Service d'Ophtalmologie, Hôpital Edouard Herriot, 5 Place d'Arsonval, 69 437 Lyon Cedex 03, France.
Invest Ophthalmol Vis Sci. 2012 Mar 13;53(3):1325-31. doi: 10.1167/iovs.11-7744.
Total bilateral corneal limbal epithelial stem cell deficiency (LSCD) cannot be treated with the surgical transplantation of autologous limbus or cultured autologous limbal epithelium. Transplantation of allogenic limbal epithelium is possible but requires immunosuppressive treatments. Cultured autologous oral mucosal epithelial cell sheet (CAOMECS) is a transparent, resistant, viable, and rapidly bioadhesive cell sheet, cultured with the UpCell-Insert technology (CellSeed, Inc., Tokyo, Japan), which allows for grafting onto the patient's corneal stroma without suturing. It has therefore been proposed as an alternative treatment for LSCD.
The objectives were to assess the safety and efficacy of CAOMECS, using a prospective Gehan's design. Safety was measured in terms of ocular adverse events during the study period, and efficacy was measured using a composite criterion based on epithelial defect, punctate epithelial keratopathy, conjunctival epithelium on the cornea, number of vascular pediculi, and vessel activity.
CAOMECS was found to be safe and effective. In total, 26 eyes of 25 patients received a graft. Two patients experienced serious adverse events classified as not product related. Twenty-five patients were included in the efficacy analysis, as one patient was lost to follow-up. The treatment was found to be effective in 16 of 25 patients at 360 days after grafting. Of the 23 patients who completed follow-up at 360 days, 22 had no ulcers, and 19 showed a decrease in the severity of the punctate epithelial keratopathy.
CAOMECS is a well-tolerated and safe tissue-engineered product. These results suggest its efficacy for reconstructing the ocular surface in patients with total bilateral corneal LSCD.
双侧全角膜缘上皮干细胞缺乏症（LSCD）不能通过自体角膜缘或培养的自体角膜缘上皮的外科移植来治疗。同种异体角膜缘上皮移植是可能的，但需要免疫抑制治疗。培养的自体口腔黏膜上皮细胞片（CAOMECS）是一种透明、有抗性、有活力且快速生物附着的细胞片，使用 UpCell-Insert 技术（CellSeed，Inc.，东京，日本）培养，可以在不缝合的情况下移植到患者的角膜基质上。因此，它被提议作为 LSCD 的替代治疗方法。
本研究采用前瞻性 Gehan 设计，评估 CAOMECS 的安全性和疗效。安全性通过研究期间眼部不良事件来衡量，疗效通过基于上皮缺损、点状上皮角膜炎、角膜上的结膜上皮、血管蒂的数量和血管活性的综合标准来衡量。
CAOMECS 被发现是安全有效的。总共 25 例患者的 26 只眼接受了移植。两名患者发生了严重不良事件，归类为与产品无关。25 例患者纳入疗效分析，1 例患者失访。在移植后 360 天，25 例患者中有 16 例被发现治疗有效。在完成 360 天随访的 23 例患者中，22 例无溃疡，19 例点状上皮角膜炎的严重程度有所下降。
CAOMECS 是一种耐受性良好且安全的组织工程产品。这些结果表明，它在治疗双侧全角膜 LSCD 患者的眼表面方面具有疗效。
