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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

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Conditions

Persistent Corneal Epithelial DefectCorneal Epithelial Disorders

Locations

University of Illinois at Chicago

Chicago, Illinois 60612

United States