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Sponsored by: |
Fuzhou General Hospital |
Information provided by: | Organ Transplant Institute, China |
ClinicalTrials.gov Identifier: | NCT00659620 |
Mesenchymal Stem Cell (MSC) have been shown to have immunosuppressive and repairing properties. the investigators will infuse expanded MSC into patients who develop Chronic Allograft Nephropathy. The purpose of this study is to find out MSC is more effective in preventing organ rejection and maintaining kidney function.
Condition | Intervention | Phase |
Kidney Transplant Chronic Allograft Nephropathy |
Biological: mesenchymal stem cell |
Phase I Phase II |
MedlinePlus related topics: | Kidney Transplantation |
ChemIDplus related topics: | Tacrolimus Tacrolimus anhydrous |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy |
Estimated Enrollment: | 20 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
transplantation of mesenchymal stem cell
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Biological: mesenchymal stem cell
transplantation of mesenchymal stem cell
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Kidney transplantation is a common procedure in hospitals, but organ rejection and chronic nephrotoxicity are potential problems for the patient. Approximately ninety percent of the protocol biopsies of renal allografts, performed at 18 months post transplantation, show histological lesions of chronic calcineurin nephrotoxicity. Mesenchymal Stem Cell (MSC) has been shown to have immunosuppressive and repairing properties. Some patient in this study will also receive two infusions of expanded MSC. This study will evaluate the safety and effectiveness of MSC infusions in patients .
This study will last 2 years. Participants will be randomly assigned to receive either the full immunosuppressive therapy and MSC infusions (Group 1) or immunosuppressive therapy alone (Group 2). Patients will undergo MSC infusions at the start of the study on Day 0. One year post- infusions, patients will be evaluated. At Months 12 participants will undergo kidney biopsies. Blood collection will occur at regular intervals, Serum creatinine and the estimated creatinine clearance will be monthly recorded. The transplanted kidney function will be evaluated.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jianming Tan T Jianming, Professor | 008613375918000 | DOCTORTJM@YAHOO.COM |
Contact: Junqi Guo G Junqi, vicProfessor | 008613960941458 | guojunq2002@yahoo.com.cn |
China, FUJIAN | |||||
Fuzhou General Hospital | Not yet recruiting | ||||
FUZHOU, FUJIAN, China, 350025 | |||||
Contact: Jianming Tan T Jianming, professor 008613375918000 doctortjm@YAHOO.COM |
Fuzhou General Hospital |
Principal Investigator: | Jianming Tan T Jianming, professor | Fuzhou General Hospital |
Responsible Party: | FUZHOU GENERAL HOSPITAL ( FUZHOU GENERAL HOSPITAL ) |
Study ID Numbers: | fuzhough0712, fuzhough0712 |
First Received: | April 14, 2008 |
Last Updated: | April 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00659620 |
Health Authority: | China: State Food and Drug Administration; United States: Federal Government |
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