Magnetic Flow Sorter for Pancreatic Islet Isolation

用于胰岛分离的磁流分选机

• 批准号: 6990623
• 负责人: PAUL W TODD
• 金额: $ 10万
• 依托单位: TECHSHOT, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2006-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6990623
• 关键词: biomedical equipment development; clinical biomedical equipment; diabetes mellitus therapy; immunomagnetic separation; insulin dependent diabetes mellitus; pancreatic islet transplantation; pancreatic islets

DESCRIPTION (provided by applicant): SHOT proposes research leading to a magnetic separation technology that will provide an increase in efficiency and yield of pancreatic islets of Langherhans isolated from donor pancreatic tissue. Pancreatic islet transplantation is a rapidly developing method of treatment and has been successfully enabling clinical trial recipients to lead an insulin injection-independent lifestyle for three or more years. One of the most significant issues with bringing pancreatic islet transplantation to the greater public is the difficulty of recovering viable islets from the human donor pancreas. Current isolation and purification techniques result in the loss of 30-50% of the original islets. This loss of viable islets almost always results in the need to utilize two pancreases for a single transplant (the "Edmonton Protocol"). The proposed innovation is a revolutionary new device that is capable of magnetically isolating large clusters of cells, in particular, pancreatic islets, towards the end goal of successful single organ islet transplantations. The ultimate technical goal of this research is to increase the resulting percentage of viable, isolated, and purified islets recovered during the isolation process to >80% of the original islet population. The resulting purified islets will be ideally suited for transplantation into Type I diabetic patients. This new system will be based on the Quadrupole Magnetic flow Sorter (QMS) technology, which SHOT is developing in conjunction with the original inventors at The Ohio State University and Cleveland Clinic Foundation. The present QMS technology is capable of handling cellular (6-40 mu/m diameter) particles, whereas processing the larger isletsized (150-350 urn) particles will require significant modifications and redesign. The new QMS device will produce pure samples of pancreatic islets for transplants by solving some of the well-known problems associated with human and xenogeneic islet preparations. SHOT will (1) design a precision flow channel to accommodate magnetized islet separation, (2) design a quadrupole magnet assembly with a suitable size and field strength for the flow channel and islet isolation process, and (3) reconfigure a cell separation QMS system to accommodate the sample size and throughput speed required for isolating pancreatic islets. The Phase I effort is designed to prove the feasibility of using the QMS technology for isolating pancreatic islets and will result in a completed design of an instrument that is ready for fabrication and testing in Phase II.

描述（由申请人提供）：SHOT提出了一项磁分离技术研究，该技术将提高从供体胰腺组织中分离的Langherhans胰岛的效率和产量。胰岛移植是一种快速发展的治疗方法，并且已经成功地使临床试验接受者能够过三年或更长时间的胰岛素注射独立生活方式。将胰岛移植带给更多公众的最重要问题之一是难以从人类供体胰腺中回收有活力的胰岛。目前的分离和纯化技术导致30-50%的原始胰岛损失。这种存活胰岛的丧失几乎总是导致需要利用两个胰腺进行单次移植（“埃德蒙顿方案”）。拟议的创新是一种革命性的新设备，能够磁性隔离大细胞群，特别是胰岛，以实现成功的单器官胰岛移植的最终目标。本研究的最终技术目标是将分离过程中回收的活的、分离的和纯化的胰岛的百分比增加到原始胰岛群体的>80%。所得纯化的胰岛将理想地适合于移植到I型糖尿病患者中。这一新系统将基于四极磁流分选机（QMS）技术，SHOT正在与俄亥俄州州立大学和克利夫兰诊所基金会的原始发明者共同开发该技术。目前的QMS技术能够处理细胞（6-40 μ m/m直径）颗粒，而处理较大的胰岛大小（150-350 μ m）颗粒将需要显著的修改和重新设计。新的QMS设备将通过解决与人类和异种胰岛制备相关的一些众所周知的问题来生产用于移植的胰岛纯样品。SHOT将（1）设计一个精密的流动通道，以适应磁化胰岛分离，（2）设计一个四极磁铁组件，具有合适的尺寸和磁场强度，用于流动通道和胰岛分离过程，（3）重新配置细胞分离QMS系统，以适应分离胰岛所需的样本量和通量速度。第一阶段的工作旨在证明使用QMS技术分离胰岛的可行性，并将导致完成仪器的设计，准备在第二阶段进行制造和测试。