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.

Public Health Relevance

Type 1 Diabetes (T1D) affects approximately 3 million Americans and incurs a substantial cost to the US health care system. Our multidisciplinary team at Silicon Kidney LLC and the University of California, San Francisco is developing a new intravascular bioartificial pancreas (iBAP) that will improve T1D outcomes, increase patient quality of life, and significantly reduce the cost of T1D on the health care system.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44DK104299-03
Application #
9743166
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Arreaza-Rubin, Guillermo
Project Start
2014-09-23
Project End
2020-07-31
Budget Start
2019-08-01
Budget End
2020-07-31
Support Year
3
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Silicon Kidney, LLC
Department
Type
DUNS #
966332822
City
San Ramon
State
CA
Country
United States
Zip Code
94583