Techshot, Inc. has successfully completed SBIR Phase I and Phase II research demonstrating that magnetically labeled porcine islets of Langerhans can be isolated from contaminating exocrine tissue by flow sorting using a quadrupole magnetic separator (""""""""Quadrasep"""""""") designed for that purpose. Magnetically sorted islets are superior in morphology and physiology to those isolated by the presently used centrifugation method. A Phase IIB Competing Renewal project is proposed in which Techshot will collaborate with scientists at the University of Arizona, University of Louisville, IKOTECH LLC and Vitacyte LLC to prepare this technology for regulatory approval and commercialization. A business plan is presented in which the target market is initially human isologous islet transplantation, a clinically approved and proven procedure. Subsequently allogeneic and xenogeneic transplantation are expected to follow as these markets mature along with increased use of magnetic flow separation. Objective: Techshot proposes translational research leading to the submission of a Device Master File (DMF) to the FDA supporting use of Quadrasep as a manufacturing tool for effecting the improved isolation of human pancreatic islets of Langerhans for therapeutic transplantation for the prevention of diabetes in pancreatectomy patients. Description: The project plan includes (1) Improving the existing successful quadrupole sorter technology to meet required commercial and regulatory standards including cGMP fabrication, (2) Proving the technology through a series of human islet purifications in direct comparison with current methods using widely accepted criteria for islet evaluation, and (3) Approving the technology through application for a Device Master File with the U. S. Food and Drug Administration. The outcome of the project is expected to include the development of an instrument and consumables kit that improves the quality of islet transplants for which there is increasing demand. These outcomes, in turn, represent improved opportunities to eventually cure type-1 diabetes, which is currently only managed.
There are more than 3 million Type 1 diabetes patients in the United States and an additional 30,000 new patients per year. A permanent cure (insulin independence) for Type 1 diabetes has been tested on a few hundred patients in Phase 3 clinical trials. It consists of producing healthy islets of Langerhans, small bits of tissue in the pancreas that produce insulin in response to high blood sugar, from organ-donor pancreases. These islets are transplanted to the liver of the patient, who sometimes returns to normal blood sugar levels. Due to islet loss and damage during the isolation process only 26% of the transplant recipients received enough islets from one organ, and 74% of the recipients required islets from two to four donors. Separating islets by a new method, magnetic flow sorting has been shown to produce superior samples of islets. The proposed project will further demonstrate this fact and prepare the method of magnetic flow sorting for the improved manufacture of purified islets for use in cell therapies.
