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Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction

Sponsor
Rabin Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05086003
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
131.4
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Combined kidney and bone marrow transplantation
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Combined kidney and bone marrow transplantationCombined kidney and bone marrow transplantation
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction Between Matched Sibling Donor-recipient Pairs
Actual Study Start Date :
Jan 19, 2016
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Kidney and bone marrow transplantation

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

Combination Product: Combined kidney and bone marrow transplantation
Combined kidney and bone marrow transplantation

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rabin Medical Center Petah-Tikva Israel 49100

Sponsors and Collaborators

  • Rabin Medical Center

Investigators

  • Principal Investigator: Moshe Yeshurun, MD, Institution of Hematology, Rabin Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
moshe yeshurun, Dr Moshe Yeshurun, Head Bone Marrow Unit, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT05086003
Other Study ID Numbers:
  • 0759-15
First Posted:
Oct 20, 2021
Last Update Posted:
Oct 28, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by moshe yeshurun, Dr Moshe Yeshurun, Head Bone Marrow Unit, Rabin Medical Center
Renal transplantation
Bone marrow transplantation
Immune tolerance
Immunosuppression

Study Results

No Results Posted as of Oct 28, 2021