Autologous Cultured Corneal Epithelium (CECA) for the Treatment of Limbal Stem Cell Deficiency
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgical transplantation of ACCE.
- Who it may be relevant to
- Registry conditions: Limbal Stem Cell Deficiency. Basic parameters: from 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Autologous Cultured Corneal Epithelium ( Culture d'épithélium cornéen Autologue CECA) for the Treatment of Unilateral Corneal Lesions Associated With Limbal Stem Cell Deficiency
Overview
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
- Procedure Surgical 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.
Primary outcome measures
- Anatomic assessment [Time frame: 1 year]
Secondary outcome measures (3)
- Best corrected visual acuity [Time frame: 1 year]
- Level of pain [Time frame: 1 year]
- Quality of life measurements [Time frame: 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 4 centers
- University Health Network - Toronto Western Hospital — Toronto
- CIUSSS de l'Est de l'île de Montréal — Montreal
- McGill University Health Centre; Centre de Médecine Innovatrice/Centre for Innovative Medi — Montreal
- Centre universitaire d'Ophtalmologie CHU de Québec - HSS — Québec
Identifiers
NCT: NCT01756365 · LOEX 015