Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Combined kidney and bone marrow transplantation.
- Who it may be relevant to
- Registry conditions: Renal Transplantation. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction Between Matched Sibling Donor-recipient Pairs
Overview
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.
Interventions
- Combination product Combined kidney and bone marrow transplantation
Combined kidney and bone marrow transplantation
Primary outcome measures
- Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation. [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Age older than 18 years
- Matched siblings
- No contra-indication to thymoglobuline or total lymphoid irradiation
Exclusion criteria
- Pregnant women or breast feeding
- Infection with HIV, HBV or HCV
- Previous or presnt malignancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Israel · 1 center
- Rabin Medical Center — Petah Tikva
Identifiers
NCT: NCT05086003 · 0759-15