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

Laval University

Status: Enrolling

Conditions: Limbal Stem Cell Deficiency

Treatments: Procedure: Surgical transplantation of ACCE

Study type: Interventional

Funder types: Other

Identifiers

NCT01756365

LOEX 015

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

ACCE (Autologous Cultured Corneal Epithlium) graft for the treatment of corneal lesions

Experimental group

Description:

Surgical transplantation of Autologous Cultured Corneal Epithelium

Treatment:

Procedure: Surgical transplantation of ACCE