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NCT Number: NCT03884569

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

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.

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Key information

Conditions

Limbal Stem-cell Deficiency Corneal Diseases Eye Diseases Limbal Stem Cell Deficiency

Sex eligibility

All sexes

Study type

Observational

Primary location

IOBA

Valladolid, 47011, Spain

Location contact

Margarita Calonge, MD, PhD

CONTACT

Margarita Calonge, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Total and/or severe LSCD of any etiology in one or both eyes.

Treatment and study plan

Primary outcomes

  1. Points of improvement in the Single Item Dry Eye Questionnaire (SIDEQ)

    Time frame: 6 months

    The SIDEQ gives a 0-4 score about the presence of dryness, foreign body sensation, burning/stinging, pain, itching, sensitivity to light, and blurred vision, where higher scores indicate higher intensity of the symptom (maximun score: 28). One of the primary outcomes for this work is the improvement in any of the four questionnaires shown here.

  2. Points of improvement about the Ocular Surface Disease Index (OSDI)

    Time frame: 6 months

    The OSDI evaluates ocular surface symptoms with 12 questions, and scores >12 indicate abnormal symptomatology, and >32 means severe symptoms (maximum score 100). One of the primary outcomes for this work is the improvement in any of the four questionnaires shown here.

  3. Points of improvement in the National Eye Institute 25-item Visual Function Questionnaire (NEI-VFQ25)

    Time frame: 6 months

    The visual function-related aspects of the quality of life were evaluated with the NEI-VFQ25, where higher scores on a 0 to 100 scale indicate better function. One of the primary outcomes for this work is the improvement in any of the four questionnaires shown here.

  4. Points of improvement in the Change in Dry Eye Symptoms Questionnaire (CDES-Q)

    Time frame: 6 months

    The CDES-Q evaluates ocular surface symptoms with two questions, CDES-Q1 and CDES-Q2. CDES-Q1 evaluates the change in symptoms occured since the previous examination (same, better or worse). CDES-Q2 evaluates the magnitude of the change in a scale from 0 to 10, where 0 means "slightly better/worse" and 10 means "extremely better/worse". One of the primary outcomes for this work is the improvement in any of the four questionnaires shown here.

  5. Percentage of improvement in corneal conjunctivalization

    Time frame: 6 months

    Percentage of corneal area with conjunctivalization (superficial opacity and/or superficial neovascularization) will be measured.

  6. Complete absence of persistent epithelial defects

    Time frame: 6 months

    Corneal fluorescein staining has to rule out epithelial breakdown

Study contacts

Contact information is provided by the study sponsor or research team.

Margarita Calonge, MD, PhD

CONTACT

[email protected]

34983184750

Sponsors and collaborators

Lead sponsor

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

Other

Collaborators

  • Citospin
  • Red de Terapia Celular
  • University of Valladolid

Registry information

Official study title

Cultivated Limbal Epithelial Transplantation (CLET) for Limbal Stem Cell Deficiency (LSCD): an Observational Study on Safety and Effectiveness

Acronym: CLET-4-LSCD

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2019
Registry last updated
May 16, 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.

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