Improving Pancreas/Islets Preservation HTS/CryoStor

DESCRIPTION (provided by applicant): Cell Preservation Services Inc. (CPSI) plans to develop several new products for the improved hypothermic storage and cryopreservation of isolated human pancreatic islets to be used for treating Type 1 diabetes. CPSI and its manufacturing partner, BioLife Solutions Inc., have developed two, protein-free, preservation solution platforms now being used in FDA-approved cell therapy procedures. Applications range from cellular cardiomyoplasty to the preservation of primary human hepatocytes. The HypoThermosol (HTS) platform is designed for hypothermic storage (4?C); whereas the CryoStor series o is formulated for cryopreservation (-196(C). This Phase I project is devoted to developing a series of linked islets preservation products referred to as HTS-Islets, HTSRxCUE-Islets, CryoStor-Islets, and CPRxCUE-Islets designed for the optimal preservation and recovery/rescue of hypothermically stored and cryopreserved isolated human islets. Phase 2 studies will be dedicated to developing a similar set of linked hypothermic solutions, HTS-Pancreas and HTSRxCUE-Pancreas, formulated for the improved preservation of whole human pancreas. The overall intention and unique feature of this Phase 1/2 program is the development of six linked preservation solutions to be used in tandem which will result in improved human islets recovery, isolation and storage - a sequence process that has yet to be used for any cell therapy application. The specific aims are: (1) Identifying and modulating the stress pathways activated in human islets as a consequence of preservation; (2) Testing variants of the whole pancreas two layer method for islets preservation; and (3) Leveraging the literature on ischemia and reperfusion to develop recovery or rescue solutions for islets that are warmed to normothermic temperatures subsequent to hypothermic storage or cryopreservation. These new preservation solutions will help increase the availability of islets through improved whole pancreas preservation as well as improve the viability and function of isolated islets currently used in cell therapy applications to treat Type 1 diabetes. Several cell therapy and tissue engineering companies in the United States are now shipping their living products worldwide. Cell Preservation Services Inc. is a unique company that specializes in developing solutions for the purpose of maintaining these products in a "state of suspended animation" until such time that they arrive at their clinical and non-clinical destinations. This grant is designed to develop four linked preservation solutions that will improve the shipping and storage of isolated human islets and thus will facilitate the time management of human islets used for cell therapy to treat Type 1 diabetes.