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Cochrane COVID-19 Study Register
Study record
NCT04293692First Published: 2020 Apr 1Updated Date: 2020 Sep 15

Human Umbilical Cord Mesenchymal Stem Cells Treatment for Pneumonia Patients Infected by 2019 Novel Coronavirus

  1. Study Type
  2. Interventional
  1. Study Aim
  2. Treatment and Management
  1. Study Design
  2. Parallel/Crossover
  1. Intervention Assignment
  2. Randomised
  1. Population (6)
  2. Male and Female
  3. COVID-19
  4. Adult
  5. Aged (65+)
  1. Intervention (1)
  2. Umbilical cord mesenchymal stem cells
  1. Comparison (1)
  2. Placebo
  1. Outcome (11)
  2. CD4+ cell count
  3. Electrocardiograph
  4. C-reactive Protein
  5. Cytokine level
  6. Adverse Event
  7. Death
  8. Oxygen Saturation
  9. CD8+ cell count
  10. T-cell count
  11. Chest Imaging
  12. Sequential Organ Failure Assessment Score
Reference record

Therapy for Pneumonia Patients iInfected by 2019 Novel Coronavirus

Puren Hospital Affiliated to Wuhan University of Science and Technology
First Published (first received 2020 Mar 3)ClinicalTrials.gov (https://clinicaltrials.gov/show/NCT04293692)
Trial registry record
No Results
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