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

NCT01756365 | Recruiting

• 1 other identifier: LOEX 015
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 4

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.

Conditions

Limbal Stem Cell Deficiency

Outcome Measures

Primary Outcomes (1)

• Anatomic assessment

  Global severity score (Epithelial deficit, corneal opacity, peripheral and central vascularization, integrity of the ocular surface)

  1 year

Secondary Outcomes (3)

• Best corrected visual acuity

  1 year

• Level of pain

  1 year

• Quality of life measurements

  1 year

Study Arms (1)

ACCE (Autologous Cultured Corneal Epithlium) graft for the treatment of corneal lesions

EXPERIMENTAL

Surgical transplantation of Autologous Cultured Corneal Epithelium

Procedure: Surgical transplantation of ACCE

Interventions

Surgical transplantation of ACCE PROCEDURE

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

ACCE (Autologous Cultured Corneal Epithlium) graft for the treatment of corneal lesions

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (4)

University Health Network - Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

CIUSSS de l'Est de l'île de Montréal

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

McGill University Health Centre; Centre de Médecine Innovatrice/Centre for Innovative Medicine

Montreal, Quebec, Canada

RECRUITING

Centre universitaire d'Ophtalmologie CHU de Québec - HSS

Québec, Quebec, G1S 4L8, Canada

RECRUITING

MeSH Terms

Conditions

Limbal Stem Cell Deficiency

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Ralph Kyrillos, MD FRCS (C)

  CHU de Quebec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 25, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

CA (4)