Mesoblast Limited presented clinical outcomes from the randomized controlled trial of remestemcel-L in ventilator-dependent COVID-19 patients with moderate/severe acute respiratory distress syndrome (ARDS). Results of respiratory function were highlighted at the biennial Stem Cells, Cell Therapies, and Bioengineering in Lung Biology and Diseases conference hosted by the University of Vermont, Burlington, VT, on July 15. The trial in mechanically ventilated COVID-19 patients with moderate/severe ARDS enrolled 222 patients across the United States, of whom 217 were randomized 1:1 and received either standard of care alone or standard of care plus 2 intravenous infusions of remestemcel-L at a dose of 2 million cells/kg 3-5 days apart. As previously announced, while the trial did not meet its endpoint of 43% reduction in overall mortality, mortality was reduced through 60 days in the pre-specified subgroup analysis of 123 patients younger than 65, but not in those older than 65 where a more exuberant inflammatory response due to defective immune-mediated viral clearance mechanisms may require more prolonged or higher dosing of anti-inflammatory therapy. The mortality benefit in patients under 65 was even greater when remestemcel-L was used in addition to dexamethasone as standard of care. Key secondary outcome results that were presented included: In patients under 65 years old, remestemcel-L improved respiratory function, as defined in pre-specified analyses by resolution or improvement in ARDS using the Berlin Criteria, at each of days 7, 14, 21, and 30 post-randomization, with Odds Ratio (OR) at Day 30 relative to controls of 2.2, 95% CI (1.0, 4.7). In patients older than 65 years old, remestemcel-L improved respiratory function at day 7 relative to controls, but not at later time points, supporting the conclusion that more prolonged or higher dosing may be warranted in those over age 65 with COVID-19 ARDS. Remestemcel-L improved respiratory function to an even greater extent in patients under 65 who received dexamethasone as part of their standard of care at each of days 7, 14, 21, and 30 post-randomization, with OR at Day 30 relative to controls on Dexamethasone alone of 3.6, 95% CI (1.2, 10.7). Remestemcel-L also improved clinical outcomes based on a 7-point ordinal scale in patients under 65 who received dexamethasone as part of their standard of care at each of days 7, 14, 21, and 30 post-randomization, with OR at Day 30 relative to controls on Dexamethasone alone of 2.9, 95% CI (1.1, 7.7).