Tensile Testing of Cultured Epidermis

Introduction

Various research institutes and businesses have been developing regenerative medical products in the recent years in order to facilitate the spread of regenerative medicine. Since quality control is crucial for regenerative medical products, various material has been issued by the Pharmaceuticals and Medical Devices Agency (PMDA) which conducts reviews. Although the issued material calls for dynamic evaluations in addition to biological evaluations, they do not include a description of specific evaluation methods. Dynamic evaluation was conducted upon transplanting iPS cell-derived retinal pigment epithelial cell sheets, but the evaluation method was no more than qualitative, consisting of only checks for damage at the time of graft preparation. However, quantitative evaluations will likely be necessary for cell sheets which require mechanical strength such as cultured skin sheets and myocardial cell sheets. Furthermore, unlike the current regenerative medical products using autologous cells, it is possible that regenerative medical products using allogeneic cells, which are expected to become mainstream in the future, will be required to observe specification tests based on quantitative quality standards. In this research, tensile tests were performed using cultured epidermis, which is a regenerative medical product, and milk membrane imitating cultured epidermis (collected from the surface of hot milk) as an example of a quantitative evaluation of a material's mechanical properties.

December 4, 2017 GMT