Abstract
A novel regenerative medicine product for limbal stem cell deficiency （LSCD） with ocular surface adhesions is progressed in clinical application since 2023. This ophthalmologic surgery, transplantation of cultivated autologous oral mucosal epithelial cell sheet using human amnion membrane substrate, had been researched and developed by ophthalmologists of an academic institute, Kyoto Prefectural University of Medicine. According to the results of phase 3 investigator-initiated clinical trial, we, Hirosaki-LI Inc., received the manufacturing and sales approval of this product from Japan regulatory agency. A high insurance reimbursement price was obtained through accounting cost calculation, it is due to the evaluation of the novelty of this treatment method. This accomplishment, an unlisted company obtained approval to manufacture and sell regenerative medicine products, is the first time in Japan. Furthermore, its clinical application and business has been successfully progressing. The fact appears to be a remarkable model case for social implementation of university-originated technology.
