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.
US-based ProtoKinetix has reached the midpoint of a Phase-one first-in-human clinical trial of AAGP PKX-001 treated islet cells used in conjunction with the Edmonton Protocol for the treatment of Type-one diabetes, it was reported yesterday.
"The Edmonton Protocol established the utility of human-to-human islet transplantation to provide the patient with a steady supply of insulin, in contrast with the sharp peaks and troughs of blood insulin levels experienced by many patients with diabetes who fail to achieve control using repeated injections of insulin, which is today's treatment standard," said Dr.
The breakthrough in islet transplantation began in the summer of 2000 with the reported clinical success of what since has come to be known as the Edmonton protocol. Previously, only about 10% of recipients of islet transplants ever achieved insulin independence.
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.