A novel intravascular bioartificial pancreas device shows safety and islet functionality over thirty days in non-diabetic swine.

Abstract

In this study using a discordant, xenogeneic, transplant model we demonstrate functionality and safety of the first stent-based bioartificial pancreas 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 polytetrafluorethylene (PTFE) that forms channels to hold islets embedded in hydrogel. We completed a one-month study in the non-diabetic swine model (N=3) to test the safety of the device and to assess islet functionality after device retrieval. The luminal diameter of the devices from three 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 eBAP 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 groundwork for future work assessing in-vivo function of the device in diabetic swine.