Cultured Autologous Oral Mucosal Epithelial Cell Sheet (CAOMECS) Transplantation for the Treatment of Corneal Limbal Epithelial Stem Cell Deficiency
Cultured Autologous Oral Mucosal Epithelial Cell Sheet (CAOMECS) Transplantation for the Treatment of Corneal Limbal Epithelial Stem Cell Deficiency
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DOI：
10.1167/iovs.11-7744
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发表时间：
2012-03-01
影响因子：
4.4
通讯作者：
Damour, Odile
中科院分区：
文献类型：
--
作者：
Burillon, Carole;Huot, Laure;Damour, Odile
目的。双侧角膜缘上皮干细胞完全缺乏症（LSCD）不能通过手术移植自体角膜缘或培养的自体角膜缘上皮来治疗。同种异体角膜缘上皮移植是可能的，但需要免疫抑制治疗。培养的自体口腔粘膜上皮细胞片 (CAOMECS) 是一种透明、有抵抗力、有活力且快速生物粘附的细胞片，采用 UpCell-Insert 技术（CellSeed, Inc.，东京，日本）培养，无需缝合即可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。目的是使用前瞻性 Gehan 设计评估 CAOMECS 的安全性和有效性。根据研究期间的眼部不良事件来衡量安全性，并使用基于上皮缺损、点状上皮性角膜病变、角膜结膜上皮、血管蒂数量和血管活动的综合标准来衡量疗效。 结果。 CAOMECS 被证明是安全有效的。总共有 25 名患者的 26 只眼睛接受了移植手术。两名患者经历了与产品无关的严重不良事件。功效分析中纳入了 25 名患者，其中一名患者失访。移植后 360 天，该治疗对 25 名患者中的 16 名有效。在 360 天完成随访的 23 名患者中，22 名患者没有出现溃疡，19 名患者点状上皮角膜病变的严重程度有所减轻。 结论。 CAOMECS 是一种耐受性良好且安全的组织工程产品。这些结果表明其对于双侧全角膜 LSCD 患者眼表重建的功效。 （投资眼科可见科学 2012；53：1325-1331）DOI：10.1167/iovs.11-7744
PURPOSE. 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.METHODS. 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.RESULTS. 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.CONCLUSIONS. 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. (In-vest Ophthalmol Vis Sci. 2012;53:1325-1331) DOI:10.1167/iovs.11-7744