Clinical outcomes of xeno-free allogeneic cultivated limbal epithelial transplantation for bilateral limbal stem cell deficiency

Purpose To report the clinical outcomes of allogeneic cell-based therapy for bilateral corneal blindness due to limbal stem cell deficiency (LSCD). Methods This retrospective study included 28 eyes of 21 patients, at least 8 years of age, with bilateral and total LSCD, treated between 2001 and 2010. A limbal biopsy was obtained from the eye of an adult living related donor. The limbal epithelial cells were cultivated in the laboratory using a xeno-free explant culture technique and transplanted onto the recipient eye after 10-14 days. All transplant recipients received topical and systemic immunosuppressants. Results At a mean follow-up of 4.8 +/- 2.8 years, 20 (71.4%) eyes maintained a completely epithelised, avascular and stable corneal surface, and among them 13 (46.4%) eyes subsequently underwent a penetrating keratoplasty (PK). The Kaplan-Meier survival rate of the PK allograft was 76.9 +/- 11.7% at 1 year with a median survival of 3.3 years. Visual acuity improved to 20/60 or better in 19 (67.8%) eyes. No donor or recipient eyes developed serious ocular complications. Conclusions Allogeneic cultivated limbal epithelial transplantation, followed by PK when needed, can successfully restore the ocular surface and improve vision in patients with corneal blindness due to bilateral LSCD.