Status:
COMPLETED
Safety of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
National Eye Institute (NEI)
National Institutes of Health (NIH)
Conditions:
Mesenchymal Stromal Cells
Cornea
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This study is a longitudinal assessment using a classic dose-escalation study design to assess the safety and maximal tolerated dose (MTD) of topical MSC Secretome eye drops. The study will be conduct...
Detailed Description
The "Safety of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease" study is designed to evaluate the safety and maximal tolerated dose (MTD) of topical MSC Secretome eye drops in pa...
Eligibility Criteria
Inclusion
- Patients 18 years of age or older
- Chronic corneal epithelial disease with fluorescein staining score ≥ 6 by NEI grading scale
- Reduced corneal sensation (≤ 4 cm measured by Cochet Bonnet esthesiometry) in at least one corneal quadrant
- A stable ocular surface with no objective clinical evidence of significant (\> 50%) improvement/worsening of the epithelial disease in the last 30 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)
Exclusion
- Any active or suspected ocular infection (bacterial, viral, fungal or protozoal).
- Evidence of corneal ulceration with stromal loss \> 10%
- Presence of an epithelial defect ≥1.0 mm in the largest diameter in the affected eye
- Presence of any size epithelial defect that has been persistent for more than 30 days
- Patients unable to discontinue or intermittently remove therapeutic contact lens in the study eye (to apply drops) during the 4-week study period
- History of any ocular surgery (including laser or refractive surgical procedures) in the affected eye within the 3 months prior to study enrollment
- History of chemical injury within the last 6 months prior to study enrollment Known hypersensitivity to one of the components of the study or procedural medications (e.g.,fluorescein)
- History of drug, medication or alcohol abuse or addiction
- Use of any investigational agent within 4 weeks of screening visit
- History of previous enrollment in the MSC Secretome Study at a lower dose
- Participation in another clinical study at the same time as the present study
- Participants who are pregnant at the time of study enrollment
Key Trial Info
Start Date :
January 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05204329
Start Date
January 24 2024
End Date
November 8 2024
Last Update
December 16 2024
Active Locations (1)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612