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Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction Between Matched Sibling Donor-recipient Pairs
Combined transplantation of kidney and bone marrow between HLA-matched sibling donor-recipient pairs to induce immune tolerance in order to enable complete discontinuation of immunosuppressive therapy without kidney rejection. Hematopoietic stem cells are collected from the donor 4 to 8 weeks before kidney transplantation, CD34 cells are enriched by positive selection and cryopreserved. The day after kidney transplantation the recipient starts conditioning therapy with thymoglobuline, total lymphoid irradiation, steroids, tacrolimus and mycophenolate mofetil. Eleven days after kidney transplantation the stem cell graft is thawed and infused to the recipient. If mixed donor chimerism is successfully maintained more than 6 months without rejection, then immunosuppression may be tapered off until complete discontinuation.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Rabin Medical Center
Petah Tikva, Israel
Start Date
January 19, 2016
Primary Completion Date
December 31, 2025
Completion Date
December 31, 2026
Last Updated
October 28, 2021
20
ESTIMATED participants
Combined kidney and bone marrow transplantation
COMBINATION_PRODUCT
Lead Sponsor
Rabin Medical Center
NCT07294183
NCT03478215
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT03504241