Mesenchymal Stromal Cell Therapy For Acute Respiratory Distress Syndrome Due To Covid-19

Abstract

The acute respiratory distress syndrome (ARDS) resulting from coronavirus disease 2019 (COVID-19) is associated with a massive release of inflammatory cytokines and high mortality. Mesenchymal stromal cells (MSCs) have anti-inflammatory properties and have shown activity in treating acute lung injury. Here, we report a case series of 11 patients with COVID-19-associated ARDS (CARDS), requiring mechanical ventilation, who were treated with remestemcel-L, an allogeneic MSC product, under individual patient emergency investigational new drug (eIND) applications. Patients were eligible if they were mechanically ventilated for less than 72 hours prior to the first infusion. Patients with pre-existing lung disease requiring supplemental oxygen or severe liver or kidney injury were excluded. Each patient received two infusions of remestemcel-L at a dose of 2 million cells/kg/infusion, 48-120 hours apart. Remestemcel-L infusions were well-tolerated in all eleven patients. At the end of the 28-days follow-up period 10 patients (91%, 95% confidence interval [CI]; 59-100%) were extubated, 9 patients (82%, 95% CI; 48-97%) remained liberated from mechanical ventilation and were discharged from the ICU and two (18%, 95 CI%; 2-52%) died. The median time to extubation was ten days. 8 patients (73%, 95% CI; 34-100%) were discharged from the hospital. C-reactive protein levels significantly declined within five days of MSC infusion. In summary, we demonstrate that in this case series remestemcel-L infusions to treat moderate to severe CARDS were safe, well-tolerated and resulted in improved clinical outcome.