GINER LIFE SCIENCES, INC. — Department of Health and Human Services SBIR Phase II: NIDDK

Description

PROJECT SUMMARY Pressure Management Technologies for Oxygenation of Implanted Insulin Secreting Cells The overall goal of the SBIR project is to develop an advancedminiaturized implantable electrochemical oxygen generator that supplies oxygen at well regulated dose and concentration to cells within an immunoisolation deviceso as to ensure their viability and function at high density and minimize overall implant sizeThe proposed Phase II program addresses several key areas of emphasis in this NIDDK special RFAThe core innovation is a patent pendingself regulating electrochemical gas generatorSREGGwhich intrinsically manages the pressure of oxygen generatedthis allows for careful control over oxygen dosedevice simplicity and dependabilityThe SREGG will be the definitive oxygen generation module of the Giner bioartificial pancreas with implanted oxygen supplyBAPIOSsystemThe fully implantable BAPIOSsystem includes the SREGGcell capsule filled with glucose regulating cells and power control electronicssystem recharging is via wireless transcutaneous energy transfer in the eveningsThe BAPIOSsystem development is taking place under separate Giner and NIDDKRDKfundingOxygenation of implanted cells is critical to maintaining viability and function at high cellular densitiesminimizing overall implant sizeThe first proposed application of the Giner BAPIOSsystem is a human pancreatic islet implant for treatment of typediabetesT Dwith future application to typediabetesThe SREGG is also a platform technology that may be combined with various cell implant devices and therapeutic cell types for additional cell therapiesThe BAPIOSsystem includes a cell implant capsule with clinical testing and proven safety recordsand will be fully implanted subcutaneously without infection prone percutaneous tubes leadsThis approach is superior to allogenic pancreas or intraportal islet transplantation because it will involve simple surgery and avoids the cost and health hazards of long term systemic immunosuppressionGiner s ultimate solution will leverage the most recent progress in stem cell derived cell sourcingobviating the need to procure allogeneic islets by donation and isolationThe BAPIOStreatment will eliminate accumulated strain of standard insulin drug therapyi eglycosylation of proteins and risk of sequelae due to frequent high blood sugarby imparting natural glucose controland the absence of worn pumpsfrequent blood testing and injections promises renewed freedom and active lifestyles for T D sufferersIn the Phase I projectsignificant progress was achieved in selection of materials and optimization of the SREGG cell design and constructionExcellent pressure regulationcell efficiency and long term performance were demonstrated in bench testing of several SREGG cell prototypesDevelopment of a novelcomplementary current control chipset was also undertakenand this circuitry showed high efficiencyreliability and amenability to substantial future miniaturization for implant applicationsA detailed SREGG design was generated to transition the cell beyond feasibility toward implant testing in Phase IIThe Phase II effort will further develop the SREGG cell for integration and implantationdesign and fabricate electronic controls and pressure monitoring devices in support of preclinical testsand demonstrate pressure control using the SREGG cell and associated bioartificial pancreas components in a small animal modelwith the goal of achievingdays of glucose control in a diabetic rat modelGiner will subcontract with a medical device manufacturer to specifyderisk and fabricate advanced preclinical systems under ISOdesign controlGiner will additionally assemble a collaborative team to support and conduct animal studiesdevelop protocols for preclinical clinical implementationand perform in vivo and post explant evaluations of the implanted devicesThe program will also contribute to the body of scientific work toward the understanding of the metabolic and insulin secretion behavior of high purity human islets under the conditions of macroencapsulation PROJECT NARRATIVE The goal of the Phase II program is to optimize and integrate a novelimplantable electrochemical oxygen generator which has passive pressure and generation rate limiting capabilityand thereby achieves fine control over oxygen dose while decreasing size and complexity of the implanted deviceThe oxygen produced will be a critical enabler of compact cell therapy implantsThe priority application for this transformative platform technology is a pancreatic islet implant with the potential to cure diabetesThe biocompatibility and performance of the generatoras well as the efficacy of a combination of the implanted generator and encapsulated pancreatic isletswill be evaluated in small animal models