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

Study acronym: CECA
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 10, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Site contacts updated at 1 of 4 sitesv16
  2. Site contacts updated at 4 of 4 sitesv15
  3. Site details revised at 4 of 4 sitesv14
  4. Re-verified, no change to tracked fieldsv13
  5. Study sites: 3 to 4v12
Show 10 earlier versionsHide 10 earlier versions
  1. Phase: Phase 1/2 to Not applicable
    • Interventions: surgical transplantation of CECA (Procedure) to Surgical transplantation of ACCE (Procedure)
    • Secondary endpoints revised (3)
    • Site contacts updated at 2 of 3 sites
    v11
  2. Study sites: 2 to 3v10
  3. Trial status: Active, Not Recruiting to Recruitingv9 Show 7 more changesShow less
    • Enrollment target: 15 to 54
    • Primary completion date: Dec 2019 to Dec 2025
    • Primary endpoint revised
    • Study sites: 1 to 2
    • Study completion date: Jun 2020 to Dec 2027
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: 4 to 3
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v8
  5. Primary completion date: Dec 2017 to Dec 2019
    • Study completion date: Dec 2018 to Jun 2020
    • Site details revised
    v7
  6. Primary completion date: Dec 2016 to Dec 2017
    • Study completion date: Dec 2017 to Dec 2018
    v6
  7. Re-verified, no change to tracked fieldsv5
  8. Trial status: Enrolling by Invitation to Recruiting
    • Site details revised
    v4
  9. 2 versions Re-verified since Jan 30, 2014, no change to tracked fieldsv2-v3
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT01756365
Lead Sponsor CHU de Quebec-Universite Laval
Conditions
(from sponsor)		 Limbal Stem Cell Deficiency
Related terms Limbal Stem Cell Deficiency
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov