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NCT Number: NCT05086003

Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location status: Recruiting

Location contact

Moshe Yeshurun

CONTACT

[email protected]

0526015543

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined kidney and bone marrow transplantation

Combination Product

Combined kidney and bone marrow transplantation

Primary outcomes

  1. Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation.

    Time frame: 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Liat Shargian, MD

CONTACT

[email protected]

0542394930

Moshe Yeshurun, MD

CONTACT

[email protected]

0526015543

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2025
Study completion
2026
First posted
Oct 20, 2021
Registry last updated
Oct 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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