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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kidney and bone marrow transplantation | Experimental | Combined kidney and bone marrow transplantation after preparation with thymoglobuline and total lymphoid irradiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined kidney and bone marrow transplantation | Combination Product | Combined kidney and bone marrow transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moshe Yeshurun, MD | Contact | 0526015543 | moshe.yeshurun@gmail.com | |
| Liat Shargian, MD | Contact | 0542394930 | liatshr@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Moshe Yeshurun, MD | Institution of Hematology, Rabin Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center | Recruiting | Petah Tikva | 49100 | Israel |
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| ID | Term |
|---|---|
| D016026 | Bone Marrow Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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Combined kidney and bone marrow transplantation
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| D014180 |
| Transplantation |
| D013514 | Surgical Procedures, Operative |