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Corneal UlcerPhase 2NCT05705024

Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells

A Phase 2 study testing Mesenchymal Stromal Cells in people with Corneal Ulcer, run by University of Illinois Chicago at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Corneal Ulcer
What is being tested?
Mesenchymal Stromal Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
4 sitesUnited States
Study dates
29 Sep 2023to 28 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

  • Ocular Health:
  • Patients with non-resolving corneal epitheliopathy or epithelial defect after two or more weeks of standard non-surgical treatments (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops; anti-inflammatory therapy, soft bandage contact lens).
  • No objective clinical evidence of improvement in the last 2 weeks (≤50% reduction in fluorescein staining or ≤50% reduction in longest diameter of the epithelial defect).
  • If both eyes have chronic epithelial disease, the eye with the worse epithelial disease will be treated.
  • Evidence of impaired epithelial barrier manifested by fluorescein staining of the epithelium with a score 6 or higher by National Eye Institute grading.
  • Patients with stage 1 (no epithelial defect), stage 2 (persistent epithelial defect, PED; without stromal loss) or stage 3 (corneal ulcer; with stromal loss) neurotrophic keratopathy25-27 limited to ≤80% corneal diameter.
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  • 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 representatives must have been approved by the IRB for the current study.
  • Patients must have the ability and willingness to comply with study procedures.

Who cannot join

  • Visual Acuity:
  • Ocular Health:
  • Ocular drug toxicity less than two weeks ago
  • Any active ocular infection (bacterial, viral, fungal or protozoal) or active ocular inflammation in the affected eye.
  • History of any ocular surgery (including laser or refractive surgical procedures) in the affected eye within the three months before study enrollment. (An exception to the preceding statement will be allowed if the ocular surgery is considered to be the cause of the PED. Ocular surgery in the affected eye will not be allowed during the study treatment period and elective ocular surgery procedures should not be planned during the duration of the follow-up period unless the patient will be involved in corneal thinning of more than 1/3 corneal stroma, corneal melting or perforation.
  • Prior surgical procedure(s) for the treatment of a chronic corneal epitheliopathy (e.g., complete tarsorrhaphy, conjunctival flap, etc.) in the affected eye with the exception of amniotic membrane transplantation. Patients previously treated with amniotic membrane transplantation may only be enrolled two weeks after the membrane has disappeared within the area of the chronic corneal epitheliopathy or corneal ulcer or at least six weeks after the date of the amniotic membrane transplantation procedure. Patients previously treated with Botox (botulinum toxin) injections used to induce pharmacologic blepharoptosis are eligible for enrollment only if the last injection was given at least 90 days prior to enrollment in the study.
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  • Chronic corneal epitheliopathy in the background of endothelial decompensation that needs corneal graft
  • Anticipated need for punctual occlusion during the study treatment period. Patients with punctual occlusion or punctual plugs inserted prior to the study are eligible for enrollment provided that the punctual occlusion is maintained during the study.
  • Evidence of corneal ulceration involving the posterior third of the corneal stroma, corneal melting or perforation in the affected eye.
  • Presence or history of any ocular or systemic disorder or condition that might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct (e.g., progressive or degenerative corneal or retinal conditions, uveitis, optic neuritis, poorly controlled diabetes, autoimmune disease, systemic infection, neoplastic diseases).
  • Patients with uncontrolled eyelid abnormality that preclude appropriate eyelid closure or including eyelash abnormality
  • Study Procedures:
  • Known hypersensitivity to one of the components of the study or procedural medications (e.g., fluorescein).
  • History of drug, medication or alcohol abuse or addiction.
  • 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 will be excluded; pregnancy is identified according to the patient's self-report /positive βhCG

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ali R Djalilian, MD contact

312-996-8937

adjalili@uic.edu

Charlotte E Joslin, OD, PhD contact

312-996-5410

charjosl@uic.edu

United States4 sites, 2 recruiting

  • University of Maryland at Baltimore

    Baltimore, Maryland, 21201

    Sarah Sunshine, MD, ssunshine@som.umaryland.edu

    Megan Utz, mutz@som.umaryland.edu

    Recruiting

  • Mass Eye and Ear Infirmary

    Boston, Massachusetts, 02114

    Active, not recruiting

  • Department of Ophthalmology and Visual Sciences

    Chicago, Illinois, 60612

    Ali R Djalilian, MD, 312-996-8937, adjalili@uic.edu

    Charlotte E Joslin, OD, PhD, 312-996-5410, charjosl@uic.edu

    Recruiting

  • University of Pennsylvania, Scheie Eye Institute

    Philadelphia, Pennsylvania, 19104

    Active, not recruiting

Other trials in United States

About this study

Official title: Efficacy of Locally Delivered Allogeneic Mesenchymal Stem Cells for Promoting Corneal Repair

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.

