Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction
- Conditions
- Renal Transplantation
- Registration Number
- NCT05086003
- Lead Sponsor
- Rabin Medical Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Age older than 18 years
- Matched siblings
- No contra-indication to thymoglobuline or total lymphoid irradiation
- Pregnant women or breast feeding
- Infection with HIV, HBV or HCV
- Previous or presnt malignancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation. 12 months Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rabin Medical Center
🇮🇱Petah-Tikva, Israel
Rabin Medical Center🇮🇱Petah-Tikva, IsraelMoshe YeshurunContact0526015543moshe.yeshurun@gmail.com