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NCT Number: NCT06919081

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location status: Recruiting

Location contact

Jale Yucel

CONTACT

[email protected]

708-752-6905

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome

Drug

Eye Drops

Vehicle Control

Other

Eye Drops

Primary outcomes

  1. Improvement of Corneal Epithelial Barrier and/or Integrity (Efficacy Outcome)

    Time frame: Baseline to Day 56

    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

Secondary outcomes

  1. Visual Acuity

    Time frame: Baseline to Day 56

    Percent change in best-corrected distance visual acuity from baseline to DAY 56 as measured using standard ETDRS protocols

  2. Corneal staining and NEI grading

    Time frame: Baseline to Day 70

    Grading of fluorescein staining of the cornea Minimum score = 0 Maximum score = 15 Lower score is better

  3. Ocular Surface Parameters

    Time frame: Baseline to Day 70

    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

  4. Corneal Epithelial Thickness

    Time frame: Baseline to Day 70

    Percent change in corneal epithelial thickness from baseline to DAY 56 and DAY 70, as measured by anterior segment OCT (AS-OCT)

  5. Subject Symptoms

    Time frame: Baseline to Day 70

    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

  6. Time to epithelial healing

    Time frame: Baseline to Day 70

    Time of improvement of epitheliopathy

  7. Corneal Opacities/Scars

    Time frame: Baseline to Day 56

    Change in the size of corneal opacities and scars (if present) from baseline to DAY 56 as documented by slit lamp photographs

  8. Corneal vascularization

    Time frame: Baseline to Day 56

    Change in corneal vascularization on slit lamp photographs from baseline to DAY 56

  9. Conjunctival injection

    Time frame: Baseline to Day 56

    Change in conjunctival injection on slit lamp examination from baseline to DAY 56

  10. Subbasal corneal nerve density

    Time frame: Baseline to Day 56

    Changes in subbasal corneal nerve density on confocal microscopy from baseline to Day 56

  11. Ocular Surface Parameters

    Time frame: Baseline to Day 70

    Changes in Lissamine green staining from baseline to DAY 56 and DAY 70

  12. Ocular Surface Parameters

    Time frame: Baseline to Day 70

    Changes in anesthetic Schirmer's test from baseline to DAY 56 and DAY 70

Study contacts

Contact information is provided by the study sponsor or research team.

Ali R Djalilian, MD

CONTACT

[email protected]

3129968937

Charlotte E Joslin, OD

CONTACT

[email protected]

3129965410

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Eye Institute (NEI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2025
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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