title: Cultured autologous oral mucosal epithelial cell sheet (CAOMECS) transplantation for the treatment of corneal limbal epithelial stem cell deficiency.
abstract: OBJECTIVE
  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.
authors: Service d'Ophtalmologie, Hôpital Edouard Herriot, 5 Place d'Arsonval, 69 437 Lyon Cedex 03, France. carole.burillon@chu-lyon.fr
authors: Carole
authors: C
authors: Burillon
authors: Laure
authors: L
authors: Huot
authors: Virginie
authors: V
authors: Justin
authors: Serge
authors: S
authors: Nataf
authors: François
authors: F
authors: Chapuis
authors: Evelyne
authors: E
authors: Decullier
authors: Odile
authors: O
authors: Damour
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017690:Cell Transplantation; D002478:Cells, Cultured; D003316:Corneal Diseases / Q000473:pathology / Q000601:surgery*; D004847:Epithelial Cells / Q000637:transplantation*; D005260:Female; D006801:Humans; D016850:Limbus Corneae / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000166:cytology*; D011446:Prospective Studies; D013234:Stem Cells / Q000473:pathology*; D014182:Transplantation, Autologous; D016896:Treatment Outcome