A Phase 2 interventional study of Mesenchymal Stromal Cells and Control Solution in Corneal Ulcer, sponsored by University of Illinois Chicago. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by University of Illinois Chicago · Phase 2, Interventional, and Treatment
The proposed Conventional Cohort Expansion Study involves the use of Mesenchymal Stromal Cells (MSCs) are derived from the bone marrow. We previously studied the safety of subconjunctival injection of allogeneic bone marrow-derived MSCs in patients with nonhealing epitheliopathy (IRB Protocol 2020-0334). In the present study, we want to study the efficacy of this treatment on chronic epitheliopathies.
The "Efficacy of Locally Delivered Allogeneic Mesenchymal Stem Cells for Promoting Corneal Repair Study" otherwise known as the "MSC Study," is designed to assess the safety of allogeneic bone marrow-derived MSC secreted factor on the ocular surface via subconjunctival injection of MSC, and also obtain a preliminary observation on the following:
The objective is to improve clinical outcomes in significant non-healing corneal wounds. To achieve these goals, the MSC Study will include a Phase II efficacy study.
63 studies on the registry are indexed under Corneal Ulcer; 8 are open to participants now.
This study's planned enrollment of 38 is below the median of 60 across 45 interventional studies indexed under Corneal Ulcer.
Browse Corneal Ulcer studies →University of Illinois Chicago is the lead sponsor of 20 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 4, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Ocular Health:
Study Procedures:
Exclusion Criteria:
Visual Acuity:
Ocular Health:
Study Procedures:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose of allogeneic MSC subconjunctival injection will be assigned 3,000,000 cells/150 µL.
Biological: Mesenchymal Stromal Cells
For the control group, 50 µL of the freezing media (vehicle) will be injected.
Other: Control Solution
Subconjunctival Injection of Allogeneic Mesenchymal Stromal Cellsmasked clinical trial, patients with non-resolving corneal epithelial disease (i.e., refractory to standard treatments for at least two weeks) will receive a single subconjunctival injection of bone marrow-derived allogeneic MSCs or vehicle (CS5 freezing media, BioLife Solutions Inc, Bothell, WA, USA), with continued follow-up for up to 90 days.
For the control group, 150 µL of injectable normal saline (0.9% NaCl). will be injected.
Improvement of Corneal Epithelial Barrier and/or Integrity (Efficacy Rate)
The proportion of patients with improved epithelial barrier and/or integrity from baseline to DAY 28 as determined by the investigator on slit lamp examination: * Improved epithelial barrier, defined as a 50 % improvement in corneal fluorescein staining score * Improved epithelial integrity, defined as a healed epithelial defect
Time frame: Day 28
Visual Acuity
Percent change in best-corrected distance visual acuity from baseline to DAY 90, as measured using standard ETDRS protocols
Time frame: Baseline, Days 1-7, 28, 60, 90
Corneal staining and NEI grading
Grading of fluorescein staining of the cornea
Time frame: Baseline, Days 1-7, 28, 60, 90
Ocular Surface Parameters
Changes in tear breakup time (TBUT), ocular surface disease index (OSDI), Lissamine green staining, and anesthetic Schirmer's test from baseline to DAY 28 and DAY 90
Time frame: Baseline, Day 28, 90
Corneal Epithelial Thickness
Percent change in corneal epithelial thickness from baseline to DAY 28 and DAY 90, as measured by anterior segment OCT (AS-OCT)
Time frame: Day 28, 90
Patient 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 90
Time frame: Baseline, Days 1-7, 28, 60, 90
Time to epithelial healing
Time of improvement of epitheliopathy
Time frame: Baseline, Days 1-7, 28, 60, 90
Corneal Scar
Change in the size of corneal scar (if present) from baseline to DAY 90, as documented by slit lamp photographs
Time frame: Baseline, Days 1-7, 28, 60, 90
Corneal Neo-vascularization
Change in corneal vascularization on slit lamp photographs from baseline to DAY 90
Time frame: Baseline, Days 1-7, 28, 60, 90
Conjunctival injection
Change in conjunctival injection on slit lamp examination from baseline to DAY 90
Time frame: Baseline, Days 1-7, 28, 60, 90
Not enrolling at this site.
Not enrolling at this site.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Illinois Chicago