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Cultivated Limbal Epithelial Transplantation (CLET) for Limbal Stem Cell Deficiency (LSCD) (CLET-4-LSCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884569
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Collaborators:
Citospin
Red de Terapia Celular
University of Valladolid
Information provided by (Responsible Party):
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

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.

Condition or disease
Limbal Stem-cell Deficiency

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Cultivated Limbal Epithelial Transplantation (CLET) for Limbal Stem Cell Deficiency (LSCD): an Observational Study on Safety and Effectiveness
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Group/Cohort
Patients treated with CLET
Previously treated with CLET patients are included retrospectively, as the follow-up procedure is already stablished in our centre, and patients treated following standard care or through "drugs-in-special-situation" request in Spain prospectively. Patients are not treated to be included in the study, only the follow-up variables are taken into account.



Primary Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with corneal failure due to LSCD who accept and sign the informed written consent treatment to be treated with CLET
Criteria
Total and/or severe LSCD of any etiology in one or both eyes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884569


Contacts
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Contact: Margarita Calonge, MD, PhD 34983184750 calonge@ioba.med.uva.es

Locations
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Spain
IOBA
Valladolid, Spain, 47011
Contact: Margarita Calonge, MD, PhD         
Principal Investigator: Margarita Calonge, MD, PhD         
Sponsors and Collaborators
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Citospin
Red de Terapia Celular
University of Valladolid
Publications of Results:

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Responsible Party: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
ClinicalTrials.gov Identifier: NCT03884569    
Other Study ID Numbers: IOBA201901
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA:
limbal stem cell deficiency
corneal failure
limbal epithelial stem cells
ocular surface
corneal blindness