Phase II Study of the Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
University of Illinois at Chicago
Summary
In this phase II randomized double-masked clinical trials, subjects with non-resolving corneal epithelial disease/defect (i.e., refractory to standard treatments for at least two weeks) will receive 8 weeks treatment of topical mesenchymal stem cell secretome or vehicle, with continued follow-up for up to Day 70.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age · Patients 18 years of age or older * Ocular Health * Chronic corneal epithelial disease with fluorescein staining score 6 by NEI grading scale or persistent corneal epithelial defect present for longer than 14 days despite standard treatment * No objective clinical evidence of significant (\> 50%) improvement/worsening of the epithelial disease in the last 14 days * Epithelial disease refractory to conventional non-surgical treatments (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops; anti-inflammatory th…
Interventions
- DrugAllogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome
Eye Drops
- OtherVehicle Control
Eye Drops
Location
- University of Illinois at ChicagoChicago, Illinois