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

Not Applicable

Recruiting

• Conditions: Limbal Stem Cell Deficiency
• Interventions: Procedure: Surgical transplantation of ACCE

• Registration Number: NCT01756365
• Lead Sponsor: CHU de Quebec-Universite Laval

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2012-12-20
• Study First Posted: 2012-12-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ACCE (Autologous Cultured Corneal Epithlium) graft for the treatment of corneal lesions	Surgical transplantation of ACCE	Surgical transplantation of Autologous Cultured Corneal Epithelium

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Level of pain	1 year	11 point numerical verbal scale
Best corrected visual acuity	1 year	Evaluation according to Snellen chart
Quality of life measurements	1 year	Health Utilities Index Mark 3

Trial Locations

Locations (4)

University Health Network - Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada

CIUSSS de l'Est de l'île de Montréal; 🇨🇦 Montréal, Quebec, Canada

McGill University Health Centre; Centre de Médecine Innovatrice/Centre for Innovative Medicine; 🇨🇦 Montréal, Quebec, Canada

Centre universitaire d'Ophtalmologie CHU de Québec - HSS; 🇨🇦 Québec, Quebec, Canada