The mortality rate in SARS-CoV-2-related severe ARDS is high despite treatment with
antivirals, glucocorticoids, immunoglobulins, and ventilation. Preclinical and clinical
evidence indicate that MSCs migrate to the lung and respond to the pro-inflammatory lung
environment by releasing anti-inflammatory factors reducing the proliferation of
pro-inflammatory cytokines while modulating regulatory T cells and macrophages to promote
resolution of inflammation. Therefore, MSCs may have the potential to increase survival in
management of COVID-19 induced ARDS.
The primary objective of this phase 3 trial is to evaluate the efficacy and safety of the
addition of the mesenchymal stromal cell (MSC) remestemcel-L plus standard of care compared
to placebo plus standard of care in patients with acute respiratory distress syndrome (ARDS)
due to SARS-CoV-2. The secondary objective is to assess the impact of MSCs on inflammatory
biomarkers.
Phase:
Phase 3
Details
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborators:
Mesoblast, Inc. National Heart, Lung, and Blood Institute (NHLBI)