Abstract
This study was a double‐blind, randomized, controlled, early phase clinical trial of umbilical cord mesenchymal stem cell treatment in 24 subjects with COVID‐19 acute respiratory distress syndrome. This study demonstrated fewer serious adverse events in the treatment group compared with control. Exploratory efficacy analyses provide evidence of significantly improved patient survival and time to recovery. The observed findings strongly support further investigation in a larger trial designed to estimate and establish efficacy. These observations will inform physicians influencing clinical practice and future research in the fields of acute respiratory distress syndrome, COVID‐19, and other immune‐related disorders.
Primary Endpoints
• Two intravenous infusions of umbilical cord mesenchymal stem cells (UC‐MSCs), at a dose of 100 million cells per infusion, given 72 hours apart, are safe in COVID‐19 patients with acute respiratory distress syndrome.
• This double blind randomized controlled trial in 24 subjects demonstrated fewer serious adverse events in the UC‐MSC treatment group compared with the control group.
• UC‐MSC treatment was associated with a significant decrease in a set of inflammatory cytokines involved in the COVID‐19 “cytokine storm.”
• UC‐MSC treatment was associated with significantly improved patient survival and time to recovery.
Conclusion
This double-blind randomized, controlled clinical study found that mesenchymal stem cells were successfully used to treat COVID-19 patients. We can utilize this information to showcase the potential of mesenchymal stem cells to improve post-acute COVID-19 symptoms that seem to persist over a course of months following initial infection.
The reduction of inflammation and immunomodulatory effects of mesenchymal stem cells can positively influence ones immune response. This can inhibit the harmful "cytokine storm" that occurs within the pulmonary system post COVID-19 infection.
Reference
1) Lanzoni, G., Linetsky, E., Correa, D., Cayetano, S., Alvarez, R., Kouroupis, D., . . . Ricordi, C. (2021, January 05). Umbilical cord mesenchymal stem cells for COVID‐19 acute respiratory Distress syndrome: A DOUBLE‐BLIND, phase 1/2a, randomized controlled trial. Retrieved March 26, 2021, from https://stemcellsjournals.onlinelibrary.wiley.com/doi/10.1002/sctm.20-0472