This is a Phase 2 multicenter randomized (2:1), placebo-controlled trial to evaluate early signs of efficacy of allogeneic, umbilical cord-derived (UC) mesenchymal stromal cells (MSCs) in patients with COVID-19 and Acute Respiratory Distress Syndrome (ARDS). Randomized participants (N=54) will receive 3 daily doses of up to 90-million cells/unit dose (cumulative dose of up to 270 million UC-MSCs) or blinded placebo. The MSC product will be provided as 2.5 million cells/ml suspended in PlasmaLyte A containing 5% Human Albumin. The appearance-matched placebo product contains the same excipients, PlasmaLyte A and 5% Human Albumin, as the UC-MSCs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
22
3 daily doses of up to 90-million cells/unit dose (cumulative dose of up to 270 million UC-MSCs)
PlasmaLyte A and 5% Human Albumin
Lakeridge Health
Oshawa, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Number of days free of oxygen by NIV/HFNC or mechanical ventilation at Day 28
Time frame: Day 28
Biomarkers of systemic inflammatory response
Interleukin levels change from Baseline to 24 hours after each MSC infusion
Time frame: Change from Baseline to 24 hours after each MSC infusion
Biomarkers of endothelial function
Angiopoietin levels change from Baseline to 24 hours after each MSC infusion
Time frame: Change from Baseline to 24 hours after each MSC infusion
ICU mortality
Number of deaths at day 28
Time frame: Day 28
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