Innovation of Skin Banking and Transplantation Based on a First-in-Class Biocompatible Cryopreservation Technology

基于一流的生物相容性冷冻保存技术的皮肤库和移植创新

• 批准号: 10618957
• 负责人: Xu Han
• 金额: $ 73.63万
• 依托单位: CRYOCRATE, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-06 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10618957
• 关键词: American; Artificial Intelligence; Attributes of Chemicals; Autologous Transplantation; Award; Bandage; Big Data; Biological Assay; Birth; Cells; Chemicals; Clinical; Collaborations; Collagen; Contracts; Coupled; Cryopreservation; Cryopreserved Tissue; DNA Sequence Alteration; Data Set; Devices; Dimethyl Sulfoxide; Domestic Pig; Electrons; Enzyme-Linked Immunosorbent Assay; Evaluation; Family suidae; Feedback; Foundations; Future; Glycerol; Goals; Good Manufacturing Process; Growth Factor; Health; Healthcare Industry; Histology; Human; Immunogenetics; In Situ Nick-End Labeling; In Vitro; Industrialization; Industry; Knock-out; Letters; Marketing; Medicine; Methods; Microscopic; Missouri; Organ Procurements; Osmosis; Outcome; Procedures; Process; Production; Protocols documentation; Qualifying; Research; Research Contracts; Resources; Safety; Secure; Skin; Skin Transplantation; Skin graft; Small Business Innovation Research Grant; Stains; Standardization; Technology; Testing; Tissue Banks; Tissue Donors; Tissue Procurements; Tissue Transplantation; Tissue Viability; Toxic effect; Trademark; Transplantation; United States National Institutes of Health; Universities; Work; Xenograft procedure; biobank; biomaterial compatibility; clinical care; commercial prototype; commercialization; efficacy evaluation; evaluation/testing; experience; healing; improved; in vivo; in vivo Model; in vivo evaluation; innovation; invention; manufacturing organization; medical schools; novel; operation; preservation; prevent; small molecule

SUMMARY Previous support from NIH SBIR and Coulter Foundation awards allowed the CryoCrate team to develop a first- in-class biocompatible cryopreservation medium product, trademarked as OdinSol®, that will provide efficient options for biobanking practices associated with storage of skin grafts from donors or xenotransplants. The OdinSol® technology removes the need for any toxic cell permeating cryoprotectant used in all existing tissue cryopreservation methods, considerably simplifies associated operations, and more importantly, secures the outcome of long-term storage in regular -80oC deep freezers by preventing gradual cell loss. Based on our former experience in FDA 510(k) submission, in this project, we organized the collaboration with our regulatory consultant (Cardinal Health), contract manufacturing organizations (Bryllan), contract research organization (WuXi AppTec), academic collaborator (University of Missouri Department of Medicine and National Swine Research and Research Center), to achieve the following milestones: I. The production of OdinSol® meets GMP qualifications and biocompatibility assessment shows compliance with FDA guidance for 510(k) submission as a storage device for transplantable tissues; II. The in vitro and in vivo evaluation of safety and efficacy demonstrates the OdinSol® technology to be superior to existing cryopreservation protocols with respect to preserving viability and function of skin grafts; III. Based on those qualifications, we will complete of the 510(k) submission and finalize of the production line based on further FDA feedback before the end of the project period. We expect future clinical use of the OdinSol® technology within three years after the FDA clearance, providing the skin banking and xenotransplantation industry with a highly efficient biocompatible cryostorage platform.

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