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

March 28, 2024 updated by: James F. Markmann, MD, PhD, Massachusetts General Hospital

Renal Transplantation Followed By Infusion of T-Regulatory Cells Made With Belatacept Ex-Vivo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 Years
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.
60 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Dana-Farber Cancer Institute
University of Regensburg

Investigators

  • Principal Investigator: Jim Markmann, MD PhD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

March 2, 2016

Study Completion (Actual)

March 2, 2016

Study Registration Dates

First Submitted

March 13, 2014

First Submitted That Met QC Criteria

March 17, 2014

First Posted (Estimated)

March 19, 2014

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The ONE Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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