Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction

Phase 2

Recruiting

• Conditions: Renal Transplantation
• Interventions: Combination Product: Combined kidney and bone marrow transplantation

• Registration Number: NCT05086003
• Lead Sponsor: Rabin Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-19
• Status Verified: 2021-10
• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-10-07
• Study First Posted: 2021-10-20
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-10-28
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Kidney and bone marrow transplantation	Combined kidney and bone marrow transplantation	Combined kidney and bone marrow transplantation after preparation with thymoglobuline and total lymphoid irradiation

Primary Outcome Measures

Name	Time	Method
Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation.	12 months	Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation.

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petah-Tikva, Israel