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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.
 
ClinicalTrials.gov Identifier: NCT01756365
Recruitment Status : Recruiting
First Posted : December 25, 2012
Last Update Posted : January 23, 2023
Sponsor:
Information provided by (Responsible Party):
Ralph Kyrillos, CHU de Quebec-Universite Laval

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Limbal Stem Cell Deficiency Procedure: Surgical transplantation of ACCE Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
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 2025
Estimated Study Completion Date : December 2027
Arms and Interventions
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Arm Intervention/treatment
Experimental: ACCE (Autologous Cultured Corneal Epithlium) graft for the treatment of corneal lesions
Surgical transplantation of Autologous Cultured Corneal Epithelium
 Procedure: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Anatomic assessment [ Time Frame: 1 year ]
    Global severity score (Epithelial deficit, corneal opacity, peripheral and central vascularization, integrity of the ocular surface)


Secondary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: 1 year ]
    Evaluation according to Snellen chart

  2. Level of pain [ Time Frame: 1 year ]
    11 point numerical verbal scale

  3. Quality of life measurements [ Time Frame: 1 year ]
    Health Utilities Index Mark 3


Eligibility Criteria
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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01756365


Locations
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Canada, Ontario
University Health Network - Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Jennifer Coleman    4163404800 ext 5389      
Principal Investigator: Allan Slomovic, MD,FRCSC         
Canada, Quebec
CIUSSS de l'Est de l'île de Montréal Recruiting
Montréal, Quebec, Canada, H1T 2M4
Contact: Dorline Sokoundjou, MSc    514-252-3400 ext 7114    bfv2.hmr@ssss.gouv.qc.ca   
Principal Investigator: Isabelle Brunette, MD         
Canada
Centre universitaire d'Ophtalmologie CHU de Québec - HSS Recruiting
Québec, Canada, G1S 4L8
Contact: Ralph Kyrillos, MD FRCS (C)    418-682-7573    ralph.kyrillos.1@ulaval.ca   
Contact: Lucie Germain, PhD    4185254444 ext 61696    lucie.germain@fmed.ulaval.ca   
Principal Investigator: Ralph Kyrillos, MD FRCS (C)         
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Investigators
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Principal Investigator: Ralph Kyrillos, MD FRCS (C) CHU de Quebec
More Information
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Responsible Party: Ralph Kyrillos, Clinical ophtalmology professor, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT01756365    
Other Study ID Numbers: LOEX 015
First Posted: December 25, 2012    Key Record Dates
Last Update Posted: January 23, 2023
Last Verified: January 2023