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

NCT ID: NCT01756365

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Limbal Stem Cell Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Surgical transplantation of Autologous Cultured Corneal Epithelium

Group Type EXPERIMENTAL

Surgical transplantation of ACCE

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Quebec-Universite Laval

OTHER

Sponsor Role lead

Responsible Party

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Ralph Kyrillos

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ralph Kyrillos, MD FRCS (C)

Role: PRINCIPAL_INVESTIGATOR

CHU de Quebec

Locations

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University Health Network - Toronto Western Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

CIUSSS de l'Est de l'île de Montréal

Montreal, Quebec, Canada

Site Status RECRUITING

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

Montreal, Quebec, Canada

Site Status RECRUITING

Centre universitaire d'Ophtalmologie CHU de Québec - HSS

Québec, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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Jennifer Coleman

Role: primary

416-340-4800 ext. 5389

Dorline Sokoundjou, MSc

Role: primary

514-252-3400 ext. 7114

Natallia Barysevich, CRC/nurse

Role: primary

514-934-1934 ext. 22844

Ralph Kyrillos, MD FRCS (C)

Role: primary

418-682-7573

Lucie Germain, PhD

Role: backup

4185254444 ext. 61696

Other Identifiers

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LOEX 015

Identifier Type: -

Identifier Source: org_study_id

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