< Relevant articles > Please go to PubMed here. Aketa, N., Kasai, M., Noda, S., Asano, J., Kunieda, A., Kawanishi, S., Maruyama, Y. & Honda, F. Insights into the clinical development of regenerative medical products through a comparison of three cell-based products recently approved for limbal stem cell deficiency. Ocul Surf 29, 220-5 (2023). 10.1016/j.jtos.2023.05.008 < Backgrounds > Between 2020 and 2022, 3 regenerative medical products (Nepic, Ocural, and Sakracy) for limbal stem cell deficiency* clinical development of regenerative medical products internationally from the viewpoint of a regulatory agency by organizing points to consider in review for these products in a cross-sectional manner. < Outline> All the three products are sheet-like cultured products using the cells collected from the patients themselves. The raw are derived from the autologous oral mucosal tissue. Human amnion membrane is used as the substrate for Sakracy. In addition, for limbal stem cell deficiency*, which is an intractable and rare disease, Nepic and Ocural were developed for the purpose of corneal tissue reconstruction, while Sakracy was developed for the treatment of adhesions associated characteristics and intended use, different indications were set for each product. Regenerative medical products are often developed for rare diseases, etc. for which treatment methods and appropriate endpoints have not been established, and examples of reference are limited. For this reason, unlike usual drug development, various unknown issues must be resolved through a series of trials and errors from the development phases to the review. It is important to continue scientific discussions between developers and regulatory authorities from the early stage of development in order to promote appropriate development. Office of Cellular and Tissue-based Products, Shinichi Noda 21 * A disease in which the cornea is covered with conjunctival epithelium or connective tissues due to damage to corneal epithelial stem cells, resulting in reduced visual acuity or adhesion of the ocular surface. The conventional therapy of limbal keratoplasty is known to have problems such as lack of donor cornea and high invasiveness. were approved one after another in Japan. It was the first time in the world that multiple cell-based medical products were approved for the same ocular disease. Therefore, PMDA decided to disseminate the current status and prospects of materials of Nepic are derived from the autologous corneal limbus tissues, and the raw materials of Ocural and Sakracy with limbal epithelial stem cell deficiency*. As a result of the review based on the differences in the above product recently approved for limbal stem cell deficiency Insights into the clinical development of regenerative medical products through a comparison of three cell-based products
元のページ ../index.html#21