Ann: Remestemcel-L FDA Fast Track Designation for COVID-19 ARDS, page-570

Texas Heart Institute (THI) has been selected as one of up to 60 sites in the world to participate in an international investigative study seeking to aid COVID-19 patients who develop acute respiratory distress syndrome (ARDS). Dr. Emerson Perin, a globally recognized cardiologist known for his work developing stem cell therapies for cardiovascular diseases, is serving as the study's principal investigator at Texas Heart Institute.

Sponsored by the Australian regenerative medicine company Mesoblast, the study will commence locally through the Cardiothoracic Surgical Trials Network at Texas Heart Institute in December 2020. As part of the study - which will focus on the sickest of patients - participating ICU patients with ARDS due to COVID-19 will be randomized to receive intravenous infusions of allogeneic mesenchymal stromal cell-based therapy or placebo in addition to maximal care. According to the CDC, as many as 85% of ICU patients suffer from ARDS, and 20 to 42% of patients hospitalized with COVID-19 develop the complication. Over 40% of ICU patients diagnosed with ARDS die - with some studies indicating a number as high as 72% - and those who survive the complication spend 10-13 days in the hospital on average..

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The Texas Heart Institute will now utilize the treatment as part of the continuing global study, and Dr. Perin is optimistic that promising results will persist. "It is very important to have options for patients who are running out of lifelines in the fight against COVID-19. Individuals have responded well to this treatment, and Texas Heart Institute is poised to help save lives of those who are running out of hope," he concluded.

What do you think people? Is this a bit of an "up yours" to the FDA and a nudge to them to "get on board"?