Kidney Transplant Clinical Trial
Official title:
Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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