Autologous Cultured Corneal Epithelium ( Culture d'épithélium cornéen Autologue CECA) for the Treatment of Unilateral Corneal Lesions Associated With Limbal Stem Cell Deficiency
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Limbal Stem Cell Deficiency
- Sponsor
- CHU de Quebec-Universite Laval
- Enrollment
- 54
- Locations
- 4
- Primary Endpoint
- Anatomic assessment
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
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.
Investigators
Ralph Kyrillos
Principal Investigator
CHU de Quebec-Universite Laval
Eligibility Criteria
Inclusion Criteria
- •All genders
- •LSCD in one or two eyes. A minimum of 1-3 mm2 of undamaged limbus is required for a biopsy to be taken without foreseeable adverse consequences for the donor eye
Exclusion Criteria
- •Donor eye not sufficiently healthy to allow for the harvesting of a 1-3 mm2 limbal biopsy without foreseeable consequences for the donor eye
- •Pregnancy
- •Breast-feeding
- •Incapacitated person
- •known allergy to aprotinine (Trasylol (R))
- •Hypersensibility to bovine proteins
Outcomes
Primary Outcomes
Anatomic assessment
Time Frame: 1 year
Global severity score (Epithelial deficit, corneal opacity, peripheral and central vascularization, integrity of the ocular surface)
Secondary Outcomes
- Level of pain(1 year)
- Best corrected visual acuity(1 year)
- Quality of life measurements(1 year)