Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT05086003

Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction

Led by Rabin Medical Center · Updated on 2021-10-28

20

Participants Needed

1

Research Sites

571 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age older than 18 years
  • Matched siblings
  • No contra-indication to thymoglobuline or total lymphoid irradiation
Not Eligible

You will not qualify if you...

  • Pregnant women or breast feeding
  • Infection with HIV, HBV or HCV
  • Previous or presnt malignancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Rabin Medical Center

Petah Tikva, Israel, 49100

Actively Recruiting

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Research Team

M

Moshe Yeshurun, MD

CONTACT

L

Liat Shargian, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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