Actively Recruiting
Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells
Led by University of Illinois at Chicago · Updated on 2025-12-16
38
Participants Needed
4
Research Sites
156 weeks
Total Duration
On this page
Sponsors
U
University of Illinois at Chicago
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Best corrected distance visual acuity (BCDVA) score 75 ETDRS letters or less (20/32 Snellen or worse) in the affected eye
- Non-resolving corneal epitheliopathy or epithelial defect after at least two weeks of standard non-surgical treatments
- No objective clinical improvement in the last two weeks (less than or equal to 50% reduction in fluorescein staining or epithelial defect size)
- If both eyes are affected, the worse eye will be treated
- Fluorescein staining score of 10 or higher by National Eye Institute grading indicating impaired epithelial barrier
- Patients with stage 1 to 3 neurotrophic keratopathy limited to 80% or less of corneal diameter
- Ability and willingness to comply with study procedures
- Signed informed consent form approved by the IRB
You will not qualify if you...
- Best corrected distance visual acuity better than 75 ETDRS letters (better than 20/32 Snellen) in the affected eye
- Ocular drug toxicity less than two weeks ago
- Any active ocular infection (bacterial, viral, fungal, protozoal) or active ocular inflammation in the affected eye
- Ocular surgery in the affected eye within three months before enrollment (except specific exceptions)
- Prior surgical procedures for chronic corneal epitheliopathy in the affected eye except amniotic membrane transplantation with specific timing restrictions
- Chronic corneal epitheliopathy with endothelial decompensation requiring corneal graft
- Anticipated need for punctual occlusion during the study treatment period
- Corneal ulcer involving the posterior third of the corneal stroma, corneal melting, or perforation
- Any ocular or systemic condition that might interfere with treatment efficacy or study evaluations
- Uncontrolled eyelid abnormalities or eyelash abnormalities preventing proper eyelid closure
- Known hypersensitivity to study or procedural medications
- History of drug, medication, or alcohol abuse
- Use of investigational agents within 4 weeks of screening
- Participation in another clinical study at the same time
- Pregnancy at study enrollment
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Department of Ophthalmology and Visual Sciences
Chicago, Illinois, United States, 60612
Actively Recruiting
2
University of Maryland at Baltimore
Baltimore, Maryland, United States, 21201
Actively Recruiting
3
Mass Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Active, Not Recruiting
4
University of Pennsylvania, Scheie Eye Institute
Philadelphia, Pennsylvania, United States, 19104
Active, Not Recruiting
Research Team
A
Ali R Djalilian, MD
CONTACT
C
Charlotte E Joslin, OD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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