NCT05086003 Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction
| NCT ID | NCT05086003 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Rabin Medical Center |
| Condition | Renal Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2016-01-19 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2016-01-19 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Moshe Yeshurun, MD
PRINCIPAL INVESTIGATOR
Institution of Hematology, Rabin Medical Center
Frequently Asked Questions
Who can join the NCT05086003 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Renal Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05086003 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05086003 currently recruiting?
Yes, NCT05086003 is actively recruiting participants. Contact the research team at moshe.yeshurun@gmail.com for enrollment information.
Where is the NCT05086003 trial being conducted?
This trial is being conducted at Petah Tikva, Israel.
Who is sponsoring the NCT05086003 clinical trial?
NCT05086003 is sponsored by Rabin Medical Center. The principal investigator is Moshe Yeshurun, MD at Institution of Hematology, Rabin Medical Center. The trial plans to enroll 20 participants.