Persistent Corneal Epithelial DefectVision and hearingDrugPhase 2
What this study is
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.
What's being tested
- Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome
Intervention · DRUG
- Vehicle Control
Intervention · OTHER
Both interventions
Eye Drops
Study details
- Official title
- Phase II Study of the Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
- Sponsor
- University of Illinois at Chicago
- Conditions
- Persistent Corneal Epithelial Defect · Corneal Epithelial Disorders
- Enrolling
- 24 people
- Starts
- 2025-08-01
- Est. completion
- 2026-12-15
- Design
- Double-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openUniversity of Illinois at Chicago
Chicago, Illinois, United States
- Jale Yucel · Contact708-752-6905zjyucel@uic.edu
Recruiting
Study team
Sponsor
University of Illinois at Chicago
Study ID 2024-1426
Principal investigator
Ali R Djalilian, MD
University of Illinois at Chicago
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.