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Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction

NCT ID: NCT05086003

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-19

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Renal Transplantation

Keywords

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Renal transplantation Bone marrow transplantation Immune tolerance Immunosuppression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Combined kidney and bone marrow transplantation
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Kidney and bone marrow transplantation

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

Group Type EXPERIMENTAL

Combined kidney and bone marrow transplantation

Intervention Type COMBINATION_PRODUCT

Combined kidney and bone marrow transplantation

Interventions

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Combined kidney and bone marrow transplantation

Combined kidney and bone marrow transplantation

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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moshe yeshurun

Dr Moshe Yeshurun, Head Bone Marrow Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Moshe Yeshurun, MD

Role: PRINCIPAL_INVESTIGATOR

Institution of Hematology, Rabin Medical Center

Locations

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Rabin Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Moshe Yeshurun, MD

Role: CONTACT

Phone: 0526015543

Email: [email protected]

Liat Shargian, MD

Role: CONTACT

Phone: 0542394930

Email: [email protected]

Facility Contacts

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Moshe Yeshurun

Role: primary

Other Identifiers

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0759-15

Identifier Type: -

Identifier Source: org_study_id