Brief Summary:
The 2019 novel coronavirus pneumonia first emerged in Wuhan, Hubei, China, in December 2019. The disease spread quickly to 26 countries worldwide representing a serious global public health threat. Common signs of infection include respiratory symptoms, fever, dry cough, shortness of breath and breathing difficulties. In more severe cases, the infection can cause pneumonia, severe acute respiratory system injury with overwhelming inflammation in the lung. To date, there are no anti-viral therapeutics that specifically target human coronaviruses, so treatments are only supportive. The present clinical trial is aimed to evaluate the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) for the therapy of novel coronavirus pneumonia patients.
Detailed description:
In late December 2019, patients presenting with viral pneumonia due to an unidentified microbial agent were reported in Wuhan, China. A novel coronavirus was subsequently identified as the causative pathogen, provisionally named 2019 novel coronavirus (2019-nCoV).
The virus that causes COVID-19 is infecting people and highly contagious, spreading easily from person-to-person. The number of infected cases is growing in China and worldwide. As of February 20, a total of 54,959 confirmed cases were reported in China. To date, there is no effective treatment for patients affected with novel coronavirus pneumonia, and new therapeutic methods for the treatment of patients are urgently needed.
A recent study regarding the 2019 novel coronavirus pneumonia, published in The Lancet and The New England Journal of Medicine, discovered the massive inflammatory cell infiltration and inflammatory cytokines secretion in patients’ lungs, alveolar epithelial cells, causing damage of capillary endothelial cells and acute lung injury. Based on this discovery, it seems that the key to cure pneumonia is to inhibit the inflammatory response. This will reduce the damage of alveolar epithelial cells and endothelial cells and repair the function of the lung.
Mesenchymal stem cells (MSCs) are extensively used in basic research and clinical application. Research shows that these cells can migrate to damaged tissues, exert anti-inflammatory and immunoregulatory functions, promote the regeneration of damaged tissues and inhibit tissue fibrosis. Studies are showing that MSCs can significantly reduce H9N2 and H5N1 viruses induced acute lung injury in mice model by bringing down the level of proinflammatory cytokines and mobilizing the inflammatory cells in the lungs.
Compared to MSCs from other sources, human umbilical cord-derived MSCs (UC-MSCs) have been commonly used in clinical studies due to their convenient collection, lack of ethical concerns, low immunogenicity, and rapid proliferation rate. In our recent research studies, we confirmed that UC-MSCs can significantly reduce inflammatory cell infiltration and inflammatory factors expression in lung tissue, significantly protecting lung tissue from endotoxin (LPS) -induced acute lung injury in mice.
The purpose of this clinical study is to evaluate the safety and efficiency of UC-MSCs in the therapy of pneumonia patients infected by 2019-nCoV. We are planning to recruit 48 participants aged from 18 to 75 years old with no severe underlying diseases. In the experimental group, 24 participants will receive intravenous administration of 0.5*106 UC-MSCs/kg body weight (4 administrations every other day in conjunction with conventional therapy). In the control group, the other 24 participants will receive conventional treatment plus 4 times of placebo intravenously. The lung CT, blood biochemical examination, lymphocyte subsets, inflammatory factors, 28-days mortality, etc. will be evaluated within 24h and 1, 2, 4, 8 weeks after UC-MSCs treatment.