Persistent Corneal Epithelial DefectPhase 2NCT06919081
Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
A Phase 2 study testing Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome in people with Persistent Corneal Epithelial Defect and Corneal Epithelial Disorders, run by University of Illinois Chicago at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Corneal Epithelial Defect, Corneal Epithelial Disorders
- What is being tested?
- Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 15 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
Jale Yucel, 708-752-6905, zjyucel@uic.edu
About this study
Official title: Phase II Study of the Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
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.
- Being tested
- Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome, Vehicle Control
- Keywords
- persistent corneal epithelial disease/defects, persistent corneal epithelial, corneal epithelial disease, limbal stem cell deficiency, neurotrophic keratitis
- Medical subject headings
- Limbal Stem Cell Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells SecretomeDrug
Eye Drops
Vehicle ControlOther
Eye Drops
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome | Experimental | Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome for Topical Eye Drop Receives: Drug: Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome |
| Vehicle | Placebo comparator | Vehicle (unconditioned media) Receives: Other: Vehicle Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to Day 56
Secondary outcomes (12)
Visual Acuity
Percent change in best-corrected distance visual acuity from baseline to DAY 56 as measured using standard ETDRS protocols
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: Baseline to Day 70
Time to epithelial healing
Time of improvement of epitheliopathy
Measured: 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
Measured: Baseline to Day 56
Corneal vascularization
Change in corneal vascularization on slit lamp photographs from baseline to DAY 56
Measured: Baseline to Day 56
Conjunctival injection
Change in conjunctival injection on slit lamp examination from baseline to DAY 56
Measured: Baseline to Day 56
Subbasal corneal nerve density
Changes in subbasal corneal nerve density on confocal microscopy from baseline to Day 56
Measured: Baseline to Day 56
Ocular Surface Parameters
Changes in Lissamine green staining from baseline to DAY 56 and DAY 70
Measured: Baseline to Day 70
Ocular Surface Parameters
Changes in anesthetic Schirmer's test from baseline to DAY 56 and DAY 70
Measured: Baseline to Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Aug 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Corneal Epithelial DefectStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Ali R Djalilian, University of Illinois Chicago
- Investigators
- Ali R Djalilian, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919081
- Sponsor's protocol ID
- 2024-1426
- Other IDs
- 3UH3EY031809-04S1
- Status last verified
- May 2026
- First submitted
- 25 Mar 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of the Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
- ClinicalTrials.gov ID
- NCT06919081
- Acronym / sponsor ID
- 2024-1426
- Keywords
- persistent corneal epithelial disease/defects, persistent corneal epithelial, corneal epithelial disease, limbal stem cell deficiency, neurotrophic keratitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI), National Institutes of Health (NIH)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome | Experimental | Drug: Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells SecretomeAllogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome for Topical Eye Drop |
| Vehicle | Placebo comparator | Other: Vehicle ControlVehicle (unconditioned media) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age · Patients 18 years of age or older
- Ocular Health
- Study Procedures
Key exclusion criteria (9 listed)
- Ocular Health
- Study Procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells SecretomeEye Drops | Drug | Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome |
| Vehicle ControlEye Drops | Other | Vehicle |
Primary outcome
Improvement of Corneal Epithelial Barrier and/or Integrity (Efficacy Outcome)
Time frame: Baseline to Day 56
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
12 secondary outcomes
Visual Acuity
Time frame: Baseline to Day 56
Corneal staining and NEI grading
Time frame: Baseline to Day 70
Ocular Surface Parameters
Time frame: Baseline to Day 70
Corneal Epithelial Thickness
Time frame: Baseline to Day 70
Subject Symptoms
Time frame: Baseline to Day 70
Time to epithelial healing
Time frame: Baseline to Day 70
Corneal Opacities/Scars
Time frame: Baseline to Day 56
Corneal vascularization
Time frame: Baseline to Day 56
Conjunctival injection
Time frame: Baseline to Day 56
Subbasal corneal nerve density
Time frame: Baseline to Day 56
Ocular Surface Parameters
Time frame: Baseline to Day 70
Ocular Surface Parameters
Time frame: Baseline to Day 70
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali R Djalilian, MD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome in people with Persistent Corneal Epithelial Defect and Corneal Epithelial Disorders, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali R Djalilian, MD (3129968937, adjalili@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Corneal Epithelial Barrier and/or Integrity (Efficacy Outcome) (time frame: Baseline to Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.