A high oxygen capacity cell scaffold for the intravascular bioartifical pancreas (iBAP)

PROJECT SUMMARY TypeDiabetesT Daffects nearlymillion people in the United States overmillion people globallyA subset of patients have unstable T D because they possess poor glycemic control and severe hypoglycemia unawarenessWhile whole organ pancreas and islet transplantation can cure unstable T Dthese treatments are limited by immunosuppression therapy and scarcity of donor tissueIn contrastencapsulating islets within an immunoprotecting membrane is a promising approach to eliminate the need for immunosuppressionbut previous attempts suffered from low mass transfer rates of oxygenglucoseand insulin in diffusion based devicesIn order to solve the limitations of diffusionprevious groups tested intravascular convection based devices and showed some promisebut they provided insufficient ultrafiltration rates to provide sufficient islet oxygenation and glucose insulin kineticsIn contrastSilicon Kidney is commercializing the silicon nanopore membraneSNMwhich produces high levels of ultrafiltrateandgtx polymer membranes used in previous ultrafiltrate based BAP devicesat physiologic blood pressuresproviding exceptional convective mass transfer enabling a functional BAPTo further enhance islet oxygenationperfluorocarbonswhich are high oxygen capacity materialscan be incorporated into the islet cell scaffold to mimic the oxygen storage and release properties of hemoglobin by allowing oxygen to be stored during the islet s low oxygen consumption statefasting stateand released during the islet s high oxygen consumption statepost mealIn this Phase I SBIR projectwe will combine the SNM enabled convection and a perfluorocarbon based cell scaffold to demonstrate unprecedented islet oxygenation and functionwhile allowing a reduction in overall device size Project Narrative TypeDiabetesT Daffects approximatelymillion Americans and incurs a substantial cost to the US health care systemOur multidisciplinary team at Silicon Kidney LLC and the University of CaliforniaSan Francisco is developing a new intravascular bioartificial pancreasiBAPthat will improve T D outcomesincrease patient quality of lifeand significantly reduce the cost of T D on the health care system