An Ultra-fast Cooling Device for Vitrification and Cryopreservation of Cells and Tissues

总结 CryoCrate LLC（www.CryoCrate.com）的使命是开发新的平台低温保存技术 用于生命科学和临床实践。随着近年来基于细胞的组织工程的快速发展， 和再生医学，以及移植技术的持续发展， 迫切需要临床实用的方法和有效的装置来冷冻保存大量的 生物人工组织和供体组织。在该项目的第一阶段，我们成功地建立了一个新颖的超快速 小组织的冷却方法（在细胞水平上为106 K/min）。在第二阶段，我们将：1）设计一个 升级的设备系统，实现了整个角膜和大型角膜的冷冻保存相同的效率 生物人工组织并促进其临床和研究用途; 2）通过以下方式将器械生产为成熟产品： 与专业制造商（Gateway Discovery Products LLC）和cGMP顾问（Cardinal）合作 健康）;和3）测试角膜和生物人工视网膜组织的解冻后体外活力和功能， 并对兔子进行体内动物研究（UMKC视觉研究中心）。实现这些目标后， 里程碑，我们将与我们的眼库合作者（拯救视力），目前的经销商（五月花生物科学）， 和潜在的战略合作伙伴（赛默飞世尔科技），将该产品引入角膜移植， 组织工程市场。

Summary The mission of CryoCrate LLC (www.CryoCrate.com) is to develop new platform cryopreservation technologies for applications in life science and clinical practice. With recent rapid advances in cell-based tissue engineering and regenerative medicine, as well as continued development of transplantation technologies, there has always been an urgent need for clinically practical methods and efficient devices for cryopreservation of large stocks of bioartificial and donor tissues. In the Phase I period of this project, we successfully established a novel ultra-fast cooling method (106K/min on cellular level) for small tissues. In the Phase II period, we will: 1) design an upgraded device system that achieves the same efficiency for cryopreservation of the whole corneas and large bioartificial tissues and facilitate their clinical and research use; 2) produce the device as a mature product by working with a professional manufacturer (Gateway Discovery Products LLC) and cGMP consultant (Cardinal Health); and 3) test the post-thaw in-vitro viability and functionalities of the corneas and bioartificial retinal tissues, and conduct in-vivo animal studies on rabbits (Vision Research Center at UMKC). After achieving these milestones, we will work with our eye bank collaborator (Saving Sight), current distributor (Mayflower Bioscience), and potential strategic partner (Thermo Fisher Scientific) to introduce the product to corneal transplantation and tissue engineering markets.