Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy
Summary
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.
Description
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.
Study Design
Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Kidney Transplant
Intervention
mesenchymal stem cell
Location
Fuzhou General Hospital
Fuzhou
Fujian
China
350025
Status
Not yet recruiting
Source
Organ Transplant Institute, China
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00659620
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Mesenchymal Stem Cell Transplantation
Transfer of MESENCHYMAL STEM CELLS between individuals within the same species (TRANSPLANTATION, HOMOLOGOUS) or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS).
Bone Marrow Transplantation
The transference of BONE MARROW from one human or animal to another for a variety of purposes including HEMATOPOIETIC STEM CELL TRANSPLANTATION or MESENCHYMAL STEM CELL TRANSPLANTATION.
Mesenchymal Stem Cells
Cells that can develop into distinct mesenchymal tissue such as BONE; TENDONS; MUSCLES; ADIPOSE TISSUE; CARTILAGE; NERVE TISSUE; and BLOOD and BLOOD VESSELS.
Kidney Papillary Necrosis
A complication of kidney diseases characterized by cell death involving KIDNEY PAPILLA in the KIDNEY MEDULLA. Damages to this area may hinder the kidney to concentrate urine resulting in POLYURIA. Sloughed off necrotic tissue may block KIDNEY PELVIS or URETER. Necrosis of multiple renal papillae can lead to KIDNEY FAILURE.
Nuclear Transfer Techniques
Methods of implanting a CELL NUCLEUS from a donor cell into an enucleated acceptor cell. Often the nucleus of a somatic cell is transferred into a recipient OVUM or stem cell (STEM CELLS) with the nucleus removed. This technology may provide means to generate autologous diploid pluripotent cell for therapeutic cloning, and a model for studying NUCLEAR REPROGRAMMING in embryonic stem cells. Nuclear transfer was first accomplished with frog eggs (RANA PIPIENS) and reported in 1952.
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