The U.S. Food and Drug Administration granted expanded access for a regenerative therapy-based investigational product developed by an Austin-based Direct Biologics LLC called ExoFlo, a treatment for acute respiratory distress syndrome (ARDS) associated with SARS-CoV-2, the virus behind COVID-19.
TrialSite offers the network a brief breakdown of this regenerative therapeutic (e.g. stem cell)-based product.
What is ExoFlo?
An investigational new drug, it's an extracellular vesicle product isolated from human bone marrow mesenchymal stem or stromal cells (MSCs). ExoFlo provides natural bioactive signals that evidence the ability to modulate inflammation and direct cellular communication.
What does the expanded access protocol offer patients?
This makes ExoFlo available to a broader group of patients with severe COVID-19, many of them who would not meet acceptance criteria for EXIT COVID-19, often under conditions of “compassionate use.”
Why might the timing be good?
According to company co-founder Joe Schmidt this FDA action comes at an opportune time as new COVID-19 surges are coming due to the cold fall and winter seasons.
Is the investigational product inv...
Note: If you need assistance with your subscription or would like to discuss a corporate subscription for more than 10 employees please contact us or use the chat (bottom right).