A Novel Cryopreservation Technology for Large Skin Grafts to Facilitate Tissue Banking and Allograft Transplantations

SUMMARY As a result of recent and rapid advances of immunogenetical, artificial intelligence (AI) and big data technologies, the accuracy and efficiency of donor-recipient immunogenetical matching are expected to be significantly improved. As such, traditional tissue banking practices are being severely challenged due to low cryopreservation throughput. Skin allograft transplantations are currently utilized for numerous clinical applications. In such applications, donor tissues are now typically utilized as “expensive bandages”, i.e. for temporary coverage, thereby requiring painful and damaging follow-on autotransplantation procedures. With tremendously improved skin graft cryopreservation methods coupled with use of HLA matching based on AI network, future tissue banking platforms can potentially provide grafts to be used as permanent and definitive treatment for patients, thereby bringing high impact to clinical applications and the healthcare industry. Based on CryoCrate’s novel ultra-fast (106 K/min on a sample surface) cooling technology platform (PCT/US2019/26162), this project aims to develop a highly efficient (approaching 100% post-thaw viability) tissue graft cryopreservation prototype system that requires no cryoprotectant. The post-thaw viability and functionality will be assessed by standard in vitro assays using porcine and human skin (research exempt) grafts and in vivo assays using a mouse model. After achieving these aims, in future phase II and III stages, CryoCrate and its academic collaborator will collaborate with a local Organ Procurement Organization (Mid-America Transplant) and a wound healing clinic (University of Missouri Hospital) for porcine and human skin transplantation studies and clinical trials.Narrative A novel skin graft cryopreservation technology that requires no cryoprotectant will be developed to significantly improve efficiencies for tissue banking and allograft transplantation practices. This project initiates collaboration between CryoCrate LLC and local stakeholders, and thereby paves a path to commercialization of a new generation of ultra‐fast tissue cryopreservation devices.