UMIP-87 – Co-Transplantation of Encapsulated Cell Types within Scaffolds for Cellular Therapies for Combined Intra and Peri-Capsule biologic Effect

Problem: Intrahepatic islet transplantation has been the gold standard for clinical islet transplantation trials aimed at treating patients with type 1 diabetes (T1D), or with surgically induced diabetes (pancreatectomy). FDA Phase 3 trials have been recently and successfully completed and islet transplantation is already approved in other countries including Canada Europe and Australia. However, the requirement for systemic immunosuppression of the recipients severely limits the applicability of this therapeutic strategy to the most severe cases of T1D, such as those with recurrent severe hypoglycemic events. Even if clinical outcomes continue to improve with the majority of islet transplants still functioning ove 7 year post-transplant, long-term graft dysfunction has been observed in several recipients of intrahepatic islet allografts, often requiring reintroduction of exogenous insulin. The development of extra-hepatic sites for islet transplantation has been a major focus of international research efforts, not only to overcome some of the limitations of intrahepatic islet transplantation, but most importantly to develop strategies for immunoprotection of the transplanted insulin producing cells without the requirement for recipient chronic immunosuppression. The University of Miami’s Diabetes Research Institute (DRI) has recently reported, in the New England Journal of Medicine, the first case of successful islet transplantation and over one year insulin independence tissue engineering an intra-abdominal mini endocrine pancreas using a resorbable biologic scaffold. Technology: Researchers at DRI have developed novel methods for producing a Biologic Active Scaffold (BAS) and a technique for cell and tissue transplantation including encapsulating islet cells in semipermeable ultra-thin shield coating technology and co-transplantation of “helper” cells and or their exosome/microvescicles to provide local immune protection and immunomodulation for tolerance induction without the use of chronic systemic immunosuppression. Peter Gutenberg 305-243-4604

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