Artificial pancreas is considered as the state-of-the-art treatment for type-I diabetes while islets transplantation (IT) is the only curative method. IT is associated with significant drawbacks, primarily tissue availability and mandatory use of immunosuppressive drug therapy. The first could be met by employing stem-cell-derived products or porcine islets, the second – by separating the graft from the host immune system. Using parting approach renders the graft avascular so nutrients and waste products are transferred across the membrane by diffusion only. Exercising minimally invasive surgery, encapsulated islets are implanted into an oxygen-poor subcutaneous site. Islets cells, however, are metabolically active and their functionality is oxygen-dependent.
To meet regulatory, medical and functional requests, we developed a retrievable BAP macro-device - the βAir. It includes three modules: islets, air chamber, and membrane. Gaseous oxygen is supplied to the islets from the air chamber.
We evaluated the potency of the βAir BAP to cure experimental diabetes in allogeneic small animal models for a period of six months. Xenogeneic islets were implanted into mini-swine and monkeys with remarkable results. Two clinical trials, using minimal islets dose demonstrated clear clinical advantage.
Altogether, the capacity of the technology to achieve close to normal control over blood glucose in diabetic models was demonstrated. The direction towards a commercial BAP is understood. We now present Gen2 BAP in which building materials were optimized; the one-piece device was separated into its components – the islets module and the air chamber. Clinical trials using this device will commence in two years.