Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction

Recruiting now · Phase 2

Conditions studied: Renal Transplantation

In brief

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.

Key facts

Study ID

NCT05086003

Run by

Rabin Medical Center

People needed

20

Starts

2016-01-19

Expected to finish

2026-12-31

Last updated by the study team

2021-10-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age older than 18 years
• Matched siblings
• No contra-indication to thymoglobuline or total lymphoid irradiation

You may not qualify if…

• Pregnant women or breast feeding
• Infection with HIV, HBV or HCV
• Previous or presnt malignancy

Where it is running

• Rabin Medical Center — Petah Tikva, Israel (enrolling)

Full record on ClinicalTrials.gov

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