Establishing Process Control for the Manufacturing of Corneal Tissues in Clinical Applications

建立临床应用中角膜组织制造的过程控制

• 批准号: 2299854
• 金额: --
• 依托单位: Loughborough University
• 依托单位国家: 英国
• 项目类别: Studentship
• 财政年份: 2018
• 资助国家: 英国
• 起止时间: 2018 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=studentship-2299854
• 关键词: Establishing; Process; Control; Manufacturing; Corneal

There are approximately 1.5 million cases of corneal blindness diagnosed annually and 10 million untreated patients worldwide. Presently, worldwide shortages of donated corneal tissues warrant the need for alternative engineered solutions. There is also an immediate demand to verify the condition of all donated tissues such that it can be deemed viable for transplantation. Once the initial state has been determined, subsequent processes including transportation, storage and preparations for use, can be examined to determine if at any stage damage is inflicted upon the tissue. We need to establish robust measures since current protocols lack manufacturing controls necessary to create a reproducible manufacturing process suitable for regular clinical application. This requires the development of novel quantitative characterisation tools to measure primarily the quality of input materials, with the ultimate aim to develop a capability to measure and quantify downstream processing techniques. This will allow for the determination of defined tissue specifications, and a system capable of auditing donor tissue to determine its suitability for transplantation. In order to determine design specifications, an audit of healthy versus non-healthy corneal tissues will be performed in conjunction with Leicester Royal infirmary Hospital.Such a capability enables tissue-engineering processes to be examined including decellurisation, which has the potential for recycling corneal tissues deemed unsuitable for transplantation as partial thickness grafts. The use of laser speckle interferometric instruments has recently been shown to provide a near instantaneous means of mechanically measuring corneal properties and defining the suitability of corneal tissue. This project seeks to extend this work, establish process controls and examine the potential for diagnosing early onset corneal issues such as keratoconus.

全世界每年约有150万例角膜失明被诊断出来，1000万患者未经治疗。目前，世界范围内捐献角膜组织的短缺保证了对替代工程解决方案的需求。目前还迫切需要核实所有捐赠组织的状况，使其能够被认为适合移植。一旦确定了初始状态，就可以检查随后的过程，包括运输、储存和使用准备，以确定是否在任何阶段对组织造成损害。我们需要建立稳健的措施，因为目前的方案缺乏必要的制造控制，无法创建适合常规临床应用的可重复制造工艺。这需要开发新的定量表征工具，主要用于测量输入材料的质量，最终目标是开发测量和量化下游加工技术的能力。这将允许确定已定义的组织规格，以及能够审核供体组织以确定其移植适用性的系统。为了确定设计规范，将与莱斯特皇家医院联合进行健康与非健康角膜组织的审计。这种能力使组织工程过程可以被检查，包括脱细胞，这有可能回收被认为不适合移植的角膜组织作为部分厚度的移植物。激光散斑干涉测量仪器的使用最近被证明提供了一种近乎瞬时的机械测量角膜特性和确定角膜组织适用性的方法。本项目旨在扩展这项工作，建立过程控制并检查诊断早期角膜问题（如圆锥角膜）的潜力。