Combined kidney and bone marrow transplantation for immune tolerance
Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction Between Matched Sibling Donor-recipient Pairs
This study is testing if getting a kidney and bone marrow transplant from a matched sibling can help people stop taking immune-suppressing drugs without their body rejecting the kidney.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Rabin Medical Center Academic / other |
| Locations | 1 site (Petah Tikva) |
| Trial ID | NCT05086003 on ClinicalTrials.gov |
What this trial studies
This study investigates the combined transplantation of kidney and bone marrow from HLA-matched sibling donor-recipient pairs to induce immune tolerance, allowing for the potential discontinuation of immunosuppressive therapy without kidney rejection. Hematopoietic stem cells are collected from the donor weeks prior to the kidney transplant, and after the transplant, the recipient undergoes conditioning therapy followed by the infusion of the stem cell graft. The goal is to maintain mixed donor chimerism for over six months, which may enable the tapering off of immunosuppression.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with matched sibling donors and no contraindications to the required therapies.
Not a fit: Patients who are pregnant, breastfeeding, or have infections such as HIV, HBV, or HCV, as well as those with a history of malignancy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce or eliminate the need for lifelong immunosuppressive therapy in kidney transplant recipients.
How similar studies have performed: While the approach of combining kidney and bone marrow transplantation for immune tolerance is innovative, similar studies have shown promise in the field of transplantation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Petah Tikva
- Rabin Medical Center — Petah Tikva, Israel (Recruiting)
Study contacts
- Principal investigator: Moshe Yeshurun, MD — Institution of Hematology, Rabin Medical Center
- Study coordinator: Moshe Yeshurun, MD
- Email: moshe.yeshurun@gmail.com
- Phone: 0526015543
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.