Limbal Stem Cell Deficiency
Conditions
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.
Interventions
PROCEDURESurgical 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.
Sponsors
CHU de Quebec-Universite Laval
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anatomic assessment | 1 year | Global severity score (Epithelial deficit, corneal opacity, peripheral and central vascularization, integrity of the ocular surface) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected visual acuity | 1 year | Evaluation according to Snellen chart |
| Level of pain | 1 year | 11 point numerical verbal scale |
| Quality of life measurements | 1 year | Health Utilities Index Mark 3 |
Countries
Canada
Outcome results
None listed