RecruitingPhase 2NCT06919081
Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Phase II Study of the Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Sponsor
University of Illinois at Chicago
Enrollment
24 participants
Start Date
Aug 1, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria7
- 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 therapy)
- Study Procedures
- Only patients who satisfy all Informed Consent requirements may be included in the study. The patient and/or his/her legal representative must read, sign and date the Informed Consent document before any study-related procedures are performed. The Informed Consent form signed by patients and/or legal representative must have been approved by the UIC IRB for the current study. Patients must have the ability and willingness to comply with study procedures.
Exclusion Criteria9
- Ocular Health
- Any active or suspected ocular infection (bacterial, viral, fungal or protozoal).
- History of any ocular surgery (including laser or refractive surgical procedures) in the study eye within the 3 months prior to study enrollment.
- Treatment with Oxervate in the study eye within 12 months of enrollment.
- Study Procedures
- Known hypersensitivity to one of the components of the study or procedural medications (e.g., fluorescein).
- Use of any investigational agent within 4 weeks of screening visit.
- Participation in another clinical study at the same time as the present study.
- Participants who are pregnant at the time of study enrollment.
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Interventions
DRUGAllogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome
Eye Drops
OTHERVehicle Control
Eye Drops
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06919081