Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT03884569

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
Phase
Study type
Observational
Enrollment
30 (estimated)
Sponsor
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2025-11-01
Primary completion
2025-12-31
Completion
2025-12-31
First posted
2019-03-21
Last updated
2025-05-16

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT03884569. Inclusion in this directory is not an endorsement.