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Cultivated Limbal Epithelial Transplantation (CLET) for Limbal Stem Cell Deficiency (LSCD)

Study acronym: CLET-4-LSCD
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 16, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Start date: Nov 2024 to Nov 2025v4
  2. Notable Primary and study completion dates: Dec 31, 2022 to Dec 31, 2025
    • Start date: Apr 1, 2022 to Nov 2024
    v3
  3. Notable Primary completion date: Dec 31, 2019 to Dec 31, 2022
    • Start date: Apr 1, 2019 to Apr 1, 2022
    • Study completion date: Dec 31, 2020 to Dec 31, 2022
    v2
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
CLET is a published treatment for the management of corneal failure due to extensive LSCD. Due to our previous studies on this novel treatment, the regulatory agency of Spain "Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)" authorized our institution (IOBA-University of Valladolid) to perform this kind of therapy (CLET) in a case-by-case base following the Special Situation Medicines Policy Procedure in Spain. Upon approval of the permanent authorization patients will be included as specified by AEMPS.The objective of this study is to perform a protocolized treatment and follow up so that results can be reported to the scientific community.
Trial Details
NCT Number NCT03884569
Lead Sponsor Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Collaborators: Citospin, Red de Terapia Celular, University of Valladolid
Conditions
(from sponsor)
Limbal Stem-cell Deficiency
Related terms Limbal Stem Cell Deficiency
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov