Ventilator-dependent COVID-19 patients with moderate/severe acute respiratory distress syndrome (ARDS) who were treated with intravenous infusions of an allogeneic mesenchymal stem cell product candidate had a survival rate of 83%.

The allogeneic mesenchymal stem cell product candidate remestemcel-L from Mesoblast Limited (Melbourne, Australia) was administered within the first five days under emergency compassionate use at New York Citys Mt Sinai hospital during the period March-April 2020. Patients received a variety of experimental agents prior to remestemcel-L. All patients were treated under an emergency Investigational New Drug (IND) application or expanded access protocol at Mt Sinai hospital. 75% of the patents successfully came off ventilator support within a median of 10 days, in contrast to only 9% of ventilator-dependent COVID-19 patients being able to come off ventilators with standard of care treatment and only 12% survival in ventilator-dependent COVID-19 patients at two major referral hospital networks in New York during the same time period. These poor outcomes are consistent with earlier published data from China where mortality rates of over 80% were reported in patients with COVID-19 and moderate/severe ARDS.

The remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent in cytokine release syndromes associated with high mortality, including acute graft versus host disease and COVID-19 ARDS, said Mesoblast Chief Executive Dr. Silviu Itescu. We intend to rapidly complete the randomized, placebo-controlled Phase 2/3 trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients.

There is a significant need to improve the dismal survival outcomes in COVID-19 patients who progress to ARDS and require ventilators, said Mesoblast Chief Medical Officer Dr Fred Grossman. We have implemented robust statistical analyses in our Phase 2/3 trial as recommended by the US Food and Drug Administration (FDA) in order to maximize our ability to evaluate whether remestemcel-L provides a survival benefit in moderate/severe COVID-19 ARDS.

Related Links:Mesoblast Limited

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Stem Cell Therapy Shows 83% Survival in COVID-19 Patients Dependent on Ventilator - HospiMedica