September 28, 2020 -- Stemedica Cell Technologies received investigational new drug (IND) approval from the U.S. Food and Drug Administration (FDA) for intravenous allogeneic mesenchymal stem cells (MSCs) in the treatment of moderate to severe COVID-19.
A new clinical study will enroll up to 40 patients in two cohorts in a randomized design where patients will receive either the drug or placebo plus standard treatment. The cell therapy is attractive for the treatment of severe lung injury due to COVID-19 because of its low immunogenicity and immunomodulatory effects.
Prior to submission of an IND, patients were treated with stem cells on emergency use and expanded use INDs at Providence Saint John's Health Center (Santa Monica, CA) and ProMedica (Toledo, OH). Within 24 to 48 hours of treatment, all patients had improved clinical symptoms. As well, 88% of these patients also had a significant reduction in acute-phase reactants, which reduced cytokine storms.
The stem cells were developed using Stemedica's proprietary manufacturing technology platform, which produces allogenic progenitor cell products under a low-oxygen, low-tension environment in a current good manufacturing practice-compliant manufacturing facility.
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