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NCT05086003 Clinical Trial

Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction

Renal Transplantation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05086003
Other study ID # 0759-15
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 19, 2016
Est. completion date December 31, 2026

Study information
Verified date October 2021
Source Rabin Medical Center
Contact Moshe Yeshurun, MD
Phone 0526015543
Email moshe.yeshurun@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• Combined kidney and bone marrow transplantation
Combined kidney and bone marrow transplantation

Locations
Country Name City State
Israel Rabin Medical Center Petah-Tikva

Sponsors (1)
Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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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