Mesenchymal stromal cell (MSC) therapy for COVID-19 pneumonia

The cytokine storm, resulting from the extreme immune response to COVID-19 virus, has been identified as the key event that leads to the acute respiratory distress and multiple organ damage, eventually leading to death in COVID-19 infection. The cell therapy, mesenchymal stromal cells (MSC), secrete anti-inflammatory factors that can prevent the cytokine storm. The first published report of 7 patients with severe COVID-19 pneumonia showed that MSC therapy was able to change the inflammatory status of severely ill patients and significantly improve pulmonary function. The small study demonstrated that MSC therapy was safe and effective in severe COVID-19 pneumonia. Our centre manufactures an allogeneic MSC product, under licence from Isopogen Pty Ltd, that is cryopreserved for off-the-shelf use. No donor matching is required and the MSC have natural immunity to COVID-19. The objective of this study is to identify and treat deteriorating COVID-19 patients with MSC therapy to attenuate the cytokine storm response to the COVID-19 virus and thus prevent acute respiratory distress and multi organ damage, improving chance of survival. This is an open label trial, planned to recruit and consent 10 high risk patients on admission. Patients will receive MSC infusions if they are COVID-19 positive and have increasing oxygen requirements to maintain O2 sat of >92%. The primary study endpoint is safety, with secondary endpoints of clinical parameter assessment, including oxygen requirements, ventilatory support, ICU admission, length of stay, survival and the effect of treatment on inflammatory markers.