Hypothermic and Cryopreservation of Human Blood Vessels

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DESCRIPTION (provided by applicant): BioLife Solutions Inc is a Biological Packaging company dedicated to developing improved solutions for hypothermic storage (4 to 8C) and cryopreservation (-196C) of human cells and tissues. The HTS platform consists of HTS-BASE, HTS-DCC, HTS-FRS and other custom preservation solutions currently being designed for clients in the Regenerative Medicine market. BioLife's CryoStor cryopreservation solution platform is designed for storage of cells and tissues in liquid nitrogen without serum and with reduced levels of DMSO. BioLife's solutions are designed by first understanding the molecular details of cell death cascades that can be prematurely launched as a consequence of hypothermic storage or cryopreservation. Once known, solution formulation is altered in such a manner that inhibits these cell death processes. BioLife's HTS-FRS is superior to UW Solution (ViaSpan) - the solution currently being used for most human organ storage. Similarly, BioLife's CryoStor series may be better at cryopreservation than the current ATCC industry protocol. BioLife's solutions are now a part of BioHeart's FDA-approved IND in cellular cardiomyoplasty - a successful international program in cardiac Regenerative Medicine made possible, in part, by BioLife's HTS-FRS. This Phase II proposal is dedicated to the improved hypothermic and cryopreservation of human blood vessels. BioLife has teamed with CryoLife Inc., a major supplier of preserved, allograft vascular prostheses, so that improved preservation solutions can be developed that (1) do not necessitate the current inclusion of serum and chondroitin sulfate and (2) harness BioLife's recent research on the role of apoptosis in preservation failure so that outcome is improved in the transplant of preserved allograft vessels. The Specific Aims of this proposal include the following: (1) Determine if the improvement in viability of cells stored in HTS and CryoStor solutions relative to ViaSpan is mirrored by a similar improvement in function; (2) Test the inclusion of other agents that modulate apoptosis for their potential abilities to improve HTS and CryoStor efficacy; (3) Determine if applying the Ciphergen ProteinChip system can be used for either high throughput assessment of HTS and CryoStor variants and/or determining whether preserved vessels are contaminated with bacterial enterotoxins and (4) test for natural factors that may confer unusual hypothermic resilience in cells.