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.

中文翻译：

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一种新型血管内生物人工胰腺装置在非糖尿病猪中显示出超过 30 天的安全性和胰岛功能。


在这项研究中使用不一致的异种移植模型，我们展示了第一个基于支架的生物人工胰腺装置的功能和安全性，该装置通过血管内植入动脉，利用血液中的高氧含量来支持胰岛活力。该装置是一种自膨胀镍钛合金支架，涂有双层聚四氟乙烯 （PTFE），可形成通道以固定嵌入水凝胶中的胰岛。我们在非糖尿病猪模型 （N=3） 中完成了一项为期一个月的研究，以测试设备的安全性并评估设备取回后胰岛的功能。第 0 天和第 30 天，来自三只动物的装置的管腔直径分别为 10.01 ± 0.408 毫米和 10.05 ± 0.25 毫米。第 30 天外植的对照和 eBAP 装置的刺激指数分别为 3.35 ± 0.97 和 4.83 ±1.20，体内 30 d 后胰岛胰岛素和胰高血糖素染色阳性。这项初步研究表明，BAP 植入外周动脉是安全的，并且在 30 天内支持胰岛功能，为未来评估该装置在糖尿病猪体内功能的工作提供了基础。