Abstract
Islet transplantation can relieve glucose instability and problems with hypoglycemia while the graft is functioning. Islet transplants, though significantly improving, are still mostly done on an experimental basis. In Japan, we started the phase II clinical trial with type 1 diabetes patients for islet transplantation using both brain-dead donors and DCD to evaluate ATG induction and TNF inhibition protocol. Primary endpoints are the proportion of subjects with HbA1c<7.4% and who are free of severe hypoglycemic events one years after the first islet cell infusion. This trial would play an important role in establishing islet transplantation in Japan.