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.
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 patients with chronic ocular surface disease through a dose-escalation study under a 28-day topical application protocol, and also obtain a preliminary observation on the following: 1. Incidence of treatment emergent adverse events (TEAE) assessed at 28 days following treatment initiation 2. Proportion of patients with improved corneal epithelial barrier at 28 days compared to baseline 3. Final visual acuity, corneal epithelial thickness, corneal stromal haze, corneal sensation, and treatment tolerability The objective is to determine the dose of MSC Secretome through a first-in-human study through a dose-escalation strategy targeting a toxicity rate of 33% or less.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
MSC Secretome eye drop will be dispensed.
University of Illinois at Chicago
Chicago, Illinois, United States
Epithelial Status Assessment
The primary outcome measure is improved corneal epithelial barrier function at DAY #28assessed by viewing the cornea under slit lamp examination after instillation of sodium fluorescein, assessing the change from baseline in corneal fluorescein staining score. The presence/absence of an epithelial defect on DAY #28 will also be recorded.
Time frame: Day 28
Visual Acuity
Best-corrected distance visual acuity will be measured using standard ETDRS protocols.
Time frame: Baseline, Days 7, 14, 28, 56, 90
Corneal Epithelial thickness
Corneal epithelial thickness measured by anterior segment OCT imaging (Cirrus 6000, Pachymetry, a-scans and b-scans) will assess the treatment effect on thickness on DAY #28 and compared relative to baseline.
Time frame: Baseline, Days 14, 28, 56, 90
Corneal Scarring / Haze
Corneal scarring/haze will be assessed via anterior segment OCT imaging (Cirrus 6000; HD cornea, a-scans) to assess the treatment effect on DAY #28 relative to baseline(Images analysis done by Image-J/Metamorph)
Time frame: Baseline, Days 14, 28, 56, 90
Tolerability of MSC secretome drops
Drop discomfort will be measured at DAYS #7, #14, and #28 using a visual analogue scale (VAS; range 0 -100), where 0 represents no discomfort and 100 the worst discomfort.
Time frame: Baseline, Days 7, 14, 28, 56, 90
Durability of Corneal Epithelial Status Improvement
Durability of the improved corneal epithelial barrier function/integrity will be assessed an outcome measure at DAY #56 and DAY #90. Participants with improved corneal epithelial barrier function/integrity to DAY #28 will be assessed at each subsequent follow-up visits (e.g., DAYS #56, #90) to assess persistence of the healing response.
Time frame: Baseline, Days 7, 14, 28, 56, 90
Time to Improvement of Corneal Epithelial Barrier
The time required for an improved epithelial barrier function will be assessed at each visit throughout the trial.
Time frame: Baseline, Days 7, 14, 28, 56, 90
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