Takayanagi Hiroshi, Hayashi Ryuhei
Research, Development and Production Department of RAYMEI Incorporated, Osaka, Japan.
Department of Ophthalmology, Osaka University Graduate School of Medicine, Osaka, Japan.
Regen Ther. 2024 Sep 17;26:819-825. doi: 10.1016/j.reth.2024.09.001. eCollection 2024 Jun.
Among the regenerative therapies being put into clinical use, the field of corneal regenerative therapy is one of the most advanced, with several regulatory approved products. This article describes the progress from initial development through to clinical application in the eye field, with a particular focus on therapies for corneal epithelial and endothelial diseases that have already been regulatory approved as regenerative therapy products. The applications of regenerative therapy to the corneal epithelium were attempted and confirmed earlier than other parts of the cornea, following advancements in basic research on corneal epithelial stem cells. Based on these advances, four regenerative therapy products for corneal epithelial disease, each employing distinct cell sources and culture techniques, have been commercialized since the regulatory approval of Holoclar® in Italy as a regenerative therapy product for corneal epithelial disease in 2015. Corneal endothelial regenerative therapy was started by the development of an method to expand corneal endothelial cells which do not proliferate in adults. The product was approved in Japan as Vyznova® in 2023. The development of regenerative therapies for retinal and ocular surface diseases is actively being pursued, and these therapies use somatic stem cells and pluripotent stem cells (PSCs), especially induced pluripotent stem cells (iPSCs). Accordingly, the eye field is anticipated to play a pioneering role in regenerative therapy development going forward.
在已投入临床使用的再生疗法中，角膜再生治疗领域是最先进的领域之一，有多种获得监管批准的产品。本文描述了从最初研发到眼科临床应用的进展，特别关注已作为再生治疗产品获得监管批准的角膜上皮和内皮疾病的治疗方法。随着角膜上皮干细胞基础研究的进展，角膜再生治疗在角膜上皮的应用比角膜其他部位更早进行尝试并得到证实。基于这些进展，自2015年意大利批准Holoclar®作为角膜上皮疾病的再生治疗产品以来，四种用于角膜上皮疾病的再生治疗产品已实现商业化，每种产品采用不同的细胞来源和培养技术。角膜内皮再生治疗始于一种扩大成年后不再增殖的角膜内皮细胞的方法的开发。该产品于2023年在日本获批为Vyznova®。视网膜和眼表疾病再生疗法的研发正在积极推进，这些疗法使用体干细胞和多能干细胞（PSC），尤其是诱导多能干细胞（iPSC）。因此，预计眼科领域在未来的再生治疗发展中将发挥先锋作用。
