Ice-free vitrification and nano warming technology for banking of cardiovascular structures.

ABSTRACT This diversity administrative supplement proposal is focused on obtaining postdoctoral support for an outstanding individual, Dr. Fred Xavier, to work on our Phase II SBIR grant directed at translation of ice-free cryopreservation by vitrification employing a novel approach of volumetric heating by nanowarming using Fe nanoparticles in an

alternating electromagnetic field and be trained in small business entrepreneurship. Vitrification, sub-zero storage below the glass transition temperature in a “glassy” rather than a crystalline frozen phase, is a form of cryopreservation that avoids ice formation. There are 3 specific aims in which we will employ porcine vascular models in a combination of ex vivo and in

vivo studies. Dr. Xavier will be involved in all three aims with emphasis on biomechanics, surgery, histopathology, presentations, publications with training in all business aspects including customer outreach. His work will be supervised by a multidisciplinary Advisory Oversight Committee consisting of faculty from Tissue Testing

Technologies LLC (T3LLC), Clemson University, Medical University of South Carolina, and Imperial College, London, with Dr. Brockbank training him in business issues related to operating a small business. In Aim 1 we will evaluate cryopreserved arteries after real time shipping, comparing methods and validating the

transport conditions that are finally approved based upon absence of tissue cracking. In Aim 2 we will characterize the post-ice-free cryopreservation state of arteries preserved for at least 2-years. In addition, during this aim we will characterize the chemistry and biomaterial properties of ice-free cryopreserved blood vessels.

In Aim 3 we will perform short-term transplant studies (28 days) in two porcine vascular models (femoral and pulmonary artery into the carotid and pulmonary, respectively) in order to validate our technology for a future Phase IIb SBIR proposal using clinically relevant preclinical non-human primate models and human tissues. At

the conclusion of these aims it is anticipated that Dr. Xavier will have the necessary tools to establish himself as a successful independent clinical investigator and become an entrepreneur.