Magnetic Flow Sorter for Pancreatic Islet Isolation

描述(申请人提供)：Techshot，Inc.已经成功地完成了SBIR第一阶段和第二阶段的研究，证明了通过使用专为此目的设计的四极磁分离器(“Quadrasep”)流动分选，可以将磁性标记的朗格汉斯猪胰岛从受污染的外分泌组织中分离出来。磁选分离的胰岛在形态和生理上优于目前使用的离心法分离的胰岛。一个第二阶段的竞争性更新项目被提出，在该项目中，Techshot将与亚利桑那大学、路易斯维尔大学、IKOTECH LLC和Vitacyte LLC的科学家合作，为监管部门批准和商业化准备这项技术。提出了一个商业计划，其中的目标市场最初是人类同种异体胰岛移植，这是一种临床批准和证明的程序。随后，随着这些市场的成熟和磁流分离的增加，同种和异种移植有望接踵而至。目的：Techshot建议进行翻译性研究，向FDA提交一份设备主文件(DMF)，支持使用Quadrasep作为制造工具，改进人胰岛的分离，用于治疗性移植，预防胰腺切除患者的糖尿病。描述：项目计划包括：(1)改进现有成功的四极分选机技术，以满足包括cGMP制造在内的必要的商业和监管标准；(2)通过一系列人胰岛纯化来证明该技术，并与使用广泛接受的胰岛评估标准的当前方法进行直接比较；以及(3)通过向美国食品和药物管理局申请设备主文件来批准该技术。预计该项目的成果将包括开发一种仪器和消耗品套件，以提高需求日益增加的胰岛移植的质量。这些结果反过来又代表着最终治愈1型糖尿病的机会增加了，而1型糖尿病目前只得到控制。

DESCRIPTION (provided by applicant): Techshot, Inc. has successfully completed SBIR Phase I and Phase II research demonstrating that magnetically labeled porcine islets of Langerhans can be isolated from contaminating exocrine tissue by flow sorting using a quadrupole magnetic separator ("Quadrasep") designed for that purpose. Magnetically sorted islets are superior in morphology and physiology to those isolated by the presently used centrifugation method. A Phase IIB Competing Renewal project is proposed in which Techshot will collaborate with scientists at the University of Arizona, University of Louisville, IKOTECH LLC and Vitacyte LLC to prepare this technology for regulatory approval and commercialization. A business plan is presented in which the target market is initially human isologous islet transplantation, a clinically approved and proven procedure. Subsequently allogeneic and xenogeneic transplantation are expected to follow as these markets mature along with increased use of magnetic flow separation. Objective: Techshot proposes translational research leading to the submission of a Device Master File (DMF) to the FDA supporting use of Quadrasep as a manufacturing tool for effecting the improved isolation of human pancreatic islets of Langerhans for therapeutic transplantation for the prevention of diabetes in pancreatectomy patients. Description: The project plan includes (1) Improving the existing successful quadrupole sorter technology to meet required commercial and regulatory standards including cGMP fabrication, (2) Proving the technology through a series of human islet purifications in direct comparison with current methods using widely accepted criteria for islet evaluation, and (3) Approving the technology through application for a Device Master File with the U. S. Food and Drug Administration. The outcome of the project is expected to include the development of an instrument and consumables kit that improves the quality of islet transplants for which there is increasing demand. These outcomes, in turn, represent improved opportunities to eventually cure type-1 diabetes, which is currently only managed.