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The aims of this study were to investigate the premarket assessment of autologous chondrocyte implantation (ACI) products especially regarding the non-clinical assessment by surveying the guidelines and review reports of authorized ACI products in detail and to provide information regarding the non-clinical assessment of the safety and efficacy for the future development of regenerative medicine products to design effective premarket assessment. The non-clinical assessment plays a role in justifying the testing of investigational products in humans. Effective non-clinical assessments minimize the risk of clinical trials and achieve prompt product development. In this study, we focused on authorized ACI products that remain in the body of patients for a long time and often contain extrinsic components such as animal tissue-derived collagen. We summarized the details of the characteristics of each ACI product, non-clinical assessment design and related guidelines. To design effective non-clinical assessments, we discussed the evaluation method (particularly the validation of clinical assessment and mechanical property testing), the employed animal models, and the differences in the assessment of the safety and efficacy of the products. Based on these investigations, we provide the details of satisfactory non-clinical assessment of ACI products and indicate the possibility of more effective non-clinical assessment of ACI products and other future regenerative medicine products.

Non-clinical assessment design of autologous chondrocyte implantation products