Magnetic Flow Sorter for Pancreatic Islet Isolation

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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.