Recruiting
Phase 2

Allogeneic MSCs

Sponsor:

University of Illinois at Chicago

Code:

NCT05705024

Conditions

Corneal Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mesenchymal Stromal Cells

Control Solution

Study Details

Brief 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). In the present study, we want to study the efficacy of this treatment on chronic epitheliopathies.

Conditions

Corneal Ulcer

Study ID

NCT05705024

Start date

Sep 29, 2023

Status verified date

Dec, 2025

Completion date

Sep 28, 2026

Anticipated

Primary completion date

Sep 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Visual Acuity:

  • 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.

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 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.

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.

Exclusion Criteria:

Visual Acuity:

  • 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 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.
  • 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

Study Design

Enrollment

38 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Medium dose of allogenic MSC drops

Dose of allogeneic MSC subconjunctival injection will be assigned 3,000,000 cells/150 µL.

sham comparator: Control Group

For the control group, 50 µL of the freezing media (vehicle) will be injected.

Interventions

Mesenchymal Stromal Cells

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 Solution

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

Primary outcome measure

  • Improvement of Corneal Epithelial Barrier and/or Integrity (Efficacy Rate) [ Time Frame: Day 28 ]

Central Contacts and Locations

Central contacts

Ali R Djalilian, MD

312-996-8937adjalili@uic.edu

Charlotte E Joslin, OD, PhD

312-996-5410charjosl@uic.edu

Locations

Department of Ophthalmology and Visual Sciences

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Ali R Djalilian, MD

312-996-8937adjalili@uic.edu

Charlotte E Joslin, OD, PhD

312-996-5410charjosl@uic.edu

University of Maryland at Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Sarah Sunshine, MD

ssunshine@som.umaryland.edu

Megan Utz

mutz@som.umaryland.edu

Principal Investigator:

Sarah Sunshine, MD

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2025-12-16.