Autologous Cultured Corneal Epithelium (CECA) for the Treatment of Limbal Stem Cell Deficiency (CECA)
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ClinicalTrials.gov Identifier: NCT01756365 |
Recruitment Status :
Recruiting
First Posted : December 25, 2012
Last Update Posted : January 23, 2023
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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 |
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Limbal Stem Cell Deficiency | Procedure: Surgical transplantation of ACCE | Not Applicable |
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 |
Arm | Intervention/treatment |
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Experimental: ACCE (Autologous Cultured Corneal Epithlium) graft for the treatment of corneal lesions
Surgical transplantation of Autologous Cultured Corneal Epithelium
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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. |
- Anatomic assessment [ Time Frame: 1 year ]Global severity score (Epithelial deficit, corneal opacity, peripheral and central vascularization, integrity of the ocular surface)
- Best corrected visual acuity [ Time Frame: 1 year ]Evaluation according to Snellen chart
- Level of pain [ Time Frame: 1 year ]11 point numerical verbal scale
- Quality of life measurements [ Time Frame: 1 year ]Health Utilities Index Mark 3

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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 |
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

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
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) |
Principal Investigator: | Ralph Kyrillos, MD FRCS (C) | CHU de Quebec |
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 |