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

PRIMARY OBJECTIVE:

• To assess the safety of administering cord blood derived mesenchymal stem cell (CB-MSC) infusions for treatment of moderate, severe or critical pneumonia.

SECONDARY OBJECTIVES:

• In the group of participants who present intubated on ventilator support, assess the proportion that are able to be successfully extubated.
• In the group of participants who present requiring supplemental oxygen but otherwise breathing without assistance, assess the rate of progression to intubation.
• Estimate the survival rate at day 30 post treatment separately by group.
• Determine the treatment effect on clinical parameters, oxygenation and respiratory parameters:

• Resolution of fever
• Changes in oxygen demand (increased oxygen saturation at similar FiO2 or decreased FiO2 requirement)
• Progression to mechanical ventilation
• Length of Mechanical ventilation
• Decrease in PEEP in intubated participants
• Decrease in FiO2 in intubated participants
• Determine the treatment effect on laboratory markers:

• Complete blood count
• CRP
• Ferritin
• D Dimer
• Procalcitonin
• Cytokine levels
• Estimate hospitalization and ICU stay.
• Report on study related adverse events.

OUTLINE:

Currently not shipping cells outside of MD Anderson Cancer Center in Houston.

PILOT STUDY: Patients receive MSCs intravenously (IV) over 1-2 hours on day 1. participants may receive a second infusion of MSCs within 7 days after the first infusion per physician discretion.

PHASE II STUDY: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive MSCs IV over 1-2 hours on day 1. Patients may receive a second infusion of MSCs within 7 days after the first infusion per physician discretion.

ARM II: Patients receive standard of care.

After completion of study treatment, patients are followed up at days 7, 14, 30, 60, and months 6 and 12.

Inclusion criteria

• Age greater than or equal 18 years.
• Participants 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**
• Participants with COVID-19 associated pneumonia must meet baseline categorization of Moderate, Severe or Critical COVID-19 per 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.
• Participant or legally authorized representative consent. Participants with diminished mental capacity may be allowed on to enroll on the study.
• Because of the nature of COVID-19, participants enrolled on this study with COVID-19 associated pneumonia may have been previously enrolled in other IND trials for their cancer diagnosis or for COVID-19. These enrollments will not exclude them from enrollment to this study.

Exclusion criteria

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