An intravascular bioartificial pancreas (IBAP) - approximately 3 million americans and around 24 million people worldwide are affected by type 1 diabetes (T1D)

Exogenous insulin injection, allogeneic whole organ pancreas transplantation, and allogeneic islet transplantation are the most common treatments for T1D. These treatments can achieve glycemic control for many patients but result in serious complications. A bioartificial pancreas is a promising treatment for T1D because IT contains functional islets. However, previous attempts to develop a bioartificial pancreas have been severely limited by insufficient mass transfer within the islet chamber. Silicon kidney LLC has developed and is commercializing the silicon nanopore membranes (SNM), which achieves high-efficiency blood ultrafiltration while selectively retaining specific solutes. The ultra-high hydraulic permeability characteristic of the SNM will enable appropriate mass transport (especially oxygen, glucose, and insulin) within the islet chamber to achieve optimal islet performance, while the ultra-selective pore characteristic of the SNM enable unprecedented immunoisolation. The ultimate objective of this phase II sbir project is to create a full-scale IBAP containing a clinically relevant islet dose and perform pre-clinical hemocompatibility and functionality testing in a large scale animal model.