International Trial of the Edmonton Protocol for Islet Transplantation

Islet transplantation is an evolving therapy that may be considered for patients with type 1 diabetes mellitus complicated by severe hypoglycemia or labile diabetes, provided all other attempts to stabilize glycemic control have been exhausted. This multicenter trial confirms that islet transplantation using the Edmonton protocol can successfully restore long-term endogenous production of insulin and glycemic stability in such patients, but insulin independence is usually not sustainable. Islet transplantation using the Edmonton protocol can successfully restore long-term endogenous production of insulin and glycemic stability in such patients, but insulin independence is usually not sustainable. Despite substantial improvements in insulin therapy and the care of patients with type 1 diabetes mellitus, a subgroup of patients is disabled by refractory hypoglycemia. Cell-based therapy with islet transplantation offers the possibility of improved glycemic control. The past three decades have witnessed substantial progress in islet transplantation. 1 – 3 Before the year 2000, few centers performing islet transplantation achieved high rates of sustainable insulin independence after this procedure among patients with type 1 diabetes mellitus. 1 – 3 In 2000, Shapiro et al. 4 reported their initial findings with up to a year of follow-up in seven consecutive subjects treated with glucocorticoid-free immunosuppressive . . .