title: Clinical outcomes of xeno-free expansion and transplantation of autologous ocular surface epithelial stem cells via contact lens delivery: a prospective case series.
abstract: BACKGROUND
  Depletion of limbal stem cells leads to a debilitating condition known as limbal stem cell deficiency, characterised by impaired corneal wound healing and poor vision. The aim of this study was to determine whether delivering progenitor cells on a contact lens is a viable and effective alternative to current transplantation techniques, which are complicated by biological and xenogeneic materials.
  
  
  METHODS
  Sixteen eyes of 16 patients who had total (n=14) and partial (n=2) limbal stem cell deficiency (chemical burns, five eyes; iatrogenic causes, four eyes; aniridia, three eyes; trachoma-induced, two eyes; contact lens over-wear, one eye; and cicatrising conjunctivitis, one eye) and who had failed prior therapy were recruited prospectively into the study. Autologous limbal (n=7) or conjunctival epithelial (n=9) biopsies were harvested from patients and placed on the concave surface of silicone hydrogel contact lenses. Cells were expanded in culture with autologous serum and transplanted onto the ocular surface.
  
  
  RESULTS
  Restoration of a transparent avascular and clinically stable corneal epithelium was attained in 10 of 16 eyes (63%) at a median follow-up time of 2.5 years (range of 0.8 to 5.8 years). Although minor complications occurred in two eyes of two patients because of contact lens insertion or removal, these were not associated with long-term sequelae.
  
  
  CONCLUSIONS
  This is the first and largest study to evaluate the mid-term outcomes of autologous limbal/conjunctival stem cell transplantation via a US Food and Drug Administration-approved contact lens, demonstrating that delivery of ocular progenitor cells via this procedure offers a viable, effective, and xeno-free alternative to current transplantation methodologies.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry ACTRN012607000211460. Registered 17 April 2007.
authors.affiliation: School of Medical Sciences, University of New South Wales, High Street, Kensington, Sydney, 2052, Australia. samantha.bobba@gmail.com.|Faculty of Medicine, University of New South Wales, High Street, Kensington, Sydney, 2052, Australia. samantha.bobba@gmail.com.
authors.forename: Samantha
authors.initials: S
authors.lastname: Bobba
authors.affiliation: School of Medical Sciences, University of New South Wales, High Street, Kensington, Sydney, 2052, Australia. sharronchow@hotmail.com.
authors.forename: Sharron
authors.initials: S
authors.lastname: Chow
authors.affiliation: Save Sight Institute, University of Sydney, 8 Macquarie Street, Sydney, 2000, Australia. stephanie.watson@sydney.edu.au.|Sydney Eye Hospital, 8 Macquarie Street, Sydney, 2000, Australia. stephanie.watson@sydney.edu.au.|Faculty of Medicine, University of New South Wales, High Street, Kensington, Sydney, 2052, Australia. stephanie.watson@sydney.edu.au.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Watson
authors.affiliation: School of Medical Sciences, University of New South Wales, High Street, Kensington, Sydney, 2052, Australia. n.digirolamo@unsw.edu.au.
authors.forename: Nick
authors.initials: N
authors.lastname: Di Girolamo
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001315:Australia; D002478:Cells, Cultured; D003261:Contact Lenses; D003316:Corneal Diseases / Q000473:pathology / Q000628:therapy*; D004847:Epithelial Cells / Q000637:transplantation*; D019573:Epithelium, Corneal / Q000166:cytology / Q000473:pathology / Q000601:surgery*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D033581:Stem Cell Transplantation; D013234:Stem Cells / Q000502:physiology; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014945:Wound Healing / Q000502:physiology