Treatment of severe COVID-19 with human umbilical cord mesenchymal stem cells

TLDR

COVID‑19 is a highly infectious respiratory disease, and no therapeutics have yet proven effective for treating severe COVID‑19. The study aims to determine whether human umbilical cord mesenchymal stem cell infusion is effective and safe for treating severe COVID‑19. Patients with severe COVID‑19 were randomized to standard treatment alone or standard treatment plus hUC‑MSC infusion, and outcomes such as progression to critical illness, 28‑day mortality, symptom improvement, laboratory markers, and imaging were compared. The hUC‑MSC group showed no progression to critical illness, a 0 % 28‑day mortality versus 10.34 % in controls, faster clinical improvement, earlier symptom resolution, lower CRP and IL‑6, quicker lymphocyte recovery, and faster lung inflammation absorption on CT. Clinical trial ChiCTR2000031494 (registered 2 April 2020) is available at http://www.medresman.org.

Abstract

COVID-19 is a highly infectious respiratory disease. No therapeutics have yet been proven effective for treating severe COVID-19.To determine whether human umbilical cord mesenchymal stem cell infusion may be effective and safe for the treatment of severe COVID-19.Patients with severe COVID-19 were randomly divided into 2 groups: the standard treatment group and the standard treatment plus hUC-MSC infusion group. The incidence of progression from severe to critical illness, 28-day mortality, clinical symptom improvement, time to clinical symptom improvement, hematologic indicators including C-reactive protein, lymphocyte number, and interleukin 6, and imaging changes were observed and compared between the two groups.The incidence of progression from severe to critical illness and the 28-day mortality rate were 0 in the hUC-MSC treatment group, while 4 patients in the control group deteriorated to critical condition and received invasive ventilation; 3 of them died, and the 28-day mortality rate was 10.34%. In the hUC-MSC treatment group, the time to clinical improvement was shorter than that in the control group. Clinical symptoms of weakness and fatigue, shortness of breath, and low oxygen saturation obviously improved beginning on the third day of stem cell infusion and reached a significant difference on day 7. CRP and IL-6 levels were significantly lower from day 3 of infusion, the time for the lymphocyte count to return to the normal range was significantly faster, and lung inflammation absorption was significantly shorter on CT imaging in the hUC-MSC group than in the control group.Intravenous transplantation of hUC-MSCs is a safe and effective method that can be considered a salvage and priority treatment option for severe COVID-19.Chinese Clinical Trial Registration; ChiCTR2000031494; Registered on 2 April 2020; http:// www.medresman.org.