**3. Edmonton protocol of allogeneic islet transplantation (new era)**

In 2000, the University of Alberta group published that 7 out of 7 type 1 diabetic patients became insulin independent one year after allogeneic islet transplantation (**Table 1**) [15]. Their islet transplantation protocol was named


**Table 2.**

*Immunosuppression protocol for allogeneic islet transplantation.*

the Edmonton protocol. In their clinical trial, patients received two or three islet transplantations to achieve target doses. The average islet doses were 11,547 islet equivalent (IEQ )/body weight (kg). Immunosuppression was initiated immediately before transplantation. Sirolimus and low-dose tacrolimus were used for maintenance immunosuppression. In addition, Daclizumab was given intravenously every 14 days for a total of five doses (**Table 2**). Isolated islets were not cultured and transplanted as soon as possible.

International trial of the Edmonton protocol for islet transplantation was conducted [28]. The primary endpoint was insulin independence with adequate glycemic control 1 year after the final transplantation. Several secondary endpoints including insulin independence with adequate glycemic control throughout follow-up; improved values for levels of glycated hemoglobin, the mean amplitude of glycemic excursions, and basal and stimulated blood C-peptide levels, and a reduction in the need for insulin. Nine islet transplantation centers participated. The success rate of achieving primary endpoint varies among the 9 centers. The success rates were 100% in one center, 40–80% in five centers and 0% in three centers. They concluded with the Edmonton protocol of islet transplantation, insulin independence is usually not sustainable, however, persistent islet function even without insulin independence provides protection from severe hypoglycemia and improved levels of glycated hemoglobin.

In 2005, five year follow-up after islet transplantation was published by the University of Alberta group [29]. They concluded islet transplantation can relieve glucose instability and problems with hypoglycemia. C-peptide secretion was maintained in the majority of subjects for up to 5 years, although most reverted to using insulin. Since then, islet transplantation is considered a treatment to stabilize blood glucose levels and avoid hypoglycemia, not insulin independence.