Read the detailed description

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:

  • Epithelial barrier integrity and/or wound closure.
  • Development of Scarring.
  • Final Visual Acuity.

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.

Conditions
Corneal Ulcer
Being tested
Mesenchymal Stromal Cells, Control Solution
Medical subject headings
Corneal Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mesenchymal Stromal CellsBiological

    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.

  • Control SolutionOther

    For the control group, 150 µL of injectable normal saline (0.9% NaCl). will be injected.

Study groups in NCT05705024
Study groupRoleWhat they receive
Medium dose of allogenic MSC dropsActive comparatorDose of allogeneic MSC subconjunctival injection will be assigned 3,000,000 cells/150 µL.
Receives: Biological: Mesenchymal Stromal Cells
Control GroupSham comparatorFor the control group, 50 µL of the freezing media (vehicle) will be injected.
Receives: Other: Control Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 28

Secondary outcomes (9)

  1. Visual Acuity

    Percent change in best-corrected distance visual acuity from baseline to DAY 90, as measured using standard ETDRS protocols

    Measured: Baseline, Days 1-7, 28, 60, 90

  2. Corneal staining and NEI grading

    Grading of fluorescein staining of the cornea

    Measured: Baseline, Days 1-7, 28, 60, 90

  3. 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

    Measured: Baseline, Day 28, 90

  4. 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)

    Measured: Day 28, 90

  5. 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

    Measured: Baseline, Days 1-7, 28, 60, 90

  6. Time to epithelial healing

    Time of improvement of epitheliopathy

    Measured: Baseline, Days 1-7, 28, 60, 90

  7. Corneal Scar

    Change in the size of corneal scar (if present) from baseline to DAY 90, as documented by slit lamp photographs

    Measured: Baseline, Days 1-7, 28, 60, 90

  8. Corneal Neo-vascularization

    Change in corneal vascularization on slit lamp photographs from baseline to DAY 90

    Measured: Baseline, Days 1-7, 28, 60, 90

  9. Conjunctival injection

    Change in conjunctival injection on slit lamp examination from baseline to DAY 90

    Measured: Baseline, Days 1-7, 28, 60, 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2023
  2. Study start29 Sep 2023
  3. Primary completion28 Dec 2026 (estimated)
  4. Study completion28 Dec 2026 (estimated)

Resources

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, Care provider
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05705024
Sponsor's protocol ID
2022-0751
Other IDs
W81XWH-18-1-0661
Status last verified
Dec 2025
First submitted
21 Jan 2023
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cockerham GC, Lemke S, Rice TA, Wang G, Glynn-Milley C, Zumhagen L, Cockerham KP. Closed-globe injuries of the ocular surface associated with combat blast exposure. Ophthalmology. 2014 Nov;121(11):2165-72. doi: 10.1016/j.ophtha.2014.06.009. Epub 2014 Aug 11.

    PubMed 25124272

  • Cockerham GC, Lemke S, Glynn-Milley C, Zumhagen L, Cockerham KP. Visual performance and the ocular surface in traumatic brain injury. Ocul Surf. 2013 Jan;11(1):25-34. doi: 10.1016/j.jtos.2012.09.004. Epub 2012 Oct 5.

    PubMed 23321357

  • Cockerham GC, Rice TA, Hewes EH, Cockerham KP, Lemke S, Wang G, Lin RC, Glynn-Milley C, Zumhagen L. Closed-eye ocular injuries in the Iraq and Afghanistan wars. N Engl J Med. 2011 Jun 2;364(22):2172-3. doi: 10.1056/NEJMc1010683. No abstract available.

    PubMed 21631351

  • Baradaran-Rafii A, Eslani M, Tseng SC. Sulfur mustard-induced ocular surface disorders. Ocul Surf. 2011 Jul;9(3):163-78. doi: 10.1016/s1542-0124(11)70026-x.

    PubMed 21791191

  • Prockop DJ, Oh JY. Mesenchymal stem/stromal cells (MSCs): role as guardians of inflammation. Mol Ther. 2012 Jan;20(1):14-20. doi: 10.1038/mt.2011.211. Epub 2011 Oct 18.

