June 2013
Volume 54, Issue 15
Free
ARVO Annual Meeting Abstract  |   June 2013
Standardized cultivation and transplantation of limbal stem cell grafts: Results of a phase I/II clinical trial
Author Affiliations & Notes
  • Nadia Zakaria
    Ophthalmology, Antwerp University Hospital, Antwerp, Belgium
    Center for Cell Therapy and Regenerative Medicine, Antwerp University Hospital, Antwerp, Belgium
  • Tine Possemiers
    Ophthalmology, Antwerp University Hospital, Antwerp, Belgium
    Center for Cell Therapy and Regenerative Medicine, Antwerp University Hospital, Antwerp, Belgium
  • Inge Leysen
    Ophthalmology, Antwerp University Hospital, Antwerp, Belgium
  • Jos Rozema
    Ophthalmology, Antwerp University Hospital, Antwerp, Belgium
  • Carina Koppen
    Ophthalmology, Antwerp University Hospital, Antwerp, Belgium
  • Zwi Berneman
    Center for Cell Therapy and Regenerative Medicine, Antwerp University Hospital, Antwerp, Belgium
  • Marie-Jose Tassignon
    Ophthalmology, Antwerp University Hospital, Antwerp, Belgium
  • Footnotes
    Commercial Relationships Nadia Zakaria, None; Tine Possemiers, Aeon Astron Europe B.V. (F); Inge Leysen, None; Jos Rozema, None; Carina Koppen, None; Zwi Berneman, None; Marie-Jose Tassignon, None
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2013, Vol.54, 3230. doi:
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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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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract
 
Purpose
 

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.

 
Methods
 

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.

 
Results
 

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].

 
Conclusions
 

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.

 
 
Fig 1. Eyes with total limbal stem cell deficiency before (A, E) & after (C, G) limbal stem cell transplantation within the software program for corneal neovascularization (CNV) mapping: (B, F, D, H). There was a significant reduction in %area of CNV post limbal stem cell transplantation (I) (**p= 0.007), but no significant decrease in the degree of corneal opacification post stem cell transplant (J).
 
Fig 1. Eyes with total limbal stem cell deficiency before (A, E) & after (C, G) limbal stem cell transplantation within the software program for corneal neovascularization (CNV) mapping: (B, F, D, H). There was a significant reduction in %area of CNV post limbal stem cell transplantation (I) (**p= 0.007), but no significant decrease in the degree of corneal opacification post stem cell transplant (J).
 
Keywords: 482 cornea: epithelium • 550 imaging/image analysis: clinical • 479 cornea: clinical science  
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