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Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells

ConditionCorneal Ulcer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mesenchymal Stromal Cells

    Biological/Vaccine

    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

    Other intervention

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

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Medium dose of allogenic MSC dropsActive comparator 1 intervention
Group B: Control GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Corneal staining and NEI grading

Grading of fluorescein staining of the cornea

Time frame
Baseline, Days 1-7, 28, 60, 90
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Illinois at Chicago

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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