Clinical Trials Logo

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
Email adjalili@uic.edu
Status Recruiting
Phase Early Phase 1
Start date January 24, 2024
Completion date July 1, 2025

See also
  Status Clinical Trial Phase
Terminated NCT03674892 - Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain N/A
Recruiting NCT04439552 - fMRI and IVCM Cornea Microscopy of CXL in Keratoconus
Not yet recruiting NCT04122651 - Toric Intraocular Lenses for Cataract Patients in the NHS N/A
Recruiting NCT03299530 - Accuracy of Corneal Astigmatism in Different Region Modes
Completed NCT04560790 - Safety and Efficacy of CRISPR/Cas9 mRNA Instantaneous Gene Editing Therapy to Treat Refractory Viral Keratitis N/A
Recruiting NCT03010748 - Multi-center Clinical Trial on Corneal Morphology Analysis in Chinese Population
Completed NCT02293122 - To Investigate Agreement Between the EM-3000 and the Predicate Device Noncon Robo Pachy (F&A) (CellChek XL)
Active, not recruiting NCT06389916 - Euclid Phoenix Lens Design Trial N/A
Completed NCT06353776 - MicroPulse Transscleral Laser Therapy and Its Short-term Impact on Ocular Surface N/A
Completed NCT03906513 - Evaluation of the Efficacy of OMK2 in Recovering Corneal Neural Damage in Patients With Diabetes N/A
Not yet recruiting NCT06392607 - Euclid Phoenix Lens Design Trial 2 N/A
Recruiting NCT05232539 - Efficiency of Intraoperative Optical Coherence Tomography (iOCT) N/A
Completed NCT02781948 - Evaluation of the Repeatability and Reproducibility of Corneal Epithelial Thickness Mapping With iVue SD-OCT N/A
Not yet recruiting NCT05345652 - Evaluation Of Deep Anterior Lamellar Keratoplasty By Anterior Segment Ocular Coherence Tomography
Completed NCT04804592 - Investigation in Corneal Sensation and Contact Lens Wear N/A
Recruiting NCT04626583 - Safety of Locally Delivered Allogeneic Mesenchymal Stromal Cells Phase 1
Recruiting NCT04323358 - Agreement and Accuracy of Different Devices for Biometry Measurements in Patients With Cataract N/A
Completed NCT06277349 - Multifocal-toric IOL Compared to Multifocal IOL Combined With Limbal Relaxing Incisions for Correction of Moderate Astigmatism During Cataract Surgery N/A
Withdrawn NCT02395952 - Healing of Persistent Epithelial Defects N/A
Completed NCT03518775 - Repeatability and Reproducibility of the IOLMaster 700 Vers 1.70 and Agreement With IOLMaster 700 Vers. 1.50 and Pentacam