GINER INC — Department of Health and Human Services SBIR Phase I: NIDDK

Description

PROJECT SUMMARY This Phase I program is aimed at achieving high viability and function of insulin secreting cells through sustained O delivery to implanted tissues Giner has successfully demonstrated the benefits of supplemental O in the survival and function of pancreatic islets in a densely packed immunoisolation device The first proposed application of this platform technology is pancreatic islet implant for the treatment of Type diabetes T D The specific goal is to design and demonstrate an electrochemical O generator with passive pressure limiting capability implemented as a pressure differential sensitive cell construction which limits cell current and gas generation and achieves fine control over O dose while decreasing size and complexity of the implanted device The combination of O generation with a well characterized immunoisolation device is termed a bioartificial pancreas with implantable oxygen supply BAPIOS The implantable O generator is a platform technology that is amenable to oxygenation of other cellular therapies for conditions such as liver failure Parkinson s disease para thyroid disease and hemophilia Pancreatic islet allotransplantation is in U S clinical trials There are also results from leading centers demonstrating insulin independence for more than years for of the recipients However widespread clinical application of for T D is hindered by two critical barriers the need for systemic immunosuppression for the current intraportal liver transplant site and by the finite and low supply of human islet tissue a few thousand suitable donors per year The use of biocompatible retrievable cell isolating devices may address these critical barriers by enabling the more effective and efficient use of allogeneic islets without immunosuppression and the eventual use of stem cell derived or xenogeneic islets with minimum or no immunosuppression Autotransplantation for pancreatitis patients and pre cancer diagnosis could also benefit from a simple implant procedure with retrievability and cellular immunoisolation Current cell implant devices have insufficient oxygen even with prevascularization of the device to provide the high cellular densities required for practically sized clinical implants The proposed innovation is a critical advance for Giner s oxygen generation technology and will enable improved reliability and density of the BAPIOS implantable cell therapy capsule with continuous oxygen supply The Specific Aims are Aim Advance the SREGG from the initial prototype phase to an application specific device for integration with oxygenated cell capsule and in vitro tests Aim Fabrication and evaluation of prototype SREGG cells for bioartificial pancreas oxygenation and Aim Preliminary component and packaging design of clinical SREGG for T D therapy device This project will provide the groundwork for final design and fabrication of BAPIOS integrated units in Phase II and validation in animal studies ultimately leading to treatment of T D in humans PROJECT NARRATIVE The goal of the Phase I program is to design and demonstrate a novel implantable electrochemical oxygen generator which has passive pressure and generation rate limiting capability and thereby achieves fine control over oxygen dose while decreasing size and complexity of the implanted device 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