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Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells

NCT05705024 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-12-16

No results posted yet for this study

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.

Conditions

  • Corneal Ulcer

Interventions

BIOLOGICAL

Mesenchymal 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.

OTHER

Control Solution

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

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Ali R Djalilian, MD · University of Illinois at Chicago

  • Charlotte E Joslin, OD, PhD · University of Illinois at Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-29
Primary Completion
2026-09-28
Completion
2026-09-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05705024 on ClinicalTrials.gov