RecruitingNot Applicable

Autologous Cultured Corneal Epithelium (CECA) for the Treatment of Limbal Stem Cell Deficiency

Canada54 participantsStarted 2012-12

Plain-language 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.

Who can participate

Age range1 Year

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Anatomic assessment

Timeframe: 1 year

Trial details

NCT IDNCT01756365

SponsorCHU de Quebec-Universite Laval

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

View on ClinicalTrials.gov More Limbal Stem Cell Deficiency trials