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| ID | Type | Description | Link |
|---|---|---|---|
| 3UH3EY031809-04S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome | Experimental | Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome for Topical Eye Drop |
|
| Vehicle | Placebo Comparator | Vehicle (unconditioned media) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome | Drug | Eye Drops |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Percent change in best-corrected distance visual acuity from baseline to DAY 56 as measured using standard ETDRS protocols | Baseline to Day 56 |
| Corneal staining and NEI grading | Grading of fluorescein staining of the cornea Minimum score = 0 Maximum score = 15 Lower score is better |
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Inclusion Criteria:
Age · Patients 18 years of age or older
Ocular Health
Study Procedures
Exclusion Criteria:
Ocular Health
Study Procedures
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ali R Djalilian, MD | Contact | 3129968937 | adjalili@uic.edu | |
| Charlotte E Joslin, OD | Contact | 3129965410 | charjosl@uic.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ali R Djalilian, MD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Recruiting | Chicago | Illinois | 60612 | United States |
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| Vehicle Control | Other | Eye Drops |
|
| Baseline to Day 70 |
| 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 | Baseline to Day 70 |
| 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) | Baseline to Day 70 |
| Subject Symptoms | Changes in ocular discomfort visual analog scale (VAS) 0 - 100, where 0 is no discomfort and 100 the worst discomfort, from baseline to DAY 70 | Baseline to Day 70 |
| Time to epithelial healing | Time of improvement of epitheliopathy | Baseline to Day 70 |
| Corneal Opacities/Scars | Change in the size of corneal opacities and scars (if present) from baseline to DAY 56 as documented by slit lamp photographs | Baseline to Day 56 |
| Corneal vascularization | Change in corneal vascularization on slit lamp photographs from baseline to DAY 56 | Baseline to Day 56 |
| Conjunctival injection | Change in conjunctival injection on slit lamp examination from baseline to DAY 56 | Baseline to Day 56 |
| Subbasal corneal nerve density | Changes in subbasal corneal nerve density on confocal microscopy from baseline to Day 56 | Baseline to Day 56 |
| Ocular Surface Parameters | Changes in Lissamine green staining from baseline to DAY 56 and DAY 70 | Baseline to Day 70 |
| Ocular Surface Parameters | Changes in anesthetic Schirmer's test from baseline to DAY 56 and DAY 70 | Baseline to Day 70 |
| ID | Term |
|---|---|
| D000092423 | Limbal Stem Cell Deficiency |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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