RecruitingPhase 2NCT05086003

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


Sponsor

Rabin Medical Center

Enrollment

20 participants

Start Date

Jan 19, 2016

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

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

Exclusion Criteria3

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

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Interventions

COMBINATION_PRODUCTCombined kidney and bone marrow transplantation

Combined kidney and bone marrow transplantation


Locations(1)

Rabin Medical Center

Petah Tikva, Israel

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NCT05086003


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