Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction Between Matched Sibling Donor-recipient Pairs

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age older than 18 years

• Matched siblings

• No contra-indication to thymoglobuline or total lymphoid irradiation

Locations
Other Locations
Israel
Rabin Medical Center
RECRUITING
Petah Tikva
Contact Information
Primary
Moshe Yeshurun, MD
moshe.yeshurun@gmail.com
0526015543
Backup
Liat Shargian, MD
liatshr@clalit.org.il
0542394930
Time Frame
Start Date: 2016-01-19
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Kidney and bone marrow transplantation
Combined kidney and bone marrow transplantation after preparation with thymoglobuline and total lymphoid irradiation
Sponsors
Leads: Rabin Medical Center

This content was sourced from clinicaltrials.gov

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