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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Centre Hospitalier Universitaire de Québec, CHU de Québec
Sponsor:
Information provided by (Responsible Party):
Richard Bazin, Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT01756365
First received: December 20, 2012
Last updated: February 9, 2016
Last verified: February 2016
  Purpose
The study " Autologous cultured corneal epithelium (CECA) for the treatment of unilateral 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 unilateral limbal stem cell deficiency (only one eye is affected by the 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.

Condition Intervention Phase
Limbal Stem Cell Deficiency
Procedure: surgical transplantation of CECA
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Cultured Corneal Epithelium ( Culture d'épithélium cornéen Autologue CECA) for the Treatment of Unilateral Corneal Lesions Associated With Limbal Stem Cell Deficiency

Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 1 year ]
    Evaluation according to the Snellen scale


Secondary Outcome Measures:
  • epithelial deficit [ Time Frame: 1 year ]
    Slit lamp examination: coloration with Fluorescein

  • Opacity / transparency of the cornea [ Time Frame: 1 year ]
    Slit lamp examination

  • peripheral and central vascularization [ Time Frame: 1 year ]
    Slit lamp examination

  • Integrity of the surface of the epithelium [ Time Frame: 1 year ]
    Slit lamp examination


Estimated Enrollment: 15
Study Start Date: December 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CECA Procedure: surgical transplantation of CECA

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients with limbal stem cell deficiency

Exclusion Criteria:

  • Bilateral limbal stem cell deficiency
  • Unilateral limbal stem cell deficiency with more than 50% of damage to the contralateral eye
  • Pregnancy
  • Breast-feeding
  • Minors
  • known allergy to aprotinine (Trasylol (R))
  • Hypersensibility to bovine proteins
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756365

Locations
Canada, Quebec
Centre universitaire d'Ophtalmologie CHU de Québec - HSS Recruiting
Québec, Quebec, Canada, G1S 4L8
Contact: Richard Bazin, MD FRCS (C)    418-682-7573    secretariat@loex.qc.ca   
Principal Investigator: Richard Bazin, MD FRCS (C)         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Québec, CHU de Québec
Investigators
Principal Investigator: Richard Bazin, MD CHU de Quebec
  More Information

Responsible Party: Richard Bazin, Clinical professor ophtalmology, director of the cornea service, Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier: NCT01756365     History of Changes
Other Study ID Numbers: LOEX 015 
Study First Received: December 20, 2012
Last Updated: February 9, 2016
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on July 28, 2016