MSCs in COVID-19 ARDS

Inclusion Criteria - 18 years or older - Patient has SARS-CoV-2 (COVID-19) confirmed by real-time reverse transcription polymerase chain reaction (RT-PCR) assay or other diagnostic test - Patient requiring mechanical ventilatory support with moderate to severe ARDS as determined by the following criteria (adapted from the Berlin criteria) - Bilateral opacities must be present on a chest radiograph or computerized tomographic (CT) scan. These opacities are not fully explained by pleural effusions, lobar collapse, lung collapse, or pulmonary nodules. - Respiratory failure not fully explained by cardiac failure or fluid overload. - Moderate to severe impairment of oxygenation must be present, as defined by the ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2). The severity of the hypoxemia defines the severity of the ARDS: - Moderate ARDS: PaO2/FiO2 >100 mmHg and ≤200 mmHg, on ventilator settings that include PEEP ≥5 cm H2O OR - Severe ARDS: PaO2/FiO2 ≤100 mmHg on ventilator settings that include PEEP ≥5 cm H2O - High sensitivity C-Reactive Protein (hs-CRP) or CRP serum level >4.0 mg/dL - Acute Physiologic and Chronic Health Evaluation (APACHE IV) score >5 - Creatinine clearance of ≥ 30 mL/minute OR a creatinine clearance of 20-29 mL/minute with urine output of ≥0.3 mLs/kg/hour over the last 8 hours or ≥500 mLs over the last 24 hours - The patient or his/her legally authorized representative (LAR) is able to provide informed consent

Exclusion Criteria - Currently receiving extracorporeal membrane oxygenation (ECMO) or high frequency oscillatory ventilation (HFOV) - Females who are pregnant or lactating - Patients with established positive bacterial blood cultures prior to enrollment or suspicion of superimposed bacterial pneumonia - Patients with BMI >55 - Patients with untreated HIV infection - Patients with malignancy who are within 12 months of active treatment with any chemotherapy, radiation or immunotherapy. - Patients who have been intubated for more than 72 hours in total at the time of randomization - Creatinine clearance less than 20 mL/minute or receiving renal replacement therapy - LFTs (isolated ALT or AST) > 8x upper limit of normal or > 5x upper limit of normal in the setting of other liver function abnormalities (i.e., total bilirubin ≥ 2x upper limit of normal) - Known hypersensitivity to DMSO or to porcine or bovine proteins - History of prior respiratory disease with requirement for supplemental oxygen - Any end-stage organ disease which in the opinion of the investigator may possibly affect the safety of remestemcel-L treatment - Receiving an investigational cellular therapy agent