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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome
DrugEye Drops
Vehicle Control
Other interventionEye Drops
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells SecretomeExperimental treatment 1 intervention
Group B: VehiclePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Improvement of Corneal Epithelial Barrier and/or Integrity (Efficacy Outcome)
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
Time frame
Baseline to Day 56Secondary outcomes
1
Visual Acuity
Percent change in best-corrected distance visual acuity from baseline to DAY 56 as measured using standard ETDRS protocols
Time frame
Baseline to Day 562
Corneal staining and NEI grading
Grading of fluorescein staining of the cornea Minimum score = 0 Maximum score = 15 Lower score is better
Time frame
Baseline to Day 703
Ocular Surface Parameters
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
Time frame
Baseline to Day 704
Corneal Epithelial Thickness
Percent change in corneal epithelial thickness from baseline to DAY 56 and DAY 70, as measured by anterior segment OCT (AS-OCT)
Time frame
Baseline to Day 70Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Illinois at Chicago
Lead sponsor
National Eye Institute (NEI)
Collaborator
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov