title: Stem Cell Therapy for Corneal Epithelium Regeneration following Good Manufacturing and Clinical Procedures.
abstract: OBJECTIVE
  To evaluate outcomes of cultivated limbal epithelial transplantation (CLET) for management of ocular surface failure due to limbal stem cell deficiency (LSCD).
  
  
  METHODS
  Prospective, noncomparative, interventional case series and extensive comparison with recent similar studies.
  
  
  METHODS
  Twenty eyes with LSCD underwent CLET (11 autologous; 9 allogeneic) and were followed up for 3 years. Etiologies were divided into 3 prognostic categories: Group 1, chemical injuries (7 eyes); Group 2, immune-based inflammation (4 eyes); and Group 3, noninflammatory diseases (9 eyes). Intervention. Autologous and allogeneic limbal epithelial cells were cultivated on amniotic membranes and transplanted. Evaluations were based on clinical parameters, survival analysis, and in vivo confocal microscopy (IVCM). European Union Tissues/Cells Directive and good manufacturing procedures were followed.
  
  
  METHODS
  Improved clinical parameters, absence of epithelial defects, and improved central corneal epithelial phenotype.
  
  
  RESULTS
  Success rate was 80% at 1-2 years and 75% at 3 years. Autografts and allografts had similar survival. Success rate was significantly lower in prognostic Group 1 (42.9%) than in Groups 2-3 (100% each). All clinical parameters improved substantially. By IVCM, 80% of cases improved in epithelial status.
  
  
  CONCLUSIONS
  CLET improved corneal epithelium quality, with subsequent improvement in symptoms, quality of life, and vision. These results confirm that CLET is a valid therapy for ocular surface failure.
authors.affiliation: Institute of Applied Ophthalmobiology (IOBA), University of Valladolid, Campus Universitario Miguel Delibes, Paseo de Belén 17, 47011 Valladolid, Spain.
authors.forename: Beatriz E
authors.initials: BE
authors.lastname: Ramírez
authors.affiliation: Institute of Molecular Biology and Genetics (IBGM), University of Valladolid, Valladolid, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Sánchez
authors.affiliation: Institute of Applied Ophthalmobiology (IOBA), University of Valladolid, Campus Universitario Miguel Delibes, Paseo de Belén 17, 47011 Valladolid, Spain ; Networking Center for Biomedical Research in Bioengineering-Biomaterials and Nanomedicine (CIBER-BBN), Carlos III National Institute of Health, Spain.
authors.forename: José M
authors.initials: JM
authors.lastname: Herreras
authors.affiliation: Institute of Applied Ophthalmobiology (IOBA), University of Valladolid, Campus Universitario Miguel Delibes, Paseo de Belén 17, 47011 Valladolid, Spain ; Networking Center for Biomedical Research in Bioengineering-Biomaterials and Nanomedicine (CIBER-BBN), Carlos III National Institute of Health, Spain.
authors.forename: Itziar
authors.initials: I
authors.lastname: Fernández
authors.affiliation: Institute of Molecular Biology and Genetics (IBGM), University of Valladolid, Valladolid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: García-Sancho
authors.affiliation: Institute of Applied Ophthalmobiology (IOBA), University of Valladolid, Campus Universitario Miguel Delibes, Paseo de Belén 17, 47011 Valladolid, Spain ; Networking Center for Biomedical Research in Bioengineering-Biomaterials and Nanomedicine (CIBER-BBN), Carlos III National Institute of Health, Spain.
authors.forename: Teresa
authors.initials: T
authors.lastname: Nieto-Miguel
authors.affiliation: Institute of Applied Ophthalmobiology (IOBA), University of Valladolid, Campus Universitario Miguel Delibes, Paseo de Belén 17, 47011 Valladolid, Spain ; Networking Center for Biomedical Research in Bioengineering-Biomaterials and Nanomedicine (CIBER-BBN), Carlos III National Institute of Health, Spain.
authors.forename: Margarita
authors.initials: M
authors.lastname: Calonge
mesh_terms: D000328:Adult; D000368:Aged; D003316:Corneal Diseases / Q000473:pathology* / Q000628:therapy*; D019573:Epithelium, Corneal / Q000473:pathology* / Q000601:surgery; D005062:European Union; D005260:Female; D006801:Humans; D016850:Limbus Corneae / Q000473:pathology* / Q000601:surgery; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D012038:Regeneration; D033581:Stem Cell Transplantation / Q000592:standards*