NCT05086003

Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Combined kidney and bone marrow transplantation	Combined kidney and bone marrow transplantation

Timeline

• Start date: 2016-01-19
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2021-10-20
• Last updated: 2021-10-28

Locations

1 site across 1 country: Israel