Treatment of LSCD using cultured limbal epithelium expanded ALSC. V3.0

• Research type

  Research Study

• Full title

  To evaluate the safety and effectiveness of human ex vivo expanded autologous limbal stem cells for the treatment of unilateral total limbal stem cell deficiency

• IRAS ID

  64730

• Contact name

  Francisco C Figueiredo

• Eudract number

  2011-000608-16

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The cornea is the clear window at the front of the eye and its clarity is vital for light transmission to the back of the eye for visual perception. Transparency of the cornea depends upon the integrity of its outermost layer called the epithelium, which is constantly regenerated throughout life by a population of stem cells found at the edge of the cornea in an area called the limbus, the so called limbal stem cells (LSC). If LSC becomes deficient as a result of injury or disease, this epithelium will breakdown leading to severe pain and blindness. This condition is often difficult to treat, however, the management of limbal stem cell deficiency (LSCD) has benefited from major breakthroughs in recent years. LSC from the patient??s own (one eye disease) or a relative healthy eye or from a cadaveric eye can grow in the laboratory and then transplanted to the diseased eye. This technique however uses animal products to help grow the cells with a great risk of diseases transmission. In addition, the safety and effectiveness of this treatment is rather difficult to establish due to the small number of cases reported. Transplantation of cultured limbal epithelium can therefore not be recognized, enabling NHS funding, until its effectiveness and safety is determined by a clinical trial. Such a trial forms the main objective of this project. We have therefore developed an ??animal product free?? technique for growing the cells in the laboratory in an ultra-clean environment and successfully transplanted 9 patients with LSCD in one eye by taking LSC from their healthy other eye. Despite of our success, this number of patients is not significant to draw proper conclusions. This project aims therefore to evaluate the safety and efficacy of our methods by treating 24 more patients with total unilateral LSCD.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  11/NE/0236

• Date of REC Opinion

  16 Aug 2011

• REC opinion

  Favourable Opinion