Automated System for High Yield Pancreatic Islet Isolation

项目总结/摘要 该二期项目旨在开发一种用于高产量胰岛分离的自动化系统， 用于胰岛移植（1型糖尿病的新兴疗法）和糖尿病研究。的 胰岛移植的有效性主要依赖于移植胰岛的质量和数量， 其分离自死亡的人类捐赠胰腺。然而，目前用于胰岛的方法 隔离是高度依赖于用户的，提供了少量的胰岛，并且遭受接近50%的处理 失败率这些缺点使得需要频繁使用许多供体胰腺和多个移植物。 每个患者的移植，以实现良好的结果，使胰岛移植非常低效和成本- 禁止的。缺乏可靠和易于使用的胰岛分离工具也阻碍了许多研究人员 获取高质量的胰岛进行研究。为了克服这些局限性，CG Scientific 开发正在申请专利的“自动细胞分离平台”（ACIP）技术， 胰岛分离的自动化系统。该技术具有独特的配置，以（1）实现高效 酶消化，（2）以封闭系统形式自动化分离过程，以及（3）突破 这些限制阻止了当前方法实现高胰岛回收率和存活率。使用猪 作为第一阶段的模型系统，该公司已经证明了成功的胰岛分离， 与当前方法相比，胰岛回收率高约2.4倍， 指数.胰岛具有突出的形态和葡萄糖刺激的胰岛素分泌功能。 自动化系统将潜在地消除与用户相关的过程故障，并提供单供体胰岛。 移植非常有效-只使用一个供体胰腺和一个移植受体- 降低80%的成本。在第二阶段，研究者团队将（1）开发功能齐全的产品 原型，（2）优化用于人和猪胰岛的自动原型的性能， (3)与当前方法相比，基准上级胰岛分离能力，以及（4）证明 使用小鼠模型观察所得胰岛用于糖尿病逆转的临床前功效。这项II期 项目将产生重要的数据和专有技术，用于（1）过渡到制造，（2）获得 监管批准，以及（3）产品商业化。研究者团队包括医疗器械 专家、胰岛生物学家、工程师和专门从事临床胰岛制造的医生， 移植该项目的成功将导致一种重要工具的商业化， 不仅使单供体胰岛移植非常有效，负担得起，而且 加速广泛的糖尿病研究-从而使世界各地的许多患者受益 患有糖尿病的人

Project Summary/Abstract This Phase II project aims to develop an automated system for high-yield pancreatic islet isolation for use in islet transplantation (an emerging therapy for type 1 diabetes) and diabetes research. The effectiveness of islet transplantation relies critically on the quality and quantity of the transplanted islets, which are isolated from deceased human donor pancreata. However, the current method for islet isolation is highly user-dependent, provides low numbers of islets, and suffers close to 50% process failure rates. These drawbacks necessitate the frequent use of many donor pancreata and multiple transplants per patient to achieve good outcomes, making islet transplantation highly inefficient and cost- prohibitive. The lack of a reliable and easy-to-use tool for islet isolation also precludes many researchers from obtaining high-quality islets for their research. To overcome these limitations, CG Scientific is developing a patent-pending “automated cell isolation platform” (ACIP) technology to create an automated system for islet isolation. The technology has a unique configuration to (1) enable efficient enzyme digestion, (2) automate the isolation process in a closed-system format, and (3) break through limitations that prevent current methods from achieving high islet recovery and viability. Using porcine pancreata as a model system in Phase I, the company has demonstrated successful islet isolation, with ~2.4x higher islet recovery compared to the current method and an unmatched islet viability of ~95% on average. The islets exhibit outstanding morphology and glucose-stimulated insulin secretion function. The automated system will potentially eliminate user-related process failure and render single-donor islet transplantation highly efficacious―using only one donor pancreas and one transplant per recipient―with up to 80% cost reduction. In Phase II, the investigator team will (1) develop a fully functional product prototype, (2) optimize the performance of the automated prototype for both human and porcine islets, (3) benchmark superior islet isolation capabilities compared to the current method, and (4) demonstrate the pre-clinical efficacy of the resulting islets for diabetes reversal using a mouse model. This Phase II project will generate significant data and know-how for (1) transitioning to manufacturing, (2) obtaining regulatory approval, and (3) product commercialization. The investigator team includes medical device experts, islet biologists, engineers, and medical doctors who specialize in clinical islet manufacturing and transplantation. The success of this project will result in the commercialization of an essential tool that will not only make single-donor islet transplantation highly effective, affordable, and available, but also accelerate a wide range of diabetes research―thereby benefiting the many patients around the world who suffer from diabetes.