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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03884569

Acronym

CLET-4-LSCD

Enrollment

Registered

2019-03-21

Start date

2025-11-30

Completion date

2025-12-31

Last updated

2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Limbal Stem-cell Deficiency

Keywords

limbal stem cell deficiency, corneal failure, limbal epithelial stem cells, ocular surface, corneal blindness

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Points of improvement in the Single Item Dry Eye Questionnaire (SIDEQ)	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.
Points of improvement about the Ocular Surface Disease Index (OSDI)	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.
Points of improvement in the National Eye Institute 25-item Visual Function Questionnaire (NEI-VFQ25)	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.
Points of improvement in the Change in Dry Eye Symptoms Questionnaire (CDES-Q)	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.
Percentage of improvement in corneal conjunctivalization	6 months	Percentage of corneal area with conjunctivalization (superficial opacity and/or superficial neovascularization) will be measured.
Complete absence of persistent epithelial defects	6 months	Corneal fluorescein staining has to rule out epithelial breakdown

Countries

Spain

Contacts

Primary ContactMargarita Calonge, MD, PhD

calonge@ioba.med.uva.es34983184750

Outcome results