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Nadia Zakaria, Tine Possemiers, Inge Leysen, Jos Rozema, Carina Koppen, Zwi Berneman, Marie-Jose Tassignon; Standardized cultivation and transplantation of limbal stem cell grafts: Results of a phase I/II clinical trial. Invest. Ophthalmol. Vis. Sci. 2013;54(15):3230.
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To 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 limbo-amnion composite graft was assessed prior to transplantation. The clinical outcome measures investigated were: corneal neovascularization, central corneal opacity, pain, photophobia and visual acuity pre and post transplantation.
Limbal epithelial cells showed an average outgrowth of 14.2mm ±3.7mm by day 14. The majority of the cells displayed a progenitor phenotype: p63 bright, CK14, desmoglein, ABCG2 bright and CK3/12 dim protein expression. The transplant recipients were followed up for a mean of 22 months (range 4-43 months). 12 out of the 18 transplant recipients were graded successful (12 had anatomical success and 7 also attained some degree of functional success), giving an overall success rate of 67%. We did not see a significant reduction in pain, photophobia or central corneal opacity for the patient group post transplant. However, 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 [Fig.1].
We have been able to show that our standardized, xenogenic free culture system and “no touch” surgical technique has outcome measures comparable to other clinical studies. This technique has the added advantage of being free from animal contaminants such as mouse feeder layers and foetal bovine serum. Improved functional success is attained once penetrating keratoplasty is performed following successful stem cell grafting.
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