Automated System for High Yield Pancreatic Islet Isolation

项目摘要/摘要 该项目旨在开发一种用于可重复性高产量胰岛分离的自动化系统， 极大地改善胰岛移植，造福于I型糖尿病(T1D)患者。新的 系统将使用最先进的技术-CG Science正在申请专利的自动细胞分离 平台(ACIP)及其专有的“不让小岛掉队”(NILB)过程--以取代近30年来-- 并实现较高的胰岛回收率、存活率、功能和重复性。这个 自动化系统将实现标准化的胰岛隔离，并促进当地实验室的胰岛隔离 显著减少破坏性冷缺血时间，从而提供更多的胰岛和 质量。这些改进可能会使许多捐赠者的胰腺--否则将是 因质量不佳而被取消资格-用于胰岛移植，从而显著减少 胰岛移植的成本，并有可能使单一供体胰岛移植成为 标准疗法。与哈伦博士合作，哈伦博士曾是美国国立卫生研究院糖尿病分部的负责人 糖尿病、消化和肾脏疾病研究所(NIDDK)以及Greiner和Bortell博士， CG Science拥有黄金标准糖尿病NRG-Akita小鼠模型的原始开发者 证明其技术有可能将胰岛回收率提高约2.5倍。这个项目的第一阶段 该项目的具体目标是开发一种用于自动化胰岛隔离的放大原型设备，Benchmark 对照当前标准，展示其优越的性能，并验证体外和体内 以猪胰腺为模型系统，对分离的胰岛功能进行了研究。圆满完成 该项目的实施将导致标准化、自动化和高产小岛的商业化 隔离系统-第一个现代胰岛隔离系统-加速糖尿病研究和 使单一捐赠者胰岛移植标准化，从而使美国130万人受益 美国和世界各地遭受T1D折磨的4000多万人。

Project Summary/Abstract This project aims to develop an automated system for reproducible high-yield pancreatic islet isolation, to greatly improve islet transplantation and benefit patients who suffer type I diabetes (T1D). The new system will use state-of-the-art technologies — CG Scientific’s patent-pending automated cell isolation platform (ACIP) and its proprietary “no islet left behind” (NILB) process — to replace the nearly 30-year- old Ricordi apparatus and achieve high islet recovery, viability, function and reproducibility. The automated system will enable standardized islet isolation, and facilitate islet isolation at local laboratories to drastically reduce the damaging cold ischemic time, thereby providing islets of higher quantity and quality. These improvements will potentially allow many donor pancreata — which would otherwise be disqualified due to poor quality — to be used for islet transplantation, thereby significantly reducing the cost of islet transplantation and potentially enabling single-donor islet transplantation to become a standard therapy. In collaboration with Dr. Harlan, former Head of the Diabetes Branch at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and Drs. Greiner and Bortell, the original developers of the gold-standard diabetic NRG-Akita mouse model, CG Scientific has demonstrated that its technologies can potentially increase islet recovery by ~2.5x. Phase I of this project specifically aims to develop a scaled-up prototype device for automated islet isolation, benchmark against current standards, demonstrate its superior performance, and validate the ex vivo and in vivo functions of the isolated islets, using porcine pancreata as the model system. The successful completion of this project will result in the commercialization of a standardized, automated and high-yield islet isolation system — the first modern islet isolation system — that accelerates diabetes research and standardizes single-donor islet transplantation, thereby benefiting the 1.3 million people in the United States and the over 40 million people worldwide who suffer T1D.