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Cell-based therapies for coronavirus disease 2019: proper clinical investigations are essential
Institution:1. Laboratory of Nano-Regenerative Medicine, Faculty of Medicine, Universidad de los Andes, Santiago, Chile;2. Cells for Cells and Consorcio Regenero, Chilean Consortium for Regenerative Medicine, Santiago, Chile;3. Laboratory of Pulmonary Investigation, Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil;4. National Institute of Science and Technology for Regenerative Medicine, Rio de Janeiro, Brazil;5. Department of Molecular Medicine, The Scripps Research Institute, Jupiter, Florida, USA;6. Section of Hematology, Department of Medicine, University of Verona, Verona, Italy;7. Department of Biomedicine, University Hospital Basel, University of Basel, Basel, Switzerland;8. Krembil Research Institute, University Health Network, Toronto, Canada;9. Institute of Biomaterials and Biomedical Engineering and Department of Medicine, University of Toronto, Toronto, Canada;10. Institute for Regenerative Cures, University of California Davis Health, Sacramento, California, USA;11. Department of Laboratory Medicine, Karolinska Institutet, Cell Therapy and Allogeneic Stem Cell Transplant, Patient Area Cell Therapies and Allogeneic Stem Cell Transplantation, Karolinska University Hospital, Stockholm, Sweden;12. Department of Medicine, University of Wisconsin Carbone Comprehensive Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin, USA;13. Department of Medicine, University of Vermont, Burlington, Vermont, USA
Abstract:The serious consequences of the global coronavirus disease 2019 (COVID-19) pandemic have prompted a rapid global response to develop effective therapies that can lessen disease severity in infected patients. Cell-based approaches, primarily using mesenchymal stromal cells (MSCs), have demonstrated a strong safety profile and possible efficacy in patients with acute respiratory distress syndrome (ARDS), but whether these therapies are effective for treating respiratory virus-induced ARDS is unknown. According to the World Health Organization International Clinical Trials Registry Platform and the National Institutes of Health ClinicalTrials.gov databases, 27 clinical investigations of MSC-based cell therapy approaches have begun in China since the onset of the COVID-19 outbreak, with a growing number of academic and industry trials elsewhere as well. Several recent published reports have suggested potential efficacy; however, the available data presented are either anecdotal or from incomplete, poorly controlled investigations. Therefore, although there may be a potential role for MSCs and other cell-based therapies in treatment of COVID-19, these need to be investigated in a rationally designed, controlled approach if safety and efficacy are to be demonstrated accurately. The authors urge that the field proceed by finding a balance between swift experimentation and communication of results and scientifically coherent generation and analysis of clinical data.
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