About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age older than 18 years
Matched siblings
No contra-indication to thymoglobuline or total lymphoid irradiation
Disqualifiers
Pregnant women or breast feeding
Infection with HIV, HBV or HCV
Previous or presnt malignancy
Trial design
Single group
Treatments tested in this trial
Combined kidney and bone marrow transplantation
Combination productCombined kidney and bone marrow transplantation
Treatment groups
Trial outcomes
Primary outcomes
Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation.
Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.