation
300 million cells will e infused one time through a peripheral vein
|
The standard treatment for decompensated cirrhosis is liver transplantation. But, it has several limitations including small donor pool, long waiting list, and several complications. Recent animal studies suggest that bone marrow stem cell transplantation can lead to regression of liver fibrosis. We have already completed the phase 1 study of bone marrow mesenchymal stem cell (MSC) transplantation in 4 patients with cirrhosis. The procedure was safe, and feasible, and led to somewhat promising results (Mohamadnejad M, et al. 2006; Submitted for publication). The aim of this study is to find efficacy of this new treatment strategy in the setting of a multicenter, randomized placebo controlled trial. After assignment of the written informed consent, fifty patients with decompensated cirrhosis will be enrolled, and will be randomized by block randomization into treatment or placebo arm. All the enrolled patients will be in the waiting list of liver transplantation. In the treatment arm bone marrow of the patients will be aspirated, and autologous bone marrow mesenchymal stem cells will be cultured, and then will be infused through a peripheral vein. Also, the corresponding placebo will be infused for the placebo group. The patients will be followed up for 1 year after performing the procedure.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Mehdi Mohamadnejad, M.D. | 0098 21 88012992 | mehdim@ams.ac.ir |
| Contact: Mohammad Bagheri, M.D. | 0098 21 88012992 | baghmohammad@gmail.com |
| Iran, Islamic Republic of | |
| Digestive Disease Research Center, Shariati Hospital | Recruiting |
| Tehran, Iran, Islamic Republic of, 14117-13135 | |
| Contact: Mohammad Bagheri, M.D. 0098 21 88012992 baghmohammad@gmail.com | |
| Study Chair: | Reza Malekzadeh, M.D | Digestive Disease Research Center, Medical Sciences/ University of Tehran |
| Study Chair: | Ardeshir Ghavamzadeh, M.D. | Hematology, Oncology, and BMT research center, Medical Sciences/University of Tehran |
| Principal Investigator: | Mehdi Mohamadnejad, M.D. | Digestive Disease Research Center, Medical Scineces/ University of Tehran |
| Principal Investigator: | Kamran Alimoghaddam, M.D. | Hematology, Oncology, and BMT research center, Medical Sciences/University of Tehran |
More Information
| Responsible Party: | Digestive Disease Research Center, Medical Sciences/ University of Tehran ( Reza Malekzadeh ) |
| Study ID Numbers: | DDRC85-13 |
| Study First Received: | May 16, 2007 |
| Last Updated: | February 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00476060 History of Changes |
| Health Authority: | Iran: Ministry of Health |
|
Cirrhosis Bone marrow Mesenchymal stem cell MELD score Quality of life |
|
Liver Diseases Pathologic Processes Digestive System Diseases Fibrosis Liver Cirrhosis |