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.
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX PAD for the Treatment of Severe COVID-19
COVID, ARDS, PLX-PAD
You can join if…
Open to people ages 40-80
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.
You CAN'T join if...
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 92868 United States
University of Southern California (USC) - Keck School of Medicine (KSOM) Los Angeles California 90033 United States