Autologous Cultured Corneal Epithelium (CECA) for the Treatment of Limbal Stem Cell Deficiency
NCT ID: NCT01756365
Last Updated: 2025-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
54 participants
INTERVENTIONAL
2012-12-31
2027-12-31
Brief Summary
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The trial is open to all genders. The inclusion of 5 minors is planned.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ACCE (Autologous Cultured Corneal Epithlium) graft for the treatment of corneal lesions
Surgical transplantation of Autologous Cultured Corneal Epithelium
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy
* Breast-feeding
* Incapacitated person
* known allergy to aprotinine (Trasylol (R))
* Hypersensibility to bovine proteins
1 Year
ALL
No
Sponsors
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CHU de Quebec-Universite Laval
OTHER
Responsible Party
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Ralph Kyrillos
Principal Investigator
Principal Investigators
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Ralph Kyrillos, MD FRCS (C)
Role: PRINCIPAL_INVESTIGATOR
CHU de Quebec
Locations
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University Health Network - Toronto Western Hospital
Toronto, Ontario, Canada
CIUSSS de l'Est de l'île de Montréal
Montreal, Quebec, Canada
McGill University Health Centre; Centre de Médecine Innovatrice/Centre for Innovative Medicine
Montreal, Quebec, Canada
Centre universitaire d'Ophtalmologie CHU de Québec - HSS
Québec, Quebec, Canada
Countries
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Facility Contacts
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Jennifer Coleman
Role: primary
Other Identifiers
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LOEX 015
Identifier Type: -
Identifier Source: org_study_id
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