Treatment of Severe COVID-19 Pneumonia With Allogeneic Mesenchymal Stromal Cells (COVID_MSV)

Summary

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Description

Novel coronavirus COVID-19 has spread quickly from Wuhan China to worldwide. On 15 April 2020, the World Health Organization (WHO) has reported 1.914.916 confirmed cases and 123.010 deaths globally, being a severe threat to public health. Some patients develop overwhelming lung inflammation and acut...

Novel coronavirus COVID-19 has spread quickly from Wuhan China to worldwide. On 15 April 2020, the World Health Organization (WHO) has reported 1.914.916 confirmed cases and 123.010 deaths globally, being a severe threat to public health. Some patients develop overwhelming lung inflammation and acute respiratory failure. Several reports demonstrated that COVID-19 specifically recognized the angiotensin I converting ezyme 2 repector (ACE2) and ACE2-positive cells are infected by the virus. ACE2 receptor is widely present on the human cells surface such as alveolar type II cells and capillary endothelium, among others. COVID-19 infects cells and stimulates a terrible cytokine storm in the lung followed by edema, dysfunction of the air exchange and acute respiratory distress which may lead to death. Further, once COVID-19 enters in blood circulation, it can easy spread to some systems and organs, causing significant damage. Under these circumstances, it is reasonable to believe that the inhibition of inflammatory response is the key to treat COVID-19 pneumonia. Mesenchymal stem cells (MSCs) have been widely used in the immune-mediated inflammatory diseases. MSCs can regulate both innate and adaptive immunity by suppressing the proliferation, differentiation and activation of different cells. Some studies have shown that MSCs can significantly reduce acute lung injury in mice caused by H9N2 and H5N1 virus, reducing proinflammatory cytokines and inflammatory cells into the lungs. These immunomodulatory properties of MSCs support performance of the Phase I/II, double-blind (neither the participant nor the investigator will know if active drug or placebo is assigned), placebo-controlled, randomized (assigned by chance), in which subjects with severe COVID-19 pneumonia shall be received either MSCs (1 million cells/kg) or placebo by intravenous injection. The administration of cells will be done only once.

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