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Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease

RecruitingPhase 2

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: University of Illinois at Chicago · Participants: 24 · Started: Aug 1, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06919081

Locations in the U.S.

IllinoisUniversity of Illinois at Chicago, Chicago

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.