The study " Autologous cultured corneal epithelium (CECA) for the treatment of corneal lesions associated with limbal stem cell deficiency" is the first clinical trial of this product manufactured at the LOEX laboratory. The culture of corneal epithelium strives to produce a reconstructed tissue with the therapeutical aim of treatment of limbal stem cell deficiency. The study is a phase I/phase II study with the goal to evaluate safety and efficacy of the CECA graft for the treatment of human patients suffering from limbal stem cell deficiency. The trial is open to all genders. The inclusion of 5 minors is planned.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
The culture of corneal epithelium strives to produce a reconstructed tissue with the therapeutical aim of treatment of limbal stem cell deficiency.
University Health Network - Toronto Western Hospital
Toronto, Ontario, Canada
RECRUITINGCIUSSS de l'Est de l'île de Montréal
Montreal, Quebec, Canada
RECRUITINGMcGill University Health Centre; Centre de Médecine Innovatrice/Centre for Innovative Medicine
Montreal, Quebec, Canada
RECRUITINGCentre universitaire d'Ophtalmologie CHU de Québec - HSS
Québec, Quebec, Canada
RECRUITINGAnatomic assessment
Global severity score (Epithelial deficit, corneal opacity, peripheral and central vascularization, integrity of the ocular surface)
Time frame: 1 year
Best corrected visual acuity
Evaluation according to Snellen chart
Time frame: 1 year
Level of pain
11 point numerical verbal scale
Time frame: 1 year
Quality of life measurements
Health Utilities Index Mark 3
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.