Regeneration of the anterior cornea through a standardized, non-xenogenic, cultivated limbal stem cell transplantation: Results of a phase II clinical trial.

Abstract

Purpose : Cultivated limbal stem cell transplantation (CLET) is a cell-based surgical treatment for the treatment of limbal stem cell deficiency (LSCD). We report the results of a phase II multicenter trial, in which non-xenogenic, bioengineered, composite grafts of cultured limbal epithelial cells on standardized amniotic membranes are transplanted onto stem cell deficient eyes.

Methods : Between April 2015 and October 2017, 19 patients with total LSCD received either autologous (n=13) or allogenic (n=6) stem cell transplants, using a protocol free from xenogenic products and a reduced manipulation surgical technique.

Results : A total of 24 transplantations were performed on 19 eyes. Two patients were excluded because of loss to follow-up or unrelated side effects. The mean follow-up period of the remaining 17 patients was 14 months (range 1–30 months). Five patients (29,4%) had combination surgery with CLET together with penetrating keratoplasty (PK) and another five patients (29,4%) received a PK after a mean of 45 weeks (range 3-85weeks).
A total anatomical success was seen in 11 (64,7%) patients whereas 1 (5,8%) patient was graded as partial success. There was a significant reduction in pain, photophobia and best-corrected visual acuity (p<0,05). Five patients (29,4%) received a second transplantation because of epithelium closure problems and/or revascularization.

Conclusions : Transplantation of ex vivo cultivated limbal stem cells through this standardized culture protocol and surgical approach can offer corneal rehabilitation in both unilateral and bilateral stem cell deficient eyes, with successful functional outcomes. However, despite the safety of this technique, the treatment of LSCD remains challenging because of the heterogeneity of the population and associated comorbidities. If revascularization occurs or epithelial defects recur, a second transplantation can be offered.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

 

Overview cultivated limbal stem cell procedure