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

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.