Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available. For severe cases, it was found that aberrant pathogenic T cells and inflammatory monocytes are rapidly activated and then producing a large number of cytokines and inducing an inflammatory storm.Mesenchymal stem cells (MSCs) have been shown to possess a comprehensive powerful immunomodulatory function. This study aims to investigate the safety and efficacy of intravenous infusion of mesenchymal stem cells in severe patients with COVID-19.
COVID-19 has become a urgent and serious public health event that threatens human life and health globally. No specific pharmacological treatments are available to date for COVID-19.Patients contracting the severe form of the disease constitute approximately 15% of the cases which is characterized by extensive acute inflammation. In these severe cases, there will be rapid respiratory system failure. MSCs have been employed extensively in cell therapy, which includes a plethora of preclinical research investigations as well as a significant number of clinical trials. Safety and efficacy have been shown in many clinical trials. Previous studies have shown that MSCs could significantly reduce inflammatory cell infiltration in lung tissue, reduce inflammation in lung tissue, and significantly improve lung The structure and function of tissues protect lung tissue from damage.The mechanisms underlying the improvements after MSC infusion in COVID-19 patients also appeared to be the robust antiinflammatory activity of MSCs. Recent studies also showed that intravenous MSC infusion could reduce the overactivation of the immune system and support repair by modulating the lung microenvironment after SARS-CoV-2 infection. MSC therapy inhibiting the overactivation of the immune system and promoting endogenous repair by improving the lung microenvironment after the SARS-CoV-2 infection. The purpose of this study is to investigate the safety and efficacy of intravenous infusion of mesenchymal stem cells in severe patients With COVID-19.The respiratory function, pulmonary inflammation, clinical symptoms, pulmonary imaging, side effects, immunological characteristics will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Changes of oxygenation index (PaO2/FiO2)
Evaluation of pneumonia improvement
Time frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.
Side effects in the BM-MSCs treatment group
Proportion of participants with treatment-related adverse events
Time frame: Baseline through 6 months
Clinical outcome
Improvement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea.
Time frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.
Hospital stay
days of the patients in hospital
Time frame: Baseline through 6 months
CT Scan
Evaluation of pneumonia improvement
Time frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.
Changes in viral load
(deep sputum / pharyngeal swab / nasal swab / anal swab / tear fluid / stomach fluid / feces / blood or alveolar lavage fluid)
Time frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.
Changes of CD4+, CD8+ cells count and concentration of cytokines
Immunological status
Time frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.
Rate of mortality within 28-days
Marker for efficacy
Time frame: From baseline to day 28
Changes of C-reactive protein
Markers of Infection
Time frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.
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