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
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 18-85 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.
Charite Campus Virchow
Berlin, Germany
Campus Benjamin Franklin - CBF Charité - Universitätsmedizin
Berlin, Germany
University of hospital Bonn
Bonn, Germany
Hospital Cologne-Merheim
Köln, Germany
Emek Medical Center
Afula, Israel
Bnai Zion Medical Center
Haifa, Israel
Rambam Health Care Campus
Haifa, Israel
Galilee Medical Center
Nahariya, Israel
Baruch Padeh Medical Center, Poriya
Tiberias, Israel