Infusion of T-Regulatory Cells in Kidney Transplant Recipients (The ONE Study)
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|ClinicalTrials.gov Identifier: NCT02091232|
Recruitment Status : Active, not recruiting
First Posted : March 19, 2014
Last Update Posted : March 21, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 2018|
|Estimated Study Completion Date :||May 2018|
- 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.
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02091232
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Jim Markmann, MD PhD||Massachusetts General Hospital|