R&D PARTNER

Research & Development Partner: University of Perugia, Italy

ALTuCELL is proud to partner with the University of Perugia in Italy, a globally recognized leader in cell encapsulation research. The partnership is anchored in the Laboratory of Endocrinology and Cell Transplantation, founded in 1987 by Professor Riccardo Calafiore within the Department of Internal Medicine, School of Medicine.

This pioneering laboratory has been at the forefront of developing microencapsulation technologies using natural biopolymers, particularly sodium alginate derived from marine brown seaweed. Over the past two decades, the team has developed proprietary methods to ultra-purify alginate, transforming it into a clinical-grade biomaterial suitable for human use, and refining microcapsule size, shape, and mechanical properties to meet therapeutic needs.

Professor Calafiore’s groundbreaking work has significantly advanced the field of cell-based therapy, particularly in the treatment of Type 1 Diabetes (T1D). In 1989, his team became the first to implant microencapsulated human islet cells into diabetic patients, demonstrating both safety and biocompatibility without the need for immunosuppression.

Key achievements from this collaboration include:

• Development of immune-isolating microcapsules that shield therapeutic cells from host immune responses, eliminating the need for systemic immunosuppressants
• Successful transplantation of encapsulated porcine islets into human T1D patients, addressing the challenge of limited human donor islets
• Reversal of hyperglycemia in animal models using encapsulated neonatal porcine Sertoli cell grafts
• Preclinical proof-of-concept established in NOD mice, the gold standard model for human T1D (JEM, Oct 2009)
• Ongoing large-animal studies, including spontaneous diabetic monkey models, with promising early results
• Clinical validation, including a 2011 human trial using ultra-purified, microencapsulated human islets (published in Diabetes Care)

Currently, ALTuCELL and the University of Perugia are engaged in an ongoing Human Pilot Study focused on encapsulated human pancreatic islet transplantation in patients with Type 1 Diabetes Mellitus. This work represents a critical step toward scalable, clinically viable cell-based therapies that can restore function without compromising immune safety.