Actively Recruiting
Phase II Study of the Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Led by University of Illinois at Chicago · Updated on 2026-01-29
24
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University of Illinois at Chicago
Lead Sponsor
N
National Eye Institute (NEI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of topical mesenchymal stromal cell secretome in adults with persistent corneal epithelial disease that has not improved with standard treatments for at least two weeks. This phase II randomized, double-masked clinical trial aims to assess whether this treatment can improve corneal epithelial barrier and integrity. Participants have corneal epithelial disorders that are resistant to conventional non-surgical therapies. Participants will be randomly assigned to receive either the experimental eye drops containing allogeneic bone-marrow derived mesenchymal stromal cell secretome or a placebo vehicle eye drop. Treatment is given for 8 weeks, followed by continued monitoring up to day 70. The study includes two groups: one receiving the stem cell secretome eye drops and the other receiving unconditioned media as a vehicle control. During the study, participants will undergo assessments including visual acuity tests, corneal staining and grading, ocular surface evaluations, corneal thickness measurements, symptom tracking, and healing time monitoring. Safety and efficacy will be evaluated through various ocular surface parameters, corneal opacities, vascularization, and nerve density measures from baseline through day 70. The total participation lasts about 10 weeks, including treatment and follow-up visits.
CONDITIONS
Brief Title
Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- 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 significant improvement or worsening of the epithelial disease in the last 14 days
- Epithelial disease refractory to conventional non-surgical treatments such as preservative-free artificial tears, gels, ointments, or anti-inflammatory therapy
- If both eyes qualify, the eye with the higher fluorescein staining score will be enrolled
- Ability and willingness to comply with study procedures
- Signed informed consent approved by the UIC IRB
You will not qualify if you...
- Any active or suspected ocular infection (bacterial, viral, fungal, or protozoal)
- History of ocular surgery, including laser or refractive procedures, in the study eye within 3 months prior to enrollment
- Treatment with Oxervate in the study eye within 12 months prior to enrollment
- Known hypersensitivity to components of study or procedural medications such as fluorescein
- Use of any investigational agent within 4 weeks of screening
- Participation in another clinical study simultaneously
- Pregnancy at the time of enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 56 days
Participants receive topical eye drops of either the mesenchymal stromal cell secretome or a vehicle control to treat ocular surface disease.
Baseline visit and multiple follow-up visits through Day 56
Duration - up to 14 days after treatment (through Day 70)
Participants are monitored for ocular surface parameters and healing outcomes after treatment ends.
Follow-up visits up to Day 70
Trial Site Locations
Total: 1 location
1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
A
Ali R Djalilian, MD
C
Charlotte E Joslin, OD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here