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

一种用于大型皮肤移植物的新型冷冻保存技术，以促进组织库和同种异体移植

• 批准号: 10011745
• 负责人: Xu Han
• 金额: $ 16.04万
• 依托单位: CRYOCRATE, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-12 至 2022-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10011745
• 关键词: Allografting; Americas; Animal Model; Area; Artificial Intelligence; Autologous Transplantation; Bandage; Big Data; Biological Assay; Clinic; Clinical; Clinical Trials; Collaborations; Communities; Coupled; Cryopreservation; Cryopreserved Tissue; Devices; Engineering; Excision; Family suidae; Freeze Drying; Freezing; Fresh Tissue; Future; Gases; Generations; Goals; Healthcare Industry; Hospitals; Human; Immunogenetics; Impairment; In Situ Nick-End Labeling; In Vitro; Liquid substance; Mechanics; Methods; Missouri; Modeling; Mus; Nitrogen; Organ Procurements; Outcome; Pain; Patients; Performance; Phase; Procedures; Process; Research; Research Project Grants; Sampling; Skin; Skin Tissue; Skin Transplantation; Skin graft; Stains; Surface; System; Technology; Testing; Thick; Thinness; Time; Tissue Donors; Tissue Grafts; Tissue Transplantation; Tissues; Toxic effect; Transplantation; Universities; Variant; base; biobank; clinical application; commercialization; design; experimental study; improved; in vitro Assay; in vivo; invention; medical schools; mouse model; novel; prototype; scale up; skin allograft; success; transplant model; two-dimensional; wound healing

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.

概括 由于免疫原性，人工智能（AI）和Big的最新进展和快速进步 数据技术，供体 - 复发免疫原性匹配的准确性和效率是 预计将得到显着改善。因此，传统的组织银行业务正在 由于冷冻保存吞吐量低而受到严重挑战。皮肤同种异体移植是 目前用于众多临床应用。在这种应用中，现在是供体组织 通常用作“昂贵的绷带”，即用于临时覆盖范围，从而需要痛苦 以及损害后续自动移植程序。具有大量改善的皮肤移植 冷冻保存方法，加上基于AI网络的HLA匹配，未来组织 银行平台可能会提供成绩，以用作永久和确定的治疗 对于患者，从而对临床应用和医疗保健行业产生了巨大影响。 基于低温者的新型Ultra-fast（样品表面上的106 K/min）冷却技术 平台（PCT/US2019/26162），该项目旨在开发高效（接近100％ 透射后的生存能力）组织草冷冻保存原型系统，不需要冷冻注视剂。 疗程后的生存能力和功能将通过标准的体外评估来评估猪 和人类皮肤（研究豁免）移植物和使用小鼠模型的体内测定。后 在未来的第二阶段和III阶段实现这些目标及其学术合作者 将与当地的器官采购组织（中美洲移植）和一个合作 伤口愈合诊所（密苏里大学医院）用于猪和人类皮肤移植 研究和临床试验。