A novel intravascular bioartificial pancreas device shows safety and islet functionality over 30 days in nondiabetic swine

Abstract

In this study using a discordant, xenogeneic, transplant model we demonstrate the functionality and safety of the first stent-based bioartificial pancreas (BAP) device implanted endovascularly into an artery, harnessing the high oxygen content in blood to support islet viability. The device is a self-expanding nitinol stent that is coated with a bilayer of polytetrafluoroethylene that forms channels to hold islets embedded in a hydrogel. We completed a 1-month study in the nondiabetic swine model (N = 3) to test the safety of the device and to assess islet functionality after device recovery. The luminal diameter of the devices from 3 animals on day 0 and day 30 was 10.01 ± 0.408 mm and 10.05 ± 0.25 mm, respectively. The stimulation index of the control and endovascular BAP devices explanted at day 30 were 3.35 ± 0.97 and 4.83 ±1.20, respectively, and the islets stained positively for insulin and glucagon after 30 days in vivo. This pilot study shows that BAP implantation into a peripheral artery is safe and supports islet functionality over 30 days, providing the groundwork for future work assessing the in vivo function of the device in diabetic swine.