Actively Recruiting
Autologous Cultured Corneal Epithelium for Treating Unilateral Corneal Lesions Associated with Limbal Stem Cell Deficiency
Led by CHU de Quebec-Universite Laval · Updated on 2025-07-10
54
Participants Needed
4
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Autologous Cultured Corneal Epithelium (CECA) for treating corneal lesions caused by limbal stem cell deficiency, a condition affecting the eye's surface. This is the first clinical trial using a CECA product made at the LOEX laboratory. The study is a phase I/II trial designed to assess the safety and effectiveness of this graft in patients suffering from this condition. The trial includes participants of all genders, with plans to include five minors. The treatment involves surgical transplantation of the CECA graft, which is cultured corneal epithelium aimed at repairing damaged tissue caused by limbal stem cell deficiency. This procedure is the main intervention and is designed to restore the corneal surface by transplanting the reconstructed tissue to the affected eye. The trial does not involve additional treatment groups or placebo comparisons. Participants will be monitored for one year after the transplantation, with evaluations including anatomic assessments of the cornea, measurements of best corrected visual acuity, pain levels, and quality of life. These assessments help researchers understand the graft's impact on eye health and patient well-being. The study is sponsored by CHU de Quebec-Universite Laval and began in December 2012, with an estimated end date in December 2027.
CONDITIONS
Brief Title
Autologous Cultured Corneal Epithelium (CECA) for the Treatment of Limbal Stem Cell Deficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All genders
- Adults and minors aged 1 year and older
- Diagnosis of limbal stem cell deficiency in one or both eyes
- Donor eye must have at least 1-3 mm2 of undamaged limbus suitable for biopsy without expected harm
You will not qualify if you...
- Donor eye not healthy enough for harvesting a 1-3 mm2 limbal biopsy without harm
- Pregnancy
- Breast-feeding
- Incapacitated person
- Known allergy to aprotinine (Trasylol (R))
- Hypersensitivity to bovine proteins
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo surgical transplantation of Autologous Cultured Corneal Epithelium to treat corneal lesions associated with limbal stem cell deficiency, followed by immediate post-operative care.
1 surgical visit and several immediate post-operative visits
Duration - 1 year
Participants are monitored for anatomical outcomes, visual acuity, pain levels, and quality of life for up to 1 year after surgery.
Regular follow-up visits over 1 year
Trial Site Locations
Total: 4 locations
1
University Health Network - Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
2
CIUSSS de l'Est de l'île de Montréal
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
3
McGill University Health Centre; Centre de Médecine Innovatrice/Centre for Innovative Medicine
Montreal, Quebec, Canada
Actively Recruiting
4
Centre universitaire d'Ophtalmologie CHU de Québec - HSS
Québec, Quebec, Canada, G1S 4L8
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here