Efficacy of Locally Delivered Allogeneic Mesenchymal Stem Cells for Promoting Corneal Repair
University of Illinois at Chicago
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 fluoresce…
Interventions
- BiologicalMesenchymal 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.
- OtherControl Solution
For the control group, 150 µL of injectable normal saline (0.9% NaCl). will be injected.
Locations (4)
- Department of Ophthalmology and Visual SciencesChicago, Illinois
- University of Maryland at BaltimoreBaltimore, Maryland
- Mass Eye and Ear InfirmaryBoston, Massachusetts
- University of Pennsylvania, Scheie Eye InstitutePhiladelphia, Pennsylvania