Cord Blood-Derived Mesenchymal Stem Cells for the Treatment of Moderate, Severe or Critical Pneumonia

Inclusion Criteria

• Age greater than or equal 18 years
• Patients with chest x-ray findings concerning for pneumonia from any cause, with clinical signs suggestive of at least moderate illness such as respiratory rate > 20 breaths per minute or with oxygen saturation less than 93% on room air * Definitions of pneumonia: * Moderate: chest X-ray (CXR) findings concerning for pneumonia and respiratory rate > 20 breaths per minute OR saturation of oxygen < 93% on room air * Severe: CXR findings concerning for pneumonia and respiratory rate > 30 breaths per minute or saturation of peripheral oxygen (SpO2) < 93% or partial pressure of oxygen in arterial blood/fraction of inspiratory oxygen concentration (PaO2/FiO2) < 300 * Critical: CXR findings concerning for pneumonia and requiring endotracheal intubation and mechanical ventilation OR oxygen delivered by high flow nasal cannula at flow rates > 20L/min with fraction of delivered oxygen > 0.5 OR noninvasive positive pressure ventilation OR extracorporeal membrane oxygenation (ECMO) * Of note patients may also have signs and symptoms of severe or critical illness such as PaO2/FiO2 < 300, but only need to meet criteria for moderate disease as defined above in order to be eligible for study
• Patients with coronavirus (COVID)-19 associated pneumonia must meet baseline categorization of moderate, severe or critical COVID-19 per Food and Drug Administration (FDA) Guidance for Industry COVID-19: Developing Drugs and Biologics Products for Treatment or Prevention, February 2021
• Negative pregnancy test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
• Patient or legally authorized representative consent. Patients with diminished mental capacity may be allowed on to enroll on the study
• Because of the nature of COVID-19, patients enrolled on this study with COVID-19 associated pneumonia may have been previously enrolled in other Investigational New Drug (IND) trials for their cancer diagnosis or COVID-19. These enrollments will not exclude them from enrollment to this study

Exclusion Criteria

• Moribund patients not expected to survive up to 48 hours
• Patients with severe chronic liver disease (Childs-Pugh score > 10)
• Pregnant and/or lactating women
• Patients on extracorporeal membrane oxygenation