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

摘要 之前获得NIH SBIR和库尔特基金会奖的支持使CryoCrate团队能够开发出第一个- 同类生物兼容冷冻保存介质产品，商标为OdinSol®，将提供高效的 与储存供者皮肤移植物或异种移植皮肤相关的生物库做法的选择。 OdinSol®技术消除了在所有现有设备中使用任何有毒细胞渗透冷冻保护剂的需要 组织冷冻保存方法，大大简化了相关操作，更重要的是，确保了 通过防止细胞逐渐流失，在常规-80oC超低温冰箱中长期储存的结果。 基于我们以前在FDA 510(K)提交方面的经验，在这个项目中，我们组织了与 我们的监管顾问(Cardinal Health)、代工组织(Bryllan)、合同研究 组织(无锡AppTec)，学术合作者(密苏里大学医学部和国家 猪研究和研究中心)，以实现以下里程碑： I.OdinSol®的生产符合GMP资格和生物兼容性评估显示 遵守FDA关于提交510(K)作为可移植组织储存装置的指南； 体外和体内的安全性和有效性评估表明，OdinSol®技术是 在保存皮肤活力和功能方面优于现有的冷冻保存方案 移植物； 根据这些资格，我们将完成510(K)提交并最终确定产品 在项目期结束之前，应根据FDA的进一步反馈确定项目。 我们预计在FDA批准后三年内，OdinSol®技术将在临床上使用，提供 为皮肤库和异种移植行业提供高效的生物兼容冷冻存储平台。

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.