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 Participants who have successfully withdrawn from sirolimus, remained on belatacept monotherapy, and continue to be eligible for ISW will then undergo discontinuation of belatacept.
About This Study
The goal of the TEACH study is to find out whether cells from the kidney donor’s bone marrow, called mesenchymal stromal cells (MSCs), will allow a kidney transplant recipient's immune system to tolerate the new kidney with less or no anti-rejection medications. MSCs will be given after the transplant recipient has recovered from the surgery and the new kidney is working. After recieving the MSCs, the anti-rejection drugs will be slowly decreased and stopped.
If, as a result of this study, kidney transplant recipients are able to have normal function of the new kidney without taking any anti-rejection medications, they will achieve what is called a state of tolerance.
Scientists will use the TEACH study to find out whether MSCs along with the anti-rejection drugs given before and after transplantation changes the way the immune system reacts to the new kidney. The study will also try to figure out which dose of MSCs works best for kidney transplant patients.