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.

总结 先前来自NIH SBIR和库尔特基金会的支持使CryoCrate团队能够开发出第一个- 商标为OdinSol®的同类生物相容性冷冻保存介质产品，其将提供有效的 与供体皮肤移植物或异种移植物的储存相关的生物库实践的选择。 OdinSol®技术消除了所有现有冷冻设备中使用的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， 通过防止细胞逐渐损失，在常规-80 ° C深冻箱中长期储存的结果。 根据我们之前在FDA 510（k）提交方面的经验，在本项目中，我们组织了与 我们的监管顾问（Cardinal Health）、合同生产组织（Bryllan）、合同研究 组织（WuXi AppTec），学术合作者（密苏里州大学医学部和国家 猪研究和研究中心），以实现以下里程碑： I. OdinSol®的生产符合GMP资格和生物相容性评估表明 符合FDA关于作为可移植组织储存器械提交510（k）的指南; 二.安全性和有效性的体外和体内评价证明OdinSol®技术是 在保存皮肤的活力和功能方面上级现有的低温保存方案 移植物; 三.根据这些资格，我们将完成510（k）提交并完成生产 在项目期结束前，根据林业发展局的进一步反馈， 我们预计OdinSol®技术将在FDA批准后三年内投入临床使用， 皮肤银行和异种移植行业的高效生物相容性冷冻储存平台。