Not Yet RecruitingNot Applicable

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

Spain30 participantsStarted 2025-11

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 6 months

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

Timeframe: 6 months

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

Timeframe: 6 months

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

Timeframe: 6 months

Percentage of improvement in corneal conjunctivalization

Timeframe: 6 months

Complete absence of persistent epithelial defects

Timeframe: 6 months

Trial details

NCT IDNCT03884569

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

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-31

Contact for this trial

Margarita Calonge, MD, PhD

34983184750 calonge@ioba.med.uva.es

View on ClinicalTrials.gov More Limbal Stem-cell Deficiency trials

Plain-language summary

What they're measuring

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

Timeframe: 6 months

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

Timeframe: 6 months

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

Timeframe: 6 months

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

Timeframe: 6 months

Percentage of improvement in corneal conjunctivalization

Timeframe: 6 months

Complete absence of persistent epithelial defects

Timeframe: 6 months