Rapid Automated Fabrication of Tissues (RAFT): Corneal Stem Cells

TAP Biosystems和UCL眼科研究所正在开发一种新的专利技术（RAFT），该技术能够简单且可重复地从胶原蛋白中制造3D组织等效物。RAFT过程创建了一个组织样的架构，我们正在使用它来开发角膜治疗-具有浮雕表面拓扑结构以复制体内干细胞生态位-以支持眼表面再生。结果非常有希望;我们可以可重复地制造具有与正常人角膜非常相似的形态和蛋白质标记的多层眼上皮。我们有先进的临床前工作，定义安全性测试，监管途径和QC检测的基础。我们在该项目中的目标是完成临床前测试，获得监管和伦理批准，然后在GMP条件下生产治疗药物，并根据特殊医院豁免安排在Moorfields眼科医院进行小型首次人体安全性研究。这项研究的数据将使我们能够进展到I/II期临床试验。

TAP Biosystems and UCL Institute of Ophthalmology are developing a novel, patented technology (RAFT) that enables 3D tissue equivalents to be manufactured from collagen simply and reproducibly. The RAFT process creates a tissue-like architecture that we are using to develop a corneal therapy - with embossed surface topology to replicate the in vivo stem cell niche - to support ocular surface regeneration. Results are very promising; we can reproducibly make multilayered ocular epithelia with morphology and protein markers very like the normal human cornea. We have advanced preclinical work, defining safety testing, regulatory pathway and the basis for QC assays. Our aim in this project is to complete preclinical testing, obtain regulatory and ethical approval, then manufacture the therapy in GMP conditions and perform a small first in man safety study at Moorfields Eye Hospital under Specials Hospitals Exemption arrangements. The data from this study would enable us to progress towards phase I/II clinical trials.