Safety of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
NCT05204329 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2026-01-29
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 conducted at Illinois Eye and Ear Infirmary located at University of Illinois at Chicago. The study will use anterior segment Optical Coherence Tomography (OCT)/Scheimpflug Imaging, esthesiometry, and visual analogue scale (VAS) to assess treatment tolerability.
Conditions
- Mesenchymal Stromal Cells
- Cornea
- Corneal Defect
- Corneal Epithelium Defect
Interventions
- BIOLOGICAL
-
MSC Secretome Eye Drops
MSC Secretome eye drop will be dispensed.
Sponsors & Collaborators
-
National Eye Institute (NEI)
collaborator NIH -
National Institutes of Health (NIH)
collaborator NIH -
University of Illinois at Chicago
lead OTHER
Principal Investigators
-
Ali R Djalilian, MD · University of Illinois at Chicago
-
Charlotte E Joslin, OD, PhD · University of Illinois at Chicago
-
Elmer Y Tu, MD · University of Illinois at Chicago
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-24
- Primary Completion
- 2024-11-08
- Completion
- 2024-11-08
- FDA Drug
- Yes
Countries
- United States
Study Locations
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