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中不可或缺的一部分。烧瓶、培养皿和袋子都是用来扮演这一角色的设备。然而，这些设备具有固有的设计特点，使得它们不太适合胰岛培养和胰岛运输的独特需求。这导致使用太多的设备来维持胰岛制备、高污染可能性、严重限制了工艺控制，以及在运输过程中对胰岛的损害。不幸的是，几乎没有采取任何努力来解决现有设备固有的问题。我们建议创造一种优越的装置，它非常适合给胰岛充氧，并根据胰岛社区的需要量身定做。这将是唯一能够培养、运输和输注整个胰岛分离的设备。这种装置称为单层透气装置(SLD)。我们的调查预计将实现五个具体目标。目标1将定义一种高密度SLD胰岛培养方案，与现有设备相比，当整个胰岛制剂在单个设备中培养至少7天而不喂食时，该方案提供质量更高、免疫原性更低的胰岛。结果将由各种技术决定，包括耗氧率(OCR)、OCR/DNA和分子图谱。AIM 2将把SLD从培养物改造成运输设备。AIM 3将创造一种新型的陀螺仪运输容器(GSC)，它的功能是充当孵化器，不需要电子控制，并保持SLD处于站立位置，而与其外集装箱在运输过程中如何定位无关。这基本上允许在运输过程中培养胰岛。目的4将验证与现有方法相比，AIM 2的SLD和AIM 3的GSC以更高的存活胰岛产量、质量和降低的免疫原性提供胰岛组织。目的5将改进用于胰岛输注的SLD，并验证SLD在胰岛培养、运输和输注方面相对于现有方法的优越性。 项目简介：胰岛移植有望为糖尿病患者提供更好的生活质量，并降低社会的医疗成本。目前市场上还没有一种细胞培养设备，其设计具有在培养和运输过程中使胰岛有效充氧所需的属性。这笔赠款旨在创造一种气体渗透装置(SLD)，可以最大限度地培养、运输和注入胰岛。

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.