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Title: The safety and efficacy of ex vivo expanded autologous limbal stem cells for the treatment of unilateral total limbal stem cell deficiency
Author: Baylis, Oliver Jack
ISNI:       0000 0004 7233 9396
Awarding Body: University of Newcastle upon Tyne
Current Institution: University of Newcastle upon Tyne
Date of Award: 2014
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The cornea is the clear window at the front of the eye, which allows light to focus onto the retina. The outer surface is covered in epithelial cells that are continually replaced by a population of stem cells located at the edge of the cornea termed the limbal stem cells. Limbal stem cell deficiency (LSCD) results in epithelial failure and conjunctival overgrowth, resulting in a painful, blinding disease. This condition can be treated by the transplantation of ex vivo expanded limbal stem cells from a donor eye in a technique originally described by Pellegrini et al. in 1997. Previously, a protocol that includes all animal-free products has been successfully used to treat nine patients in a phase I study. The main aim of this thesis is to conduct a phase II clinical study to evaluate the safety and efficacy of ex vivo expanded autologous limbal stem cell transplantation in patients with unilateral limbal stem cell deficiency, using a range of objective outcomes. This study has met all regulatory requirements regarding good clinical practice and good manufacturing practices for stem cell culture. Data is presented for the first nine treated patients with six month follow-up, including restoration of the corneal epithelium by clinical evaluation and in vivo confocal microscopy, and by cytological confirmation using cytokeratin markers. There were also improvements in patient-reported outcomes. There were no serious adverse events and no donor eye complications following biopsy. The use of optical coherence tomography to determine corneal opacity as an outcome measure and a potential tool to predict visual outcome following therapy has been developed. In addition, the demonstration of ocular surface inflammation by tear cytokine analysis has been undertaken for the first time in LSCD; this minimally invasive technique has potential as an assessment and outcome measure that could assist clinical management.
Supervisor: Figueiredo, Francisco ; Lako, Majlinda ; Berry, Monica Sponsor: Not available
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID:  DOI: Not available