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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
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.
For the control group, 150 µL of injectable normal saline (0.9% NaCl). will be injected.
Department of Ophthalmology and Visual Sciences
Chicago, Illinois, United States
RECRUITINGUniversity of Maryland at Baltimore
Baltimore, Maryland, United States
RECRUITINGMass Eye and Ear Infirmary
Boston, Massachusetts, United States
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
Time frame: Day 28
Visual Acuity
Percent change in best-corrected distance visual acuity from baseline to DAY 90, as measured using standard ETDRS protocols
Time frame: Baseline, Days 1-7, 28, 60, 90
Corneal staining and NEI grading
Grading of fluorescein staining of the cornea
Time frame: Baseline, Days 1-7, 28, 60, 90
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
Time frame: Baseline, Day 28, 90
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)
Time frame: Day 28, 90
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
Time frame: Baseline, Days 1-7, 28, 60, 90
Time to epithelial healing
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University of Pennsylvania, Scheie Eye Institute
Philadelphia, Pennsylvania, United States
ACTIVE_NOT_RECRUITINGTime of improvement of epitheliopathy
Time frame: Baseline, Days 1-7, 28, 60, 90
Corneal Scar
Change in the size of corneal scar (if present) from baseline to DAY 90, as documented by slit lamp photographs
Time frame: Baseline, Days 1-7, 28, 60, 90
Corneal Neo-vascularization
Change in corneal vascularization on slit lamp photographs from baseline to DAY 90
Time frame: Baseline, Days 1-7, 28, 60, 90
Conjunctival injection
Change in conjunctival injection on slit lamp examination from baseline to DAY 90
Time frame: Baseline, Days 1-7, 28, 60, 90