Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease

January 27, 2026 updated by: Ali R Djalilian, University of Illinois at Chicago

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois at Chicago
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome
Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome for Topical Eye Drop
Drug: Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome
Eye Drops
Placebo Comparator: Vehicle
Vehicle (unconditioned media)
Other: Vehicle Control
Eye Drops

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline to Day 56

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: Baseline to Day 56
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
Time Frame: Baseline to Day 70
Grading of fluorescein staining of the cornea Minimum score = 0 Maximum score = 15 Lower score is better
Baseline to Day 70
Ocular Surface Parameters
Time Frame: Baseline to Day 70
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
Time Frame: Baseline to Day 70
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
Time Frame: Baseline to Day 70
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 Frame: Baseline to Day 70
Time of improvement of epitheliopathy
Baseline to Day 70
Corneal Opacities/Scars
Time Frame: Baseline to Day 56
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
Time Frame: Baseline to Day 56
Change in corneal vascularization on slit lamp photographs from baseline to DAY 56
Baseline to Day 56
Conjunctival injection
Time Frame: Baseline to Day 56
Change in conjunctival injection on slit lamp examination from baseline to DAY 56
Baseline to Day 56
Subbasal corneal nerve density
Time Frame: Baseline to Day 56
Changes in subbasal corneal nerve density on confocal microscopy from baseline to Day 56
Baseline to Day 56
Ocular Surface Parameters
Time Frame: Baseline to Day 70
Changes in Lissamine green staining from baseline to DAY 56 and DAY 70
Baseline to Day 70
Ocular Surface Parameters
Time Frame: Baseline to Day 70
Changes in anesthetic Schirmer's test from baseline to DAY 56 and DAY 70
Baseline to Day 70

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Chicago

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Eye Institute (NEI)
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ali R Djalilian, MD, University of Illinois at Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-1426
  • 3UH3EY031809-04S1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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