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

Limbal Stem Cell Deficiency

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    1 and up

Participation Criteria

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 Location

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

Contact Study Team

Backup Contact

Ralph Kyrillos, MD FRCS (C)

Primary Contact

Ralph Kyrillos, MD FRCS (C)

[email protected]
418-682-7573
Backup Contact

Lucie Germain, PhD

[email protected]
4185254444
McGill University Health Centre; Centre de Médecine Innovatrice/Centre for Innovative Medicine
McGill University Health Centre; Centre de Médecine Innovatrice/Centre for Innovative Medicine
Montréal, Quebec
Canada

Contact Study Team

Backup Contact

Guillermo Rocha, MD, FRCSC

Primary Contact

Natallia Barysevich, CRC/nurse

[email protected]
514-934-1934
University Health Network - Toronto Western Hospital
University Health Network - Toronto Western Hospital
Toronto, Ontario
Canada

Contact Study Team

Backup Contact

Allan Slomovic, MD,FRCSC

Primary Contact

Jennifer Coleman

4163404800
CIUSSS de l'Est de l'île de Montréal
CIUSSS de l'Est de l'île de Montréal
Montréal, Quebec
Canada

Contact Study Team

Primary Contact

Dorline Sokoundjou, MSc

[email protected]
514-252-3400
Backup Contact

Isabelle Brunette, MD

Study Sponsored By
CHU de Quebec-Universite Laval
Participants Required
More Information
Study ID: NCT01756365