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Translational and Clinical Research
Successful Clinical Implementation of Corneal Epithelial Stem Cell Therapy for Treatment of Unilateral Limbal Stem Cell Deficiency†
Article first published online: 10 DEC 2009
DOI: 10.1002/stem.276
Copyright © 2009 AlphaMed Press
Additional Information
How to Cite
Kolli, S., Ahmad, S., Lako, M. and Figueiredo, F. (2010), Successful Clinical Implementation of Corneal Epithelial Stem Cell Therapy for Treatment of Unilateral Limbal Stem Cell Deficiency. STEM CELLS, 28: 597–610. doi: 10.1002/stem.276
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Author contributions: S.A. and S.K.: Conception and design of the study, collection and assembly of data, data analysis and interpretation, manuscript writing and clinical work; S.A. and S.K. contributed equally to this work; M.L.: Conception and design of the study, fund raising, data analysis and interpretation, and manuscript writing; F.C.F.: Conception and design of the study, fund raising, collection and assembly of data, data analysis and interpretation, manuscript writing, and clinical work.
Disclosure of potential conflicts of interest is found at the end of this article.
First published online in STEM CELLSEXPRESS December 10, 2009.
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Telephone: 00 44 191 241 8688; Fax: 00 44 191 241 8,666
Publication History
- Issue published online: 24 MAR 2010
- Article first published online: 10 DEC 2009
- Accepted manuscript online: 10 DEC 2009 12:00AM EST
- Manuscript Accepted: 1 DEC 2009
- Manuscript Received: 24 SEP 2009
Funded by
- Newcastle Healthcare Charity
- Life Knowledge Park
- One North East Developmental Agency
- U.K. NIHR Biomedical Research Centre for Ageing and Age-related Disease
- Newcastle upon Tyne NHS Hospitals Trust
Keywords:
- Ex vivo expansion;
- Corneal epithelial stem cells;
- Limbal stem cells;
- Limbal stem cell deficiency
Abstract
The corneal epithelium is maintained by a population of stem cells known as limbal stem cells (LSCs) due to their location in the basal layer of the outer border of the cornea known as the limbus. Treatment of limbal stem cell deficiency (LSCD) has been achieved with transplantation of ex vivo expanded LSCs taken from a small biopsy of limbus. This is a relatively new technique, and as such, specific national or international guidance has yet to be established. Because of the lack of such specific guidance, our group has sought to minimize any risk to the patient by adopting certain modifications to the research methodologies in use at present. These include the replacement of all non-human animal products from the culture system and the production of all reagents and cultures under Good Manufacturing Practice conditions. In addition, for the first time, a strictly defined uniform group of patients with total unilateral LSCD and no other significant ocular conditions has been used to allow the success or failure of treating LSCD to be attributable directly to the proposed stem cell therapy. A prospectively designed study with strict inclusion and exclusion criteria was used to enroll patients from our database of patients with unilateral LSCD. Eight eyes of eight consecutive patients with unilateral total LSCD treated with ex vivo expanded autologous LSC transplant on human amniotic membrane (HAM) with a mean follow-up of 19 (RANGE) months were included in the study. Postoperatively, satisfactory ocular surface reconstruction with a stable corneal epithelium was obtained in all eyes (100%). At last examination, best corrected visual acuity improved in five eyes and remained unchanged in three eyes. Vision impairment and pain scores improved in all patients (p < .05). This study demonstrates that transplantation of autologous limbal epithelial stem cells cultured on HAM without the use of non-human animal cells or products is a safe and effective method of reconstructing the corneal surface and restoring useful vision in patients with unilateral total LSCD. STEM CELLS 2010;28:597–610

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