Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction

Clalit Health Services

Status and phase: Enrolling; Phase 2

Conditions: Renal Transplantation

Treatments: Combination Product: Combined kidney and bone marrow transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT05086003

0759-15

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Kidney and bone marrow transplantation

Experimental group

Description:

Combined kidney and bone marrow transplantation after preparation with thymoglobuline and total lymphoid irradiation

Treatment:

Combination Product: Combined kidney and bone marrow transplantation