    PubMed 22008910

  • Mittal SK, Omoto M, Amouzegar A, Sahu A, Rezazadeh A, Katikireddy KR, Shah DI, Sahu SK, Chauhan SK. Restoration of Corneal Transparency by Mesenchymal Stem Cells. Stem Cell Reports. 2016 Oct 11;7(4):583-590. doi: 10.1016/j.stemcr.2016.09.001. Epub 2016 Sep 29.

    PubMed 27693426

  • Wang LT, Ting CH, Yen ML, Liu KJ, Sytwu HK, Wu KK, Yen BL. Human mesenchymal stem cells (MSCs) for treatment towards immune- and inflammation-mediated diseases: review of current clinical trials. J Biomed Sci. 2016 Nov 4;23(1):76. doi: 10.1186/s12929-016-0289-5.

    PubMed 27809910

  • Yun YI, Park SY, Lee HJ, Ko JH, Kim MK, Wee WR, Reger RL, Gregory CA, Choi H, Fulcher SF, Prockop DJ, Oh JY. Comparison of the anti-inflammatory effects of induced pluripotent stem cell-derived and bone marrow-derived mesenchymal stromal cells in a murine model of corneal injury. Cytotherapy. 2017 Jan;19(1):28-35. doi: 10.1016/j.jcyt.2016.10.007. Epub 2016 Nov 10.

    PubMed 27840134

  • Ye J, Yao K, Kim JC. Mesenchymal stem cell transplantation in a rabbit corneal alkali burn model: engraftment and involvement in wound healing. Eye (Lond). 2006 Apr;20(4):482-90. doi: 10.1038/sj.eye.6701913.

    PubMed 15895027

  • Yao L, Li ZR, Su WR, Li YP, Lin ML, Zhang WX, Liu Y, Wan Q, Liang D. Role of mesenchymal stem cells on cornea wound healing induced by acute alkali burn. PLoS One. 2012;7(2):e30842. doi: 10.1371/journal.pone.0030842. Epub 2012 Feb 17.

    PubMed 22363499

  • Roddy GW, Oh JY, Lee RH, Bartosh TJ, Ylostalo J, Coble K, Rosa RH Jr, Prockop DJ. Action at a distance: systemically administered adult stem/progenitor cells (MSCs) reduce inflammatory damage to the cornea without engraftment and primarily by secretion of TNF-alpha stimulated gene/protein 6. Stem Cells. 2011 Oct;29(10):1572-9. doi: 10.1002/stem.708.

    PubMed 21837654

  • Oh JY, Kim MK, Shin MS, Lee HJ, Ko JH, Wee WR, Lee JH. The anti-inflammatory and anti-angiogenic role of mesenchymal stem cells in corneal wound healing following chemical injury. Stem Cells. 2008 Apr;26(4):1047-55. doi: 10.1634/stemcells.2007-0737. Epub 2008 Jan 10.

    PubMed 18192235

  • Ma Y, Xu Y, Xiao Z, Yang W, Zhang C, Song E, Du Y, Li L. Reconstruction of chemically burned rat corneal surface by bone marrow-derived human mesenchymal stem cells. Stem Cells. 2006 Feb;24(2):315-21. doi: 10.1634/stemcells.2005-0046. Epub 2005 Aug 18.

    PubMed 16109757

  • Li F, Zhao SZ. Control of Cross Talk between Angiogenesis and Inflammation by Mesenchymal Stem Cells for the Treatment of Ocular Surface Diseases. Stem Cells Int. 2016;2016:7961816. doi: 10.1155/2016/7961816. Epub 2016 Mar 24.

    PubMed 27110252

  • Cejkova J, Trosan P, Cejka C, Lencova A, Zajicova A, Javorkova E, Kubinova S, Sykova E, Holan V. Suppression of alkali-induced oxidative injury in the cornea by mesenchymal stem cells growing on nanofiber scaffolds and transferred onto the damaged corneal surface. Exp Eye Res. 2013 Nov;116:312-23. doi: 10.1016/j.exer.2013.10.002. Epub 2013 Oct 18.

    PubMed 24145108

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mesenchymal Stromal Cells in people with Corneal Ulcer, run by University of Illinois Chicago at 4 sites 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 9 inclusion and 17 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 (312-996-8937, 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 Rate) (time frame: Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05705024, which also lists 29 linked publications.

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 4 Nov 2026.

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