Safety of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease

Completed · Early Phase 1

Conditions studied: Mesenchymal Stromal Cells, Cornea, Corneal Defect, Corneal Epithelium Defect

In brief

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.

Key facts

Study ID

NCT05204329

Run by

University of Illinois at Chicago

People needed

9

Starts

2024-01-24

Expected to finish

2024-11-08

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Illinois at Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.