Autologous Cultured Corneal Epithelium (CECA) for the Treatment of Limbal Stem Cell Deficiency

NCT01756365 · tracked via the Priya Life Science Canada tracker

Sponsor

CHU de Quebec-Universite Laval

Phase

Not applicable

Started

2012-12

Last updated

2025-07-10

Condition(s) studied

Limbal Stem Cell Deficiency

Investigational drug(s) / intervention(s)

Surgical transplantation of ACCE

Surgical transplantation of ACCE: The culture of corneal epithelium strives to produce a reconstructed tissue with the therapeutical aim of treatment of limbal stem cell deficiency.

Study 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.

Eligibility

Sex

ALL

Min age

1 Year

Max age

—

Healthy volunteers

Inclusion Criteria: All genders * 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 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

Primary outcome measure(s)

Anatomic assessment — 1 year
Global severity score (Epithelial deficit, corneal opacity, peripheral and central vascularization, integrity of the ocular surface)

Trial sites (4)

Facility	City	Region	Status
University Health Network - Toronto Western Hospital	Toronto	Ontario	Recruiting
CIUSSS de l'Est de l'île de Montréal	Montreal	Quebec	Recruiting
McGill University Health Centre; Centre de Médecine Innovatrice/Centre for Innovative Medicine	Montreal	Quebec	Recruiting
Centre universitaire d'Ophtalmologie CHU de Québec - HSS	Québec	Quebec	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01756365 on ClinicalTrials.gov ↗ ← All trials in Canada