Nepic Human (autologous) corneal limbus-derived corneal epithelial cell sheet March 26, 2020 Japan Tissue Engineering Co., Ltd. Open-label, uncontrolled study Success rate of corneal epithelial reconstruction Limbal stem cell deficiency (Stage II and III in severity) Note that patients in whom the causative disease is an intrinsic factor such as Stevens-Johnson syndrome are excluded. (Table 2 of Ocul Surf 29, 220-5 (2023)) Ocural Human (autologous) oral mucosa-derived epithelial cell sheet June 11, 2021 Limbal stem cell deficiency (Stage II and III in severity) Sakracy Human (autologous) oral mucosa-derived epithelial cell sheet using amniotic membrane substrate January 20, 2022 Hirosaki Lifescience Innovation, Inc. Adhesion score Alleviating adhesion on the ocular surface in limbal stem cell deficiency (All stages in severity) 22 < Impact on RS, expectations > This paper will present the views of regulatory authorities in the review of regenerative medical products and widely disseminate the necessity of close discussions between developers and regulatory authorities from the early stage of development in order to overcome development issues, which may be a help to promote future development of regenerative medical products. Comparison of 3 regenerative medical products in patients with limbal stem cell deficiency Brand name Generic Name Approval Date Applicant Clinical trial design Primary endpoint Approved indications
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