NCT06919081 Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
| NCT ID | NCT06919081 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Illinois at Chicago |
| Condition | Persistent Corneal Epithelial Defect |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2025-08-01 with a primary completion date of 2026-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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.
Contact & Investigator
Ali R Djalilian, MD
PRINCIPAL INVESTIGATOR
University of Illinois at Chicago
Frequently Asked Questions
Who can join the NCT06919081 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Persistent Corneal Epithelial Defect. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06919081 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06919081 currently recruiting?
Yes, NCT06919081 is actively recruiting participants. Contact the research team at adjalili@uic.edu for enrollment information.
Where is the NCT06919081 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06919081 clinical trial?
NCT06919081 is sponsored by University of Illinois at Chicago. The principal investigator is Ali R Djalilian, MD at University of Illinois at Chicago. The trial plans to enroll 24 participants.