Type I diabetes mellitus is a major health problem associated with considerable morbidity, reduced life expectancy and significant health cost. Europe includes countries with the highest incidence of type I diabetes in the world. Replacement insulin therapy is currently the only life-support treatment. It is however inadequate to control diabetes in some patients (brittle diabetes). Moreover, alternatives to insulin therapy are required to improved metabolic control and to reduce morbidity and cost associated with acute and chronic complication of diabetes. Replacement of the beta cells via organ transplantation is currently the only alternative option. Transplantation of purified islets, which contain the insulin- producing beta cell, is an alternative therapy for patients with brittle diabetes. The development of a steroid-free regimen of immunosuppression, proposed by James Shapiro (Edmonton, Canada) lead to wave of interest in the field.
Although islet transplantation is a cure for type I diabetes with enormous potential there are some significant obstacles to its implementation on a large scale. These include low number of organ donors which yield islets of sufficient quantity and quality to actually transplant, the large number of islets required for successful transplantation, the few centers having the expertise to produce transplant quality islets, and the need to keep patients on immunosuppression which can compromise the patient’s ability to fight infection and tumors. Progress of these areas is hampered by the large number of variables that influence the outcome of islet transplantation and the limited number transplants that single centers can perform.
In order to progress to large clinical trials six European-based centers for human islet transplantation have established a platform (European Consortium for Islet Transplantation: ECIT) on which common protocols can be prepared and undertaken within a multicenter framework.