meta|Evidence - COVID-19
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stem cells (n=12) vs. placebo (n=12)
randomized controlled trial some concerns about risk of bias
Umbilical cord mesenchymal stem cell (UC-MSC)
Two intravenous infusions of 100 ± 20 × 106 UC-MSCs each, in 50 mL vehicle solution containing human serum albumin and heparin, infused over10 ± 5 minutes, at days 0 and 3.
Placebo
Two infusions of 50 mL vehicle solution, at day 0 and day 3.
Best standard of care was provided in both groups following the current institutional COVID-19 guidelines.
COVID 19 hospitalized
Patient hospitalized; age ≥ 18 years; peripheral capillary oxygen saturation (SpO2) ≤ 94% at room 134air, or requiring supplemental oxygen at screening; PaO2/FiO2 ratio < 300 mmHg; and bilateral infiltrates on frontal chest radiograph or bilateral ground glass opacities on a chest CT scan.
Double-blind.
Single-center, UHealth System/Jackson Health System (UHS/JHS), in Miami, Florida, United-States.
Phase 1/2a.
stem cells (n=66) vs. placebo (n=35)
randomized controlled trial some concerns about risk of bias
Human umbilical cord mesenchymal stem cells (UC-MSCs)
UC-MSCs (4 × 107 cells per infusion) on day 0, 3 and 6.
Placebo
Saline containing 1% Human serum albumin (solution without UC-MSCs). Infusion on day 0, 3, 6.
2:1 ratio. All patients received standard of care.
COVID-19 severe or critically
Hospitalized patients with severe COVID-19 with laboratory-confirmed SARS-CoV-2 infection by reverse transcription polymerase chain reaction (RT-PCR) with severe COVID-19 diagnosed after onset of disease; or chest computed tomography (CT) imaging confirmed pneumonia combined with lung damage. Patients with shock or COVID-19 combined with any one of other organ failures or who received invasive ventilation were excluded.
Double-blind.
Wuhan, China.
Phase II.
stem cells (n=12) vs. standard of care (n=29)
randomized controlled trial some concerns about risk of bias
Umbilical cord mesenchymal stem cell infusion (hUC-MSCs)
Umbilical cord mesenchymal stem cell intravenous infusion plus standard of care. Before the intravenous drip, the MSCs were suspended in 100 ml of normal saline, and the total number of transplanted cells was calculated as 2 × 106 cells/kg. The infusion was from the patients’ right cubital veins and lasted approximately 1 h (35 drops/min).
Standard treatment
Supplemental oxygen (noninvasive or invasive ventilation); antiviral agents (abidor/oseltamivir); antibiotic agents (moxifloxacin is taken orally; if there is clear evidence of bacteriological infection, the choice of antibacterial drugs is based on a drug sensitivity test), and glucocorticoid therapy (1-2 mg/kg, less than a week).
Standard treatments in both groups.
COVID-19 severe or critically
Criteria for severe disease are A) an epidemiological history; B) etiological evidence (i.e., a positive SARS-CoV-2 nucleic acid test by the real time reverse transcription polymerase chain reaction (RT-PCR) assay for SARS-CoV-2 RNA from the Chinese Center for Disease Control and Prevention); AND C) CT imaging indicators of pneumonia. In addition, these factors should coincide with any of the following criteria: (a) respiratory distress, respiration rate (RR) ≥ 30 times/min; (b) oxygen saturation ≤93% in the resting state; and (c) PaO2/FiO2 ≤ 300 mmHg (1 mmHg = 0.133 kPa).
Open-label.
Single-center, Huangshi Hospital of Traditional Chinese Medicine in Hubei Province, China.
NEWS2 score and seven category ordinal scale were used to assess the clinical symptoms and conditions of the enrolled patients.
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