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.
Shu, 2020 ChiCTR2000031494
stem cells (n=12) vs. standard of care (n=29)
randomized controlled trial
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.
