Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome
- Vehicle Control
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Illinois at Chicago
Lead sponsor
National Eye Institute (NEI)
Collaborator
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov