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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01756365
Recruitment Status : Recruiting
First Posted : December 25, 2012
Last Update Posted : February 23, 2018
Information provided by (Responsible Party):
Richard Bazin, CHU de Quebec-Universite Laval

Brief Summary:
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 or disease Intervention/treatment Phase
Limbal Stem Cell Deficiency Procedure: surgical transplantation of CECA Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2012
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: CECA Procedure: surgical transplantation of CECA

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

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

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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01756365

Centre universitaire d'Ophtalmologie CHU de Québec - HSS Recruiting
Québec, Canada, G1S 4L8
Contact: Richard Bazin, MD FRCS (C)    418-682-7573   
Principal Investigator: Richard Bazin, MD FRCS (C)         
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Principal Investigator: Richard Bazin, MD CHU de Quebec

Responsible Party: Richard Bazin, Clinical professor ophtalmology, director of the cornea service, CHU de Quebec-Universite Laval Identifier: NCT01756365     History of Changes
Other Study ID Numbers: LOEX 015
First Posted: December 25, 2012    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018