Islet culture, shipping, and infusion device

描述（申请人提供）：胰岛的培养和运输是胰岛移植研究的一个组成部分。烧瓶、培养皿和袋子是用来执行这个角色的设备。然而，这些设备具有固有的设计特征，使它们不适合岛屿文化和岛屿航运的独特需求。这导致使用太多的设备来维持胰岛制备，污染的可能性很高，过程控制严重受限，并且在运输过程中造成胰岛损坏。不幸的是，几乎没有采取措施来解决现有设备固有的问题。我们建议创造一种优越的设备，它非常适合给胰岛充氧，并根据胰岛社区的需求量身定制。这将是唯一能够培养，运输和注入整个胰岛分离的设备。这种装置被称为单层透气性装置（SLD）。我们的调查预计将达到五个具体目标。目标1将定义一种高密度SLD胰岛培养方案，当整个胰岛制剂在单个设备中培养至少7天而不喂养时，该方案提供的胰岛质量优于现有设备，但免疫原性可能低于现有设备。结果将由各种技术决定，包括氧气消耗率（OCR）， OCR/DNA和分子谱。目标2将使SLD从一种文化适应到一种运输设备。目标3将创造一种新型的陀螺仪集装箱（GSC），无需电子控制即可作为孵化器，并在运输过程中保持SLD独立于其外部集装箱的定位。这基本上允许在运输过程中培养胰岛。Aim 4将验证Aim 2的SLD和Aim 3的GSC提供的胰岛组织与现有方法相比具有更高的活胰岛产量、质量和降低的免疫原性。目的5将改进用于胰岛输注的SLD，并验证用于胰岛培养、运输和输注的SLD相对于现有方法的优越性。

DESCRIPTION (provided by applicant): The culture and shipment of islets are an integral part of islet transplant research. Flasks, petri dishes, and bags are the devices used to perform that role. However, these devices have inherent design characteristics that make them poorly suited to the unique needs of islet culture and islet shipping. This results in the use of far too many devices to maintain an islet preparation, a high potential for contamination, severely limited process control, and islet damage during shipping. Unfortunately, little effort has been undertaken to address the problems inherent to existing devices. We propose the creation of a superior device that is ideally suited to oxygenate islets and is tailored to the needs of the islet community. It will be the only device capable of culturing, shipping, and infusing an entire pancreatic islet isolation. This device is referred to as the single layer gas permeable device (SLD). Our investigation is expected to achieve five specific aims. Aim 1 will define a high-density SLD islet culture protocol that provides islets of superior quality and less immunogenicity than possible with existing devices when an entire islet preparation is cultured in a single device for at least seven-days without feeding. Outcomes will be determined by a variety of techniques including oxygen consumption rate (OCR), OCR/DNA, and molecular profiling. Aim 2 will adapt the SLD from a culture to a shipping device. Aim 3 will create a novel gyroscopic shipping container (GSC) that functions as an incubator without need of electronic controls and maintains the SLD in a standing position independent of how its outer container is oriented during shipping. This essentially allows islets to be cultured during shipping. Aim 4 will verify that the SLD of Aim 2 and the GSC of Aim 3 deliver islet tissue with superior viable islet yield, quality, and reduced immunogenicity relative to existing methods. Aim 5 will modify the SLD for islet transfusion and verify the superiority of the SLD for islet culture, shipping, and infusion relative to existing methods. Project Narrative: Islet transplants hold promise to provide a better quality of life for those afflicted with diabetes and reduce health care cost to society. There are no cell culture devices on the market that are designed with the attributes needed to efficiently oxygenate islets during culture and shipping. This grant is intended to create a gas permeable device (SLD) that can culture, ship, and infuse islets with maximum efficiency.