R&D PARTNER

R & D Partner

Research & Development Partner: University of Perugia, Italy

The laboratory at the University of Perugia was founded in 1987 by Dr. Riccardo Calafiore and his coworkers within the Department of Internal Medicine of the School of Medicine. The Laboratory pioneered studies with micro-encapsulation of pancreatic islets and other live cells, using natural chemical polymers, extracted from marine brown seaweeds (sodium alginate).

Throughout the past two decades, the Lab has developed original methods to ultra purify the raw alginate powder, turning it into “clinical grade” alginate suitable for human use, or adjusting the shape and size of alginate-based microcapsules.

Professor Calafiore has significantly advanced encapsulation procedures, and applied them to diabetes. Human islet cells were encapsulated and implanted into four diabetic patients by Professor Calafiore and colleagues in 1989, showing that the capsules were completely harmless to patients.

The microcapsule’s individual islets are isolated by a protective shield, and designed to prevent the islet from immune attack, removing the need for immunosuppression. Dr. Calafiore has also successfully transplanted micro-encapsulated pig islets into patients with Type 1 Diabetes (T1D). This procedure overcomes another major obstacle of human islet transplantation: the scarcity of human donors.

Encapsulated neonatal pig Sertoli cell grafts have been proven to reverse hyperglycemia. The technology has gained preclinical proof of principle by reversing diabetes in NOD mice, the only existing animal model of human T1D (see article in JEM 2009 Oct 26; Therapy of experimental T1D by isolated Sertoli cell, Xenografts alone).

The company has recently demonstrated similar success, as a further preclinical proof of principle, in large animals, including transplantation of spontaneous diabetic monkeys (trial on-going). Our ultra- purified encapsulation has been approved for human use, and micro-encapsulated human islets have been successfully transplanted in a human trial as well (Diabetes Care, 2011).

The company is presently engaged in an ongoing Human Pilot Study Encapsulated Human Pancreatic Islet Transplantation in Patients Affected By Type1 Diabetes Mellitus.