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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACCE (Autologous Cultured Corneal Epithlium) graft for the treatment of corneal lesions | Experimental | Surgical transplantation of Autologous Cultured Corneal Epithelium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical transplantation of ACCE | Procedure | The culture of corneal epithelium strives to produce a reconstructed tissue with the therapeutical aim of treatment of limbal stem cell deficiency. |
| Measure | Description | Time Frame |
|---|---|---|
| Anatomic assessment | Global severity score (Epithelial deficit, corneal opacity, peripheral and central vascularization, integrity of the ocular surface) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity | Evaluation according to Snellen chart | 1 year |
| Level of pain | 11 point numerical verbal scale | 1 year |
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Inclusion Criteria:
All genders
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralph Kyrillos, MD FRCS (C) | CHU de Quebec | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network - Toronto Western Hospital | Recruiting | Toronto | Ontario | M5T 2S8 | Canada |
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| ID | Term |
|---|---|
| D000092423 | Limbal Stem Cell Deficiency |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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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.
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| Quality of life measurements | Health Utilities Index Mark 3 | 1 year |
| CIUSSS de l'Est de l'île de Montréal | Recruiting | Montreal | Quebec | H1T 2M4 | Canada |
|
| McGill University Health Centre; Centre de Médecine Innovatrice/Centre for Innovative Medicine | Recruiting | Montreal | Quebec | Canada |
|
| Centre universitaire d'Ophtalmologie CHU de Québec - HSS | Recruiting | Québec | Quebec | G1S 4L8 | Canada |
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