Skip to main content
OpenTrials
Recruiting

NCT Number: NCT01756365

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Limbal Stem Cell Deficiency Corneal Diseases Eye Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network - Toronto Western Hospital, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical transplantation of ACCE

Procedure

The culture of corneal epithelium strives to produce a reconstructed tissue with the therapeutical aim of treatment of limbal stem cell deficiency.

Primary outcomes

  1. Anatomic assessment

    Time frame: 1 year

    Global severity score (Epithelial deficit, corneal opacity, peripheral and central vascularization, integrity of the ocular surface)

Secondary outcomes

  1. Best corrected visual acuity

    Time frame: 1 year

    Evaluation according to Snellen chart

  2. Level of pain

    Time frame: 1 year

    11 point numerical verbal scale

  3. Quality of life measurements

    Time frame: 1 year

    Health Utilities Index Mark 3

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Official study title

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

Acronym: CECA

Important dates

Study start
2012
Primary completion
2025
Study completion
2027
First posted
Dec 25, 2012
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.