Automated System for High Yield Pancreatic Islet Isolation

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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.