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

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

Status: Not yet enrolling

Conditions: Limbal Stem-cell Deficiency

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03884569

IOBA201901

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

30 participants in 1 patient group

Patients treated with CLET

Description:

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.