Using cultured corneal cells to treat limbal stem cell deficiency
Autologous Cultured Corneal Epithelium ( Culture d'épithélium cornéen Autologue CECA) for the Treatment of Unilateral Corneal Lesions Associated With Limbal Stem Cell Deficiency
This study is testing if transplanting specially grown corneal cells can help people with limbal stem cell deficiency improve their eye health and vision.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | CHU de Quebec-Universite Laval Academic / other |
| Locations | 4 sites (Toronto, Ontario and 3 other locations) |
| Trial ID | NCT01756365 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of autologous cultured corneal epithelium (CECA) grafts for patients suffering from limbal stem cell deficiency. The approach involves surgically transplanting cultured corneal cells to reconstruct damaged tissue in the eye. The study aims to assess how well this treatment can restore corneal health and improve vision in affected individuals. It includes participants of all genders, with a planned inclusion of minors, and requires a small biopsy from a healthy part of the eye for the procedure.
Who should consider this trial
Good fit: Ideal candidates are individuals with limbal stem cell deficiency in one or both eyes who have sufficient healthy limbal tissue for biopsy.
Not a fit: Patients with an unhealthy donor eye that cannot safely provide a limbal biopsy or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve vision and quality of life for patients with limbal stem cell deficiency.
How similar studies have performed: While this approach is novel, similar studies involving tissue engineering for ocular conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario and 3 other locations
- University Health Network - Toronto Western Hospital — Toronto, Ontario, Canada (Recruiting)
- CIUSSS de l'Est de l'île de Montréal — Montreal, Quebec, Canada (Recruiting)
- McGill University Health Centre; Centre de Médecine Innovatrice/Centre for Innovative Medicine — Montreal, Quebec, Canada (Recruiting)
- Centre universitaire d'Ophtalmologie CHU de Québec - HSS — Québec, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Ralph Kyrillos, MD FRCS (C) — CHU de Quebec
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.