Wake Forest Institute of Regenerative Medicine , Winston Salem, North Carolina.
Tissue Eng Part C Methods. 2017 Dec;23(12):926-937. doi: 10.1089/ten.TEC.2017.0181. Epub 2017 Sep 8.
Procedures for the evaluation of tissue-engineering processes, including those used for the testing of the relevant biomaterials, have not been developed in a logical manner. This perspectives paper discusses the limitations of testing regimes and recommends a very different approach. The main emphasis is on the existing methods for assessing the biological safety of these biomaterials, which, it is suggested, are irrelevant for evaluating materials that are intended to facilitate the generation of new tissue. An algorithm is proposed that sets out the pathway from materials design and characterization through to the production of a file that sets out full biocompatibility, functionality, and tissue incorporation data that are suitable for regulatory consideration for first-in-man experiences. Central to this algorithm is the choice of animal models and the real-time monitoring of the implanted construct performance.
组织工程过程的评估程序，包括用于测试相关生物材料的程序，尚未以逻辑方式开发。本文讨论了测试方案的局限性，并建议采用一种截然不同的方法。主要重点是评估这些生物材料生物安全性的现有方法，这些方法被认为与评估旨在促进新组织生成的材料不相关。提出了一种算法，该算法从材料设计和特性描述开始，一直到生成文件，该文件列出了完全生物相容性、功能和组织整合数据，这些数据适合监管部门考虑用于人体首次试验的经验。该算法的核心是动物模型的选择和植入构建性能的实时监测。
