At a glance
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Efficacy of Locally Delivered Allogeneic Mesenchymal Stem Cells for Promoting Corneal Repair
In Brief
A Phase 2 clinical trial evaluating Mesenchymal Stromal Cells and Control Solution for Corneal Ulcer. Currently recruiting, targeting 38 participants across 4 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.