A glucocorticoid-free immunosuppressive regime for pancreatic islet transplantation. It involves five doses of daclizumab over and an eight week period, sirolimus daily for three months and then tacrolimus twice daily.
While we introduced both our allotransplantation and xenotransplantation plans in this meeting, the primary focus was our near-term plan to build upon the promising results of the Edmonton Protocol studies in 2002.
Since 1999, close to 500 patients have received the cadaveric cells through variations of the Edmonton Protocol, a procedure developed in Canada for transplanting cadaveric islet cells into people with type 1 diabetes.
Shapiro, who is widely acclaimed for his development of the Edmonton Protocol, received the award for "Outstanding Scientific Achievement" from Lacy during a 2-day conference in Philadelphia, PA, December 2-3 entitled Islet Cell Transplant, Prelude to the Future.
Many clinical trials enroll patients based upon inclusion and exclusion criteria set forth in the Edmonton protocol, including individuals with severe hypoglycemia or metabolic instability and those with significant secondary complications secondary to IDDM, including retinopathy and neuropathy.