MSC Study for Corneal Ulcers
This study is looking at how well a treatment called Mesenchymal Stromal Cells (MSCs) works for people with corneal ulcers (sores on the clear front part of your eye) that haven't healed with standard treatments for at least two weeks. MSCs are special cells taken from bone marrow. You would receive a single injection of these cells under the conjunctiva (the clear membrane covering the white part of your eye), or a control solution (salt water). The study aims to see if this treatment can improve the healing of your cornea and your vision. It is open to adults aged 18 and older with certain vision levels in the affected eye. The study plans to include 38 participants.
- Study design
- This is a masked clinical trial, meaning neither you nor your doctor will know if you receive the MSCs or the control solution. It plans to enroll 38 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your corneal healing will be measured at Day 28 after the injection.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05705024
Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of Illinois at ChicagoInvestigator-initiated
~38 participants
Updated 2025-12-16 on ClinicalTrials.gov
What's tested:Mesenchymal Stromal CellsControl Solution
At a glance
Recruiting sites
2 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Improvement of Corneal Epithelial Barrier and/or Integrity (Efficacy Rate)
Measured over Day 28
Conditions
Where it's being run
4 sites across 4 statesIllinois1
Maryland1
Massachusetts1
Pennsylvania1
Study leadership
- Ali R Djalilian, MD · PRINCIPAL_INVESTIGATOR · University of Illinois at Chicago
- Charlotte E Joslin, OD, PhD · PRINCIPAL_INVESTIGATOR · University of Illinois at Chicago
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Best corrected distance visual acuity (BCDVA) score ≤ 75 ETDRS letters, (≥ 0.2 LogMAR, ≤ 20/32 Snellen or ≤ 0.625 decimal fraction) in the affected eye.
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 10 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.
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.
Exclusion
Best-corrected distance visual acuity (BCDVA) score better than 75 ETDRS letters, or 0.2 LogMAR, or 20/32 Snellen or 0.625 decimal fraction in the affected eye
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.
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
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
What this trial measures
- Improvement of Corneal Epithelial Barrier and/or Integrity (Efficacy Rate)Day 28
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