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.
Highlights
Corneal epithelial stem cells reside throughout the entire circumference of the corneoscleral limbal niche that includes the limbal crypts of the palisades of Vogt
We have added to the existing body of data that supports the safety and efficacy of cultivated limbal epithelial transplantation (CLET) procedures performed under good manufacturing procedures (GMP) rules for the management of ocular surface failure due to limbal stem cell deficiency (LSCD)
We showed that limbal cell expansion and culture can be successfully achieved following our protocol using GMP conditions and following European Union (EU) regulations
Summary
In LSCD, the unstable ocular surface causes recurrent corneal epithelial breakdown or nonhealing ulceration and vascularization associated with chronic inflammation These surface alterations result in pain, photophobia, decreased vision, and eventual corneal blindness [1, 4,5,6,7,8,9,10]. This syndrome engenders a high risk for corneal graft failure as the donor graft (or artificial cornea) does not have epithelial limbal cells. Amniotic membrane transplantation, useful in partial LSCD cases, is inadequate for total LSCD, requiring the addition of limbal tissue [11]
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