Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05086003

Enrollment

Registered

2021-10-20

Start date

2016-01-19

Completion date

2026-12-31

Last updated

2021-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplantation

Keywords

Renal transplantation, Bone marrow transplantation, Immune tolerance, Immunosuppression

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.

Interventions

COMBINATION_PRODUCTCombined kidney and bone marrow transplantation

Combined kidney and bone marrow transplantation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Combined kidney and bone marrow transplantation

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Israel

Contacts

Primary ContactMoshe Yeshurun, MD

moshe.yeshurun@gmail.com0526015543

Backup ContactLiat Shargian, MD

liatshr@clalit.org.il0542394930

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026