Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease

Phase II Study of the Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease

In this phase II randomized double-masked clinical trials, subjects with non-resolving corneal epithelial disease/defect (i.e., refractory to standard treatments for at least two weeks) will receive 8 weeks treatment of topical mesenchymal stem cell secretome or vehicle, with continued follow-up for up to Day 70.

Study Overview

• Status: Recruiting
• Conditions: Persistent Corneal Epithelial Defect; Corneal Epithelial Disorders
• Intervention / Treatment: Drug: Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome; Other: Vehicle Control

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ali R Djalilian, MD; Phone Number: 3129968937; Email: adjalili@uic.edu
• Study Contact Backup: Name: Charlotte E Joslin, OD; Phone Number: 3129965410; Email: charjosl@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois at Chicago
      • Contact: Jale Yucel; Phone Number: 708-752-6905; Email: zjyucel@uic.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age · Patients 18 years of age or older

• Ocular Health

  • Chronic corneal epithelial disease with fluorescein staining score 6 by NEI grading scale or persistent corneal epithelial defect present for longer than 14 days despite standard treatment
  • No objective clinical evidence of significant (> 50%) improvement/worsening of the epithelial disease in the last 14 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)
  • If both eyes of subject meet the inclusion criteria, the eye with the higher fluorescein staining score will be enrolled to the study.

• Study Procedures

  • Only patients who satisfy all Informed Consent requirements may be included in the study. The patient and/or his/her legal representative must read, sign and date the Informed Consent document before any study-related procedures are performed. The Informed Consent form signed by patients and/or legal representative must have been approved by the UIC IRB for the current study. Patients must have the ability and willingness to comply with study procedures.

Exclusion Criteria:

• Ocular Health

  • Any active or suspected ocular infection (bacterial, viral, fungal or protozoal).
  • History of any ocular surgery (including laser or refractive surgical procedures) in the study eye within the 3 months prior to study enrollment.
  • Treatment with Oxervate in the study eye within 12 months of enrollment.

• Study Procedures

  • Known hypersensitivity to one of the components of the study or procedural medications (e.g., fluorescein).
  • Use of any investigational agent within 4 weeks of screening visit.
  • Participation in another clinical study at the same time as the present study.
  • Participants who are pregnant at the time of study enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome; Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome for Topical Eye Drop	Drug: Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome; Eye Drops
Placebo Comparator: Vehicle; Vehicle (unconditioned media)	Other: Vehicle Control; Eye Drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of Corneal Epithelial Barrier and/or Integrity (Efficacy Outcome)	Proportion of subjects with improved epithelial barrier and/or integrity from baseline to DAY 56 as determined by the investigator on slit lamp examination: · Improved epithelial barrier, defined as ³ 50 % improvement in corneal fluorescein staining score using NEI grading scale · Improved epithelial integrity, defined as complete closure of persistent epithelial defect, measured with ImageJ on slit lamp images	Baseline to Day 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Percent change in best-corrected distance visual acuity from baseline to DAY 56 as measured using standard ETDRS protocols	Baseline to Day 56
Corneal staining and NEI grading	Grading of fluorescein staining of the cornea Minimum score = 0 Maximum score = 15 Lower score is better	Baseline to Day 70
Ocular Surface Parameters	Changes in ocular surface disease index (OSDI) from baseline to DAY 56 and DAY 70 Minimum value = 0 Maximum value = 100 Lower value is better	Baseline to Day 70
Corneal Epithelial Thickness	Percent change in corneal epithelial thickness from baseline to DAY 56 and DAY 70, as measured by anterior segment OCT (AS-OCT)	Baseline to Day 70
Subject Symptoms	Changes in ocular discomfort visual analog scale (VAS) 0 - 100, where 0 is no discomfort and 100 the worst discomfort, from baseline to DAY 70	Baseline to Day 70
Time to epithelial healing	Time of improvement of epitheliopathy	Baseline to Day 70
Corneal Opacities/Scars	Change in the size of corneal opacities and scars (if present) from baseline to DAY 56 as documented by slit lamp photographs	Baseline to Day 56
Corneal vascularization	Change in corneal vascularization on slit lamp photographs from baseline to DAY 56	Baseline to Day 56
Conjunctival injection	Change in conjunctival injection on slit lamp examination from baseline to DAY 56	Baseline to Day 56
Subbasal corneal nerve density	Changes in subbasal corneal nerve density on confocal microscopy from baseline to Day 56	Baseline to Day 56
Ocular Surface Parameters	Changes in Lissamine green staining from baseline to DAY 56 and DAY 70	Baseline to Day 70
Ocular Surface Parameters	Changes in anesthetic Schirmer's test from baseline to DAY 56 and DAY 70	Baseline to Day 70

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Eye Institute (NEI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Ali R Djalilian, MD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): March 15, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: neurotrophic keratitis; limbal stem cell deficiency; persistent corneal epithelial disease/defects; persistent corneal epithelial; corneal epithelial disease
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Limbal Stem Cell Deficiency
• Other Study ID Numbers: 2024-1426; 3UH3EY031809-04S1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No