Islet cell transplantation is an alternative therapy for the treatment of diabetes but requires the administration of immunosuppressive drugs to avoid host rejection. Immunoisolation devices such as TheraCyte device protect islet cells from the host response and thus eliminate the need for immunosuppressive drugs. However, once implanted, hypoxic conditions around and within the device result in loss of islet cell function and viability. To alleviate these conditions, the Papas lab in collaboration with TheraCyte and other industry partners developed devices that enable supplemental oxygen delivery to encapsulated cells. Monitoring oxygen supply within implanted devices is now recognized as critical, but it is limited by currently available instrumentation that is bulky, invasive, or have slow measurement times. The Lumee O2 sensor by Profusa is a flexible, wireless, injectable fluorescent sensor that provides continuous and non-invasive measurements of oxygen. The Lumee O2 sensor has been tested extensively in small and large pre-clinical models as well as in humans for up to 1 year. We propose the integration of Profusa Lumee O2 sensors into oxygen enabled TheraCyte immunoisolation devices for the non-invasive monitoring of oxygen concentrations within these devices.
Specific aims for Phase I will focus on in vitro validation of oxygen measurements from Lumee O2 sensors within oxygen enabled TheraCyte devices and assess different oxygen supplementation approaches as measured by Lumee O2 sensors on device vascularization in vivo. Main outcomes of this collaborative effort will be monitoring oxygen delivery to devices to improve islet cellular function and the demonstration of Lumee O2 sensors as a new tool for oxygen monitoring within implantable cellular-based devices.

Public Health Relevance

Immunoisolation devices for islet cell transplantation require oxygen supplementation to maintain cell function and viability in the hypoxic tissue environment post-implantation. We propose to integrate Profusa?s Lumee O2 sensors into oxygen enabled TheraCyte immunisolation devices as a method for non-invasively monitoring oxygen delivery and concentration within these devices. Successful integration of these devices will allow for better monitoring of oxygen levels and supplementation and understanding the effect of oxygen concentration on device function.

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 I (R43)
Project #
1R43DK113519-01
Application #
9306721
Study Section
Special Emphasis Panel (ZDK1)
Program Officer
Arreaza-Rubin, Guillermo
Project Start
2017-04-01
Project End
2018-09-30
Budget Start
2017-04-01
Budget End
2018-09-30
Support Year
1
Fiscal Year
2017
Total Cost
Indirect Cost
Name
Profusa, Inc.
Department
Type
DUNS #
830219338
City
South San Francisco
State
CA
Country
United States
Zip Code
94080