Abstract
The global COVID-19 pandemic has prompted urgent need for potential therapies for severe respiratory consequences resulting from coronavirus infection. New therapeutic agents that will attenuate ongoing inflammation and at the same time promote regeneration of injured lung epithelial cells are urgently needed. Cell-based therapies, primarily involving mesenchymal stromal cells (MSCs) and their derivatives, are currently investigated worldwide for SARS-CoV-2-induced lung diseases. A significant number of academic centers and companies globally have already initiated such trials. However, at a time of unprecedented need, it is also foreseen that families and caregivers will seek all available options, including access to cell-based and other investigational products, even before proven safety and efficacy as well as regulatory approval. This should not be an excuse for opportunists to sell or advertise unproven therapies of any kind. "Compassionate use" should be conducted in the context of a clinical investigation framed by strict ethical and regulatory permissions, with the goal of obtaining mechanistic information wherever possible.
Highlights
2 Abstract: The global COVID-19 pandemic has prompted urgent need for potential therapies for severe respiratory consequences resulting from coronavirus infection
At a time of unprecedented need, it is foreseen that families and caregivers will seek all available options including access to cell-based and other investigational products, even prior to proven safety and efficacy as well as regulatory approval
This should not be an excuse for opportunists to sell or advertise unproven therapies of any kind
Summary
NCT04345 l Stromal group: 601/ Cells for the up to two Baylor Treatment of infusions of. Mesoblast , NY, New York for the Treatment of Moderate to Severe COVID-19 Acute Respiratory. Syndrome remestemcel -L plus standard of care, BM-MSC administered / twice during 1 x the first 10^6/kg week, with the second infusion at 4 days following the first injection (± 1 day). 16 MCSs along with heparin in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second within 72 hours. Control group: Best supportive care treatment per the treating hospital protocol, with 2
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