Cell-Based Therapies for COVID-19: Proper Clinical Investigations are Essential

Khoury, Maroun; Rocco, Patricia R.M.; Phinney, Donald G; Krampera, Mauro; Martin, Ivan; Viswanathan, Sowmya; Nolta, Jan A.; LeBlanc, Katarina; Galipeau, Jacques; Weiss, Daniel J.

Abstract The serious consequences of the global COVID-19 pandemic have prompted a rapid gobal 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 the acute respiratory distress syndrome (ARDS), but whether these therapies are effective for treating respiratory virus-induced ARDS is unknown. According to the WHO ICTRP and the NIH clinicaltrials.gov databases, 27 clinical investigations of MSC-based cell therapy approaches have begun in China since the onset of the COVID-19 outbreak, as well as a growing number of academic and industry trials elsewhere. Several recent published reports have suggested potential efficacy; however, the available data presented is either anecdotal or from incomplete, poorly controlled investigations. Therefore, while 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. We urge that the field proceeds by finding balance between swift experimentation and communication of results, and scientifically coherent generation and analysis of clinical data.