COVID-19 Clinical Trial
Official title:
Human Umbilical Cord Mesenchymal Stem Cells Treatment for Pneumonia Patients Infected by 2019 Novel Coronavirus
The 2019 novel coronavirus pneumonia outbroken in Wuhan, China, which spread quickly to 26 countries worldwide and presented a serious threat to public health. It is mainly characterized by fever, dry cough, shortness of breath and breathing difficulties. Some patients may develop into rapid and deadly respiratory system injury with overwhelming inflammation in the lung. Currently, there is no effective treatment in clinical practice. The present clinical trial is to explore the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) therapy for novel coronavirus pneumonia patients.
Since late December 2019, human pneumonia cases infected by a novel coronavirus (2019-nCoV)
were firstly identified in Wuhan, China. As the virus is contagious and of great epidemic,
more and more cases have found in other areas of China and abroad. Up to February 24, a total
of 77, 779 confirmed cases were reported in China. At present, there is no effective
treatment for patients identified with novel coronavirus pneumonia. Therefore, it's urgent to
explore more active therapeutic methods to cure the patients.
Recently, some clinical researches about the 2019 novel coronavirus pneumonia published in
The Lancet and The New England Journal of Medicine suggested that massive inflammatory cell
infiltration and inflammatory cytokines secretion were found in patients' lungs, alveolar
epithelial cells and capillary endothelial cells were damaged, causing acute lung injury. It
seems that the key to cure the pneumonia is to inhibit the inflammatory response, resulting
to reduce the damage of alveolar epithelial cells and endothelial cells and repair the
function of the lung.
Mesenchymal stem cells (MSCs) are widely used in basic research and clinical application.
They are proved to migrate to damaged tissues, exert anti-inflammatory and immunoregulatory
functions, promote the regeneration of damaged tissues and inhibit tissue fibrosis. Studies
have shown that MSCs can significantly reduce acute lung injury in mice caused by H9N2 and
H5N1 viruses by reducing the levels of proinflammatory cytokines and the recruitment of
inflammatory cells into the lungs. Compared with MSCs from other sources, human umbilical
cord-derived MSCs (UC-MSCs) have been widely applied to various diseases due to their
convenient collection, no ethical controversy, low immunogenicity, and rapid proliferation
rate. In our recent research, we confirmed that UC-MSCs can significantly reduce inflammatory
cell infiltration and inflammatory factors expression in lung tissue, and significantly
protect lung tissue from endotoxin (LPS) -induced acute lung injury in mice.
The purpose of this clinical study is to investigate safety and efficiency of UC-MSCs in
treating pneumonia patients infected by 2019-nCoV. The investigators planned to recruit 48
patients aged from 18 to 75 years old and had no severe underlying diseases. In the cell
treatment group, 24 patients received 0.5*10E6 UC-MSCs /kg body weight intravenously
treatment 4 times every other day besides conventional treatment. In the control group, other
24 patients received 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.
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