Allan Kirk | Duke University School of Medicine | Durham, NC

Duke Transplant | Durham, NC

The primary objective of the TEACH study is to determine whether immune reconstitution after lymphocyte depletion in the setting of co-stimulatory blockade and systemic mesenchymal stromal cell (MSC)- derived donor antigen can promote operational tolerance in kidney transplant recipients.

TEACH is a single center, phase I, open label, dose-escalation trial in 6 adult recipients of HLA-non-identical, living donor kidney transplant. All participants will recieve induction therapy with alemtuzumab followed by maintenance therapy wth sirolimus and belatacept. Participants will then be divided into 3 MSC dosing cohorts of 2 participants each to evaluate the optimal dose of MSC for kidney transplant recipients.

Participants eligible for immunsuppression withdrawal (ISW) will undergo stepwise withdrawal of sirolimus. Participants who have successfully withdrawn from sirolimus, remained on belatacept monotherapy, and continue to be eligible for ISW will then undergo discontinuation of belatacept.

You may be eligible to participate in the TEACH study if you:

• Are 18 years of age or older
• Are a candidate for a living-donor kidney transplant
• Do not have active hepatitis B (HBV) or hepatitis C (HCV) or a history of Human Immunodeficiency Virus (HIV)