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.