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Infusion of T-Regulatory Cells in Kidney Transplant Recipients (The ONE Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02091232
Recruitment Status : Completed
First Posted : March 19, 2014
Last Update Posted : August 20, 2020
Dana-Farber Cancer Institute
University of Regensburg
Information provided by (Responsible Party):
James F. Markmann, MD, PhD, Massachusetts General Hospital

Brief Summary:

This research study is for patients who are going to receive a kidney transplant from a living donor. After kidney transplantation, it is necessary for transplant recipients to take "immunosuppressive drugs". These drugs work by preventing the body's immune cells from attacking and "rejecting" the new kidney. Taking these drugs long-term may also cause harm to the transplanted kidney. Therefore, the transplant community is very interested in finding ways to decrease immunosuppressive drug treatment and further reduce the risk of kidney rejection. One method to do so is known as "induction of tolerance", which is when the person who receives a transplant has treatment to make their immune cells tolerant to the donor cells.

In this study, we will try to induce tolerance by mixing recipient cells and their donor's cells together with belatacept, an immunosuppressive drug. Belatacept is a protein that attaches to immune system cells, interferes with the immune response and results in tolerance induction.

After we mix the recipient cells with the donor's cells, we will sort out one particular kind of immune cell, called a regulatory T cell, and inject them back into the recipient. Regulatory T cells are the cells that are affected by induction to reduce rejection of donated organs. This method for inducing tolerance has been used in bone marrow transplantation, but this is the first time it is being done in kidney transplantation.

This study is being conducted as part of a unique collaboration of US and EU centers called The ONE Study. The ONE Study centers have agreed to work together using common protocols and procedures but with each testing their own regulatory population for safety and the ability to promote kidney survival. Sharing data among the participating sites will permit a deeper understanding of how and why some treatments might succeed while others work less well.

Condition or disease Intervention/treatment Phase
Kidney Failure, Kidney Transplant Biological: T Regulatory Cell Infusion Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Renal Transplantation Followed By Infusion of T-Regulatory Cells Made With Belatacept Ex-Vivo
Study Start Date : May 2014
Actual Primary Completion Date : March 2, 2016
Actual Study Completion Date : March 2, 2016

Resource links provided by the National Library of Medicine

Intervention Details:
  • Biological: T Regulatory Cell Infusion
    After blood is collected from the donor and recipient, the facility will sort out one particular kind of immune cell called a regulatory T cell which is strongly influenced by tolerance induction to minimize (suppress) responses to the donor cells. In this study, these regulatory T cells are the cells which will be given back to the recipient on Day 7 (+3 days) post-transplant.

Primary Outcome Measures :
  1. Safety and Feasibility of T Regulatory Cell Infusion in Renal Transplantation [ Time Frame: 2 Weeks ]
    To examine in living donor renal transplant recipients the safety and feasibility of administering T regulatory cells derived from recipient PBMC stimulated with kidney donor PBMC in the presence of costimulatory blockade with belatacept.

Secondary Outcome Measures :
  1. T-Reg Measurements [ Time Frame: 2 Years ]

    To measure the presence, potency, and specificity of Treg in the peripheral circulation of kidney transplant recipients.

    This will be done by in-vitro testing of the T-reg cell product and peripheral blood.

  2. Reduction of Immunosuppression [ Time Frame: 60 Weeks ]
    To develop preliminary information on whether administration of the Treg cell product allows a tapering of conventional maintenance immunosuppression within 60 weeks after transplantation.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Recipient Inclusion Criteria:

  • Chronic renal insufficiency necessitating kidney transplantation
  • Aged at least 18 years
  • Donor is ABO (Blood type) compatible

Key Recipient Exclusion Criteria:

  • HIV positive, EBV negative, or suffering from chronic viral hepatitis or tuberculosis
  • Previously received any tissue or organ transplant other than planned kidney graft
  • Genetically identical to the prospective organ donor at the HLA loci (0-0-0 mismatch)
  • Panel Reactive Antibodies (PRA) >20%
  • Concomitant malignancy or history of malignancy within 5 years prior to planned study entry (excluding successfully-treated non metastatic basal/squamous cell carcinoma of the skin)
  • Ongoing treatment with systemic immunosuppressive drugs at study entry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02091232

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
University of Regensburg
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Principal Investigator: Jim Markmann, MD PhD Massachusetts General Hospital
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: James F. Markmann, MD, PhD, Chief, Division of Transplant Surgery, Massachusetts General Hospital Identifier: NCT02091232    
Other Study ID Numbers: The ONE Study
First Posted: March 19, 2014    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases