Topical mesenchymal stem cell secretions for persistent corneal epithelial defects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Principal investigator: Ali R Djalilian, MD — University of Illinois Chicago
• Study coordinator: Ali R Djalilian, MD
• Email: adjalili@uic.edu
• Phone: 3129968937

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• TP-06 for Persistent Corneal Epithelial Defects: see if healing improves

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• Efficacy and safety of cenegermin eye drops for persistent corneal epithelial defects

  This study tests whether cenegermin eye drops can heal persistent corneal epithelial defects better than a vehicle in adults with PCED.

  Recruiting at 51 sites Phase 3 Dompé Farmaceutici S.p.A · Huntington Beach, California and 76 other locations · NCT07519902

• Evaluating NEXAGON® for treating persistent corneal epithelial defects

  This study is testing if NEXAGON® eye gel can help people with stubborn corneal problems that haven't improved with regular treatments.

  Recruiting at 28 sites Phase 2 Glaukos Corporation · Dothan, Alabama and 27 other locations · NCT05966493

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.