A GMP Protocol for the Manufacture of Tregs for Clinical Application.
O'Neil A., Brook M., Abdul-Wahab S., Hester J., Lombardi G., Issa F.
Infusion of regulatory T cells is a promising therapeutic strategy in organ transplantation to modulate the immune system, prevent rejection, minimize the need for pharmaceutical immunosuppression, and improve long-term transplant outcomes. Here we describe a GMP-compliant method we have used for the manufacture of ex vivo expanded autologous regulatory T cells for use in clinical trials.