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

组织快速自动化制造 (RAFT)：角膜干细胞

• 批准号: 100555
• 金额: $ 68.87万
• 依托单位: THE AUTOMATION PARTNERSHIP (CAMBRIDGE) LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2008
• 资助国家: 英国
• 起止时间: 2008 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=100555
• 关键词: Rapid; Automated; Fabrication; Tissues; RAFT

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.

Tap Biosystems和UCL眼科研究所正在开发一种新颖的专利技术（RAFT），该技术可以简单且可重复地从胶原蛋白制造3D组织等效物。筏过程创建了我们用来开发角膜疗法的组织样结构 - 带有压花的表面拓扑结构以复制体内干细胞小裂，以支持眼表面再生。结果非常有前途；我们可以将具有形态学和蛋白质标记物的多层眼上皮形成，就像正常的人角膜一样。我们进行了高级临床前工作，定义了安全测试，监管途径和QC分析的基础。我们在该项目中的目的是完成临床前测试，获得法规和道德批准，然后在GMP条件下制造治疗，并根据特种医院的豁免安排在Moorfields Eye Hospital进行小型男子安全研究。这项研究的数据将使我们能够迈向I/II期临床试验。