Allogeneic ABCB5-positive Limbal Stem Cells for Treatment of LSCD (NCT03549299) | Clinical Trial Compass
UnknownPhase 1/2
Allogeneic ABCB5-positive Limbal Stem Cells for Treatment of LSCD
United States, Germany16 participantsStarted 2019-07-04
Plain-language summary
The aim of this clinical trial is to investigate the efficacy (by monitoring neovascularization and epithelial defects) of up to four doses of the investigational medicinal product (IMP) LSC2 topically administered on the target eye of patients with LSCD. Further, safety of the IMP during and after application will be investigated (by monitoring adverse events \[AEs\]).
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Male or female patients aged 18 to 85 years
✓. Patients with secondary bilateral or unilateral LSCD (injury that caused LSCD at least 6 months prior to inclusion)
✓. Neovascularization: Vessel penetration of at least 2 quadrants, with central cornea involved
✓. Patients understand the nature of the procedure and are providing written informed consent prior to any clinical trial procedure
✓. Women of childbearing potential must have a negative blood pregnancy test at Visit 1
✓. Women of childbearing potential must be willing to use highly effective contraceptive methods during the course of the clinical trial
Exclusion criteria
✕. Compromised eyelid mobility and/or symblepharon; patient can be re-screened after appropriate treatment
✕. Presence of eyelid malposition; patient can be re-screened after appropriate treatment
✕. Active local ocular or systemic infection and/or inflammation. Patient can be re-screened after infection and/or inflammation is resolved.
✕. Tumor diseases or history of tumor disease
✕. Active ocular neoplastic disease (exclusion will be based on investigator's assessment)
✕. Corneal erosion or ulcer is bigger than 4 mm2; corresponding to less than 95% of continuous corneal epithelium. Patient can be re-screened after erosion or ulcer is resolved (≤ 4 mm2).