An intravascular Bioartificial Pancreas (iBAP)

Project Summary 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 device 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) that 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 immunoprotection. The ultimate objective of this Phase IIB SBIR project is to create a clinical-scale iBAP and complete all pre-clinical testing in order to file for an IND for a future FIH clinical study.