Long‐term results of the phase I/II clinical trial: standardized, non‐xenogenic, cultivated limbal stem cell transplantation

Abstract

PurposeTo evaluate the long‐term success rate of transplanted non‐xenogenic, bio‐engineered, composite grafts of cultured limbal epithelial stem cells on standardized amniotic membranes in patients with limbal stem cell deficiency.MethodsWe report the extended outcome of standardized cultivated limbal stem cell transplantations of our previous phase I/II trial. Between July 2008 and May 2012, 18 patients with partial or total limbal stem cell deficiency received either autologous (n = 15) or allogenic (n = 3) stem cell explants, using a protocol free from xenogenic products and a reduced manipulation surgical technique.ResultsSix of the 18 patients were lost to follow‐up. The remaining 12 patients had a mean follow‐up of 46.6 months. Two of 10 patients experienced an evisceration, not related to the stem cell transplantation. 7 of the remaining 8 (87.5%) patients retained a persistent intact epithelium. Although we did see a significant reduction in corneal neovascularization of the corneas post transplantation, we did not see a significant improvement in visual acuity of the total cohort, although one patient gained a visual acuity from finger counting to 0.5 post limbal stem cell transplantation and post penetrating keratoplasty.ConclusionsThis standardized culture system and surgical approach is safe and effective in restoring a functional epithelial cell layer, with satisfying long‐term results. Due to the limited number of patients and the comorbidities, we did not see a significant improvement in visual acuity of the total cohort. We maintain that in selected cases this technique, followed by a penetrating keratoplasty can significantly improve visual acuity.