NCT01756365 Autologous Cultured Corneal Epithelium (CECA) for the Treatment of Limbal Stem Cell Deficiency
| NCT ID | NCT01756365 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CHU de Quebec-Universite Laval |
| Condition | Limbal Stem Cell Deficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2012-12 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2012-12 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Ralph Kyrillos, MD FRCS (C)
PRINCIPAL INVESTIGATOR
CHU de Quebec
Frequently Asked Questions
Who can join the NCT01756365 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, studying Limbal Stem Cell Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01756365 currently recruiting?
Yes, NCT01756365 is actively recruiting participants. Visit ClinicalTrials.gov or contact CHU de Quebec-Universite Laval to inquire about joining.
Where is the NCT01756365 trial being conducted?
This trial is being conducted at Toronto, Canada, Montreal, Canada, Montreal, Canada, Québec, Canada.
Who is sponsoring the NCT01756365 clinical trial?
NCT01756365 is sponsored by CHU de Quebec-Universite Laval. The principal investigator is Ralph Kyrillos, MD FRCS (C) at CHU de Quebec. The trial plans to enroll 54 participants.