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.
Adults
Minors
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
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
Single group
Surgical transplantation of ACCE
Procedure/SurgeryThe culture of corneal epithelium strives to produce a reconstructed tissue with the therapeutical aim of treatment of limbal stem cell deficiency.
Anatomic assessment
Global severity score (Epithelial deficit, corneal opacity, peripheral and central vascularization, integrity of the ocular surface)
Best corrected visual acuity
Evaluation according to Snellen chart
Level of pain
11 point numerical verbal scale
Quality of life measurements
Health Utilities Index Mark 3
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