Cultured Autologous Oral Mucosal Epithelial Cell Sheet (CAOMECS) Transplantation for the Treatment of Corneal Limbal Epithelial Stem Cell Deficiency

摘要: Purpose Total bilateral corneal limbal epithelial stem cell deficiency (LSCD) cannot be treated with the surgical transplantation of autologous limbus or cultured epithelium. Transplantation allogenic epithelium is possible but requires immunosuppressive treatments. Cultured oral mucosal sheet (CAOMECS) a transparent, resistant, viable, and rapidly bioadhesive sheet, UpCell-Insert technology (CellSeed, Inc., Tokyo, Japan), which allows for grafting onto patient's stroma without suturing. It has therefore been proposed as an alternative treatment LSCD. Methods The objectives were to assess safety efficacy CAOMECS, using prospective Gehan's design. Safety was measured in terms ocular adverse events during study period, composite criterion based on defect, punctate keratopathy, conjunctival cornea, number vascular pediculi, vessel activity. Results CAOMECS found safe effective. In total, 26 eyes 25 patients received graft. Two experienced serious classified not product related. Twenty-five included analysis, one patient lost follow-up. effective 16 at 360 days after grafting. Of 23 who completed follow-up days, 22 had no ulcers, 19 showed decrease severity keratopathy. Conclusions well-tolerated tissue-engineered product. These results suggest its reconstructing surface total