The coronavirus pandemic: a pitfall or a fast-track for validating cell therapy products?

Khoury, Maroun; Ikonomou, Laertis; Dominici, Massimo; Le Blanc, Katarina; Levine, Bruce L; Weiss, Dan J

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 being investigated worldwide for SARS-CoV-2-induced lung diseases. A significant number of academic centers and companies globally have already initiated such trials. At a time of unprecedented need, it is it is also foreseen that distressed families, and caregivers to seek all available options including access to cell-based and other investigational products, even prior to its 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.