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Clinical Trial 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.

Clinical Trial 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 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 Design

Related Conditions & MeSH terms

NCT number NCT05204329
Study type Interventional
Source University of Illinois at Chicago
Contact Ali R Djalilian, MD
Phone 312-996-8937
Status Recruiting
Phase Early Phase 1
Start date January 24, 2024
Completion date July 1, 2025

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