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Title:
Bone Marrow Transplantation and High Dose Post-Transplant Cyclophosphamide for Chimerism Induction and Renal Allograft Tolerance
Protocol Number:
J1368
Phase:
Pilot
Physician:
Lode Swinnen
Purpose:
Kidney transplantation is a good treatment for people with end-stage kidney disease. However, there is still much to learn about how to best care for the transplanted kidney and keep it working for a long time. Unless a person receiving a kidney from someone else takes drugs that reduce immune function, the kidney will be rejected. Those drugs must be continued life-long. �The side effects of these drugs cause many problems, including infections and cancer, and frequently shorten life. �Long term immunosuppressive medications do not entirely protect against rejection episodes. Rejection episodes can cause the long term weakening and loss of the transplanted kidney from cumulative chronic rejection effects. �The likelihood that a transplanted kidney will still be functioning at 10 years is only about 50%. Both the quality and duration of life are reduced on dialysis, and the risks of transplantation increase with subsequent transplants due to sensitization. Life expectancy after a second or third kidney transplant is even shorter. For all these reasons, tolerance of the transplanted kidney, without chronic rejection and without the need for permanent immunosuppressive drug treatment, is a highly desirable goal. If this can be achieved, it would make "one kidney for life" possible.
Eligibility:
Patients between the ages pf 18 to 65 years old who are the recipient of a first renal allograft from an HLA-haploidentical, living related donor.
Treatment:
PRIMARY OBJECTIVE The primary objective of this trial is to assess the ability of bone marrow transplantation and high dose PT/Cy to induce renal allograft tolerance and thus enable discontinuation of immunosuppressive therapy in haploidentical living related donor renal transplant recipients. SECONDARY OBJECTIVES 1.To assess the safety of the study regimen. 2.To assess whether maintenance of donor chimerism is required for sustained allograft tolerance. 3.To explore mechanistic assays which might predict successful immunosuppression withdrawal.
Population:
Adult
Last Update
08/28/2014 04:23 AM
 

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