Results of a phase I/II clinical trial: standardized, non-xenogenic, cultivated limbal stem cell transplantation

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Abstract

We describe the results of a phase I/II clinical trial for standardized, non-xenogenic, cultivation and “no touch” surgical transplantation of limbal stem cell grafts. 18 eyes of 18 patients were transplanted with either autologous (n=15) or allogenic (n=3) limbo-amnion composite grafts that were generated using a standardized culture protocol free of xenogenic culture products and transplanted using a standardized “no touch” surgical technique. In vitro cellular outgrowth and phenotype of the cultivated graft was assessed prior to transplantation. Corneal neovascularization, central corneal opacity, pain, photophobia and visual acuity were investigated pre and post transplantation. The limbal epithelial cells showed an average outgrowth of 14.2mm by day 14. The majority of the cells displayed a progenitor phenotype: p63, CK14, desmoglein, ABCG2 bright and CK3/12 dim protein expression. The transplant recipients were followed up for a mean of 22 months. 12 out of the 18 transplant recipients were graded successful, giving an overall success rate of 67%. The ocular surface photographs for pre- and post stem cell transplantation, showed a significant (p=0.007) reduction in the percentage area of corneal neovascularization.

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