Actively Recruiting

Phase Not Applicable
Age: 1Year +
All Genders
NCT01756365

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

Led by CHU de Quebec-Universite Laval · Updated on 2025-07-10

54

Participants Needed

4

Research Sites

782 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 1Year +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All genders
  • Adults
  • Minors
  • Limbal stem cell deficiency (LSCD) in one or both eyes
  • A minimum of 1-3 mm2 of undamaged limbus available for biopsy without harm to the donor eye
Not Eligible

You will not qualify if you...

  • Donor eye is not healthy enough to safely allow a 1-3 mm2 limbal biopsy
  • Pregnancy
  • Breast-feeding
  • Incapacitated person
  • Known allergy to aprotinine (Trasylol)
  • Hypersensitivity to bovine proteins

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

University Health Network - Toronto Western Hospital

Toronto, Ontario, Canada, M5T 2S8

Actively Recruiting

2

CIUSSS de l'Est de l'île de Montréal

Montreal, Quebec, Canada, H1T 2M4

Actively Recruiting

3

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

Montreal, Quebec, Canada

Actively Recruiting

4

Centre universitaire d'Ophtalmologie CHU de Québec - HSS

Québec, Quebec, Canada, G1S 4L8

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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