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

Study Overview
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Brief Summary
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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.

Official Title
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Autologous Cultured Corneal Epithelium ( Culture d'épithélium cornéen Autologue CECA) for the Treatment of Unilateral Corneal Lesions Associated With Limbal Stem Cell Deficiency

Conditions
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Limbal Stem Cell Deficiency

Intervention / Treatment
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* Procedure: Surgical transplantation of ACCE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACCE (Autologous Cultured Corneal Epithlium) graft for the treatment of corneal lesions<br>Surgical transplantation of Autologous Cultured Corneal Epithelium | Procedure: Surgical transplantation of ACCE<br>* The culture of corneal epithelium strives to produce a reconstructed tissue with the therapeutical aim of treatment of limbal stem cell deficiency.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomic assessment | Global severity score (Epithelial deficit, corneal opacity, peripheral and central vascularization, integrity of the ocular surface) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity | Evaluation according to Snellen chart | 1 year | 
| Level of pain | 11 point numerical verbal scale | 1 year | 
| Quality of life measurements | Health Utilities Index Mark 3 | 1 year |