End Stage Renal Disease Clinical Trial
Official title:
Tolerance Induction in Living Donor Kidney Transplantation With Hematopoietic Stem Cell Transplantation
Kidney transplantation (KT) requires a life-long immune suppression (IS). It has been
well-known that long-term IS inevitably causes various complication e.g. infection,
toxicity, diabetes, osteoporosis, avascular necrosis of hip joint, cataract, acne, and
malignancies and so on. Tolerance induction showing graft function without maintenance IS
has been considered as a final solution in the transplantation recipients. Tolerance
induction can be achieved in KT recipients with donor hematopoietic stem cell
transplantation (HSCT).
In this study, adult patients (18 and more years of age) with a human leukocyte antigen
(HLA)-haplotype match donor are enrolled. Patients receive preconditioning treatment for
HSCT 1week prior to KT. Bone marrow is harvested from donor under general anesthesia at the
time of nephrectomy for transplantation in donor. Donor BM is infused immediate
post-transplantation at intensive care unit (ICU). Immunologic measurements including
microchimerism study and protocol biopsy will be followed at several time points. IS will be
tapered slowly and withdrawn over a period of several months.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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