NCT06919081PHASE2Recruiting
Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
University of Illinois at Chicago
Start Date
8/1/2025
Completion Date
6/15/2026
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 Criteria
Age Range: 18 years to No maximum
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 therapy)
* If both eyes of subject meet the inclusion criteria, the eye with the higher fluorescein staining score will be enrolled to the study.
* 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 Criteria:
* 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.
Interventions
DRUG
Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome
OTHER
Vehicle Control
Conditions
Persistent Corneal Epithelial DefectCorneal Epithelial Disorders
Locations
University of Illinois at Chicago
Chicago, Illinois 60612
United States