GINER INC — Department of Health and Human Services SBIR Phase II: 200

Description

DESCRIPTION provided by applicant High Cell Density Bioartificial Pancreas Enabled by Implantable Oxygen Generator The overall goal of the SBIR project is to develop and test a human scale BioArtificial Pancreas with Implantable Oxygen Supply BAPIOS tm This consists of a miniaturized implantable electrochemical oxygen generator EOG that will continuously supply oxygen to islets or cells within an immunoisolation cell implant device Oxygenation maintains cell viability and function at high cellular densities minimizing overall implant size The first proposed application of this platform technology is a human pancreatic islet implant for the treatment of Type diabetes T D The implantable EOG is also a platform technology that may be combined with various cell implant devices and therapeutic cell types for additional cell therapies for indications such as liver failure Parkinsonandapos s disease para thyroid disease and pancreatectomy The Giner BAPIOS tm system includes a cell implant capsule with clinical testing and proven safety records The BAPIOS tm system will be fully implanted subcutaneously without infection prone percutaneous tubes leads Intraportal Pancreatic Islet Allogeneic Transplantation IPIATx liver is emerging as a promising treatment for select T D patients Results from leading centers demonstrate insulin independence for more than years for of the recipients this approaches the success rate of a complex whole pancreas transplant but IPIATx currently requires islets from donors Widespread clinical application of islet transplantation for T D is hindered by critical barriers including the need for systemic immunosuppression for the current transplant site and the limited supply of human islet tissue andlt U S pancreas donors per year The use of biocompatible retrievable cell isolating devices addresses these critical barriers by enabling the more effective and efficient use of allogeneic islets without immunosuppression and the eventual use of alternative sources of glucose responsive insulin secreting cells In the PhI project it was definitively demonstrate in a rat model that oxygen is necessary to allow the viability and function of a high density implant human islet equivalents IE per cm The results also showed that subcutaneous encapsulated oxygenated implants reversed diabetes with fewer islets lower marginal mass than literature results for the liver or kidney capsule sites in this animal model miniature EOG was designed and fabricated testing demonstrated more than sufficient oxygen for supporting the islet dose anticipated for human implant The outcome of the PhII project will be the first bioartificial pancreas with implantable oxygen supply The Ph II Giner BAPIOS tm system will have a modular design including a an implantable human scale EOG with novel provisions for biocompatibility and access to body water b a power system utilizing transcutaneous energy transfer and c an established cell capsule TheraCyte tm tailored for oxygen delivery The program concludes with preclinical trial testing the fully implantable PhI system and complete design for the human clinical model of the Giner BAPIOS tm system for future implementation and clinical testing PUBLIC HEALTH RELEVANCE The goal of this project is to develop a bioartificial pancreas that includes a remotely powered miniature oxygen generator that can be implanted in the body The oxygen produced will be a critical enabler of compact cell therapy implants The priority application for this transformative platform technology is a pancreatic islet implant with the potential to cure diabetes