This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications.
Biological: PLX-PAD
PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells
Biological: Placebo
Placebo solution for injection
Key Inclusion Criteria:
- Willing and able to provide written informed consent, or with a legal representative
who can provide informed consent.
- Male or non-pregnant female adult 40-80 years of age at time of enrollment.
- Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in any specimen up to
21 days prior to randomization.
- Meets definition of ARDS according to Berlin criteria.
Key Exclusion Criteria:
- Body weight under 55 kg (121 lbs)
- Serum creatinine level of over 1.5 mg/dL at time of randomization.
- Total Bilirubin ≥2 mg/dL at time of randomization.
- Known allergy to any of the following: dimethyl sulfoxide (DMSO), human serum albumin,
bovine serum albumin.
- Stroke or acute myocardial infarction/unstable angina within 3 months prior to
randomization.
- Chronic Obstructive Pulmonary disease GOLD stage above II.
University of California Irvine
Irvine, California, United States
University of Southern California (USC) - Keck School of Medicine (KSOM)
Los Angeles, California, United States
University Of California Davis,4860 Y Street
Sacramento, California, United States
Baptist Health Medical Center
Jacksonville, Florida, United States
Medical College of Georgia at Augusta University
Augusta, Georgia, United States
Sarah Cannon Research Institute, LLC (Mercer University School of Medicine)
Macon, Georgia, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Cooper Research Institute
Camden, New Jersey, United States
Holy Medical Center
Teaneck, New Jersey, United States
Montefiore Medical Center
New York, New York, United States
Maimonides Medical Center
New York, New York, United States
Mercy Medical Center
New York, New York, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States