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

摘要 CryoCrate LLC(www.CryoCrate.com)的使命是开发新的平台冷冻保存技术 应用于生命科学和临床实践。随着最近基于细胞的组织工程的快速发展 而再生医学，以及移植技术的不断发展，一直存在 迫切需要临床上实用的方法和有效的设备来超低温保存大量的库存 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种新型的超快 小组织的降温方法(细胞水平上的106K/分钟)。在第二阶段，我们将：1)设计一个 升级的设备系统，实现了对整个角膜和大片角膜的同等效率的冷冻保存 生物人工组织并促进其临床和研究使用；2)通过以下方式将该设备作为成熟产品生产 与专业制造商(Gateway Discovery Products LLC)和cGMP顾问(Cardinal 健康)；以及3)测试角膜和生物人工视网膜组织解冻后的体外活性和功能， 并在兔身上进行活体动物研究(UMKC视觉研究中心)。在实现这些目标之后 里程碑，我们将与眼库合作者(Saving Sight)、当前分销商(五月花生物科学公司)、 和潜在的战略合作伙伴(Thermo Fisher Science)将该产品引入角膜移植和 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.