Topical mesenchymal stem cell secretions for persistent corneal epithelial defects

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

This trial will test whether eye drops made from bone-marrow mesenchymal stem cell secretions can help adults whose corneal epithelial defects have not healed with standard treatments.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Illinois at Chicago (other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT06919081 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-masked Phase 2 trial comparing topical allogeneic bone-marrow-derived mesenchymal stromal cell secretome versus a vehicle control in adults with non-resolving corneal epithelial disease. Eligible participants have defects present longer than 14 days and meeting a fluorescein staining threshold, and will receive treatment for 8 weeks with follow-up through Day 70. The trial will monitor corneal epithelial healing and safety outcomes over the treatment and follow-up period. The intervention is administered as topical eye drops and is designed for cases refractory to conventional non-surgical therapies.

Who should consider this trial

Good fit: Adults (18+) with persistent corneal epithelial defects present for more than 14 days despite standard non-surgical treatments and meeting the trial's fluorescein staining criteria are the intended participants.

Not a fit: Patients whose defects are new (<14 days), are already clearly improving or worsening in the prior 14 days, require surgical intervention, or who are under 18 are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the treatment could speed healing of persistent corneal epithelial defects and reduce complications such as infection or vision loss.

How similar studies have performed: Early laboratory and small clinical studies of mesenchymal stromal cell secretome for corneal healing have shown promising signals, but larger randomized trials remain limited.

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.

Where this trial is running

Chicago, Illinois

• University of Illinois at Chicago — Chicago, Illinois, United States (RECRUITING)

Study contacts

• Principal investigator: Ali R Djalilian, MD — University of Illinois at Chicago
• Study coordinator: Ali R Djalilian, MD

Conditions: Persistent Corneal Epithelial Defect, Corneal Epithelial Disorders, persistent corneal epithelial disease/defects, persistent corneal epithelial, corneal epithelial disease, limbal stem cell deficiency, neurotrophic keratitis