NCT05705024

Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells

Efficacy of Locally Delivered Allogeneic Mesenchymal Stem Cells for Promoting Corneal Repair

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 II efficacy study.

Conditions

• Corneal Ulcer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-29
• Primary completion: 2026-09-28
• Completion: 2026-09-28
• First posted: 2023-01-30
• Last updated: 2025-12-16

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study