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BioMed Research International
Volume 2015, Article ID 408495, 19 pages
http://dx.doi.org/10.1155/2015/408495
Clinical Study

Stem Cell Therapy for Corneal Epithelium Regeneration following Good Manufacturing and Clinical Procedures

1Institute of Applied Ophthalmobiology (IOBA), University of Valladolid, Campus Universitario Miguel Delibes, Paseo de Belén 17, 47011 Valladolid, Spain
2Institute of Molecular Biology and Genetics (IBGM), University of Valladolid, Valladolid, Spain
3Networking Center for Biomedical Research in Bioengineering-Biomaterials and Nanomedicine (CIBER-BBN), Carlos III National Institute of Health, Spain

Received 26 March 2015; Accepted 17 May 2015

Academic Editor: Flavio Mantelli

Copyright © 2015 Beatriz E. Ramírez et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Objective. To evaluate outcomes of cultivated limbal epithelial transplantation (CLET) for management of ocular surface failure due to limbal stem cell deficiency (LSCD). Design. Prospective, noncomparative, interventional case series and extensive comparison with recent similar studies. Participants. 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. Main Outcome Measures. 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.