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RECRUITING
NCT05086003
PHASE2

Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction

Sponsor: Rabin Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction Between Matched Sibling Donor-recipient Pairs

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2016-01-19

Completion Date

2026-12-31

Last Updated

2021-10-28

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Combined kidney and bone marrow transplantation

Combined kidney and bone marrow transplantation

Locations (1)

Rabin Medical Center

Petah Tikva, Israel