Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT05705024
Phase
PHASE2
Status
Recruiting
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Conditions

  • Corneal Ulcer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mesenchymal Stromal Cells — BIOLOGICAL
    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
    For the control group, 150 µL of injectable normal saline (0.9% NaCl). will be injected.

Study Details

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.

Key Dates

Start date
Sep 29, 2023
Status verified
Dec 2025
Primary completion
Sep 28, 2026
Completion
Sep 28, 2026

Study Design

Enrollment
38 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Department of Ophthalmology and Visual SciencesChicagoIllinois60612
Ali R Djalilian, MD
[email protected]
312-996-8937
Charlotte E Joslin, OD, PhD
[email protected]
312-996-5410
University of Maryland at BaltimoreBaltimoreMaryland21201
Sarah Sunshine, MD
[email protected]
Megan Utz
[email protected]
Sarah Sunshine, MD (PRINCIPAL_INVESTIGATOR)
Mass Eye and Ear InfirmaryBostonMassachusetts02114-
University of Pennsylvania, Scheie Eye InstitutePhiladelphiaPennsylvania19104-

Find similar trials in Chicago, IL

By research site
Department of Ophthalmology and Visual Sciences· Chicago, ILUniversity of Maryland at Baltimore· Baltimore, MDMass Eye and Ear Infirmary· Boston, MAUniversity of Pennsylvania, Scheie Eye Institute· Philadelphia, PA

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