Umbilical cord mesenchymal stromal cells as critical COVID‐19 adjuvant therapy: A randomized controlled trial

Stem Cells Translational Medicine

Adhrie Sugiarto¹  Dita Aditianingsih¹  Andri M.T. Lubis²  Triya Damayanti³  Erlina Burhan³  Nina Mariana⁴  Pompini Agustina Sitompul⁵  Isabella Kurnia Liem⁶  Novialdi Novialdi⁶  Dina Rahmatika⁶  Ismail Hadisoebroto Dilogo⁶  Tera Kispa⁶  Fajar Mujadid⁶  Tri Kurniawati⁶  Evah Luviah⁷  Radiana D. Antarianto⁷ 

[1] Department of Anesthesiology and Intensive Care Universitas Indonesia Cipto Mangunkusumo Hospital Jakarta Indonesia;Department of Orthopaedic and Traumatology, Cipto Mangunkusumo General Hospital Faculty of Medicine Universitas Indonesia Jakarta Indonesia;Department of Pulmonology and Respiratory Medicine Faculty of Medicine Universitas Indonesia, Persahabatan General Hospital Jakarta Indonesia;Directorate of Human Resources Development Education and Operational Sulianti Saroso Infection Disease Hospital Jakarta Indonesia;Directorate of Medical Services, Nursing and Supporting Sulianti Saroso Infection Disease Hospital Jakarta Indonesia;Stem Cell Medical Technology Integrated Service Unit, Cipto Mangunkusumo Central Hospital Faculty of Medicine Universitas Indonesia Jakarta Indonesia;Stem Cell and Tissue Engineering Research Cluster Indonesian Medical Education and Research Institute (IMERI) Universitas Indonesia Jakarta Indonesia;

关键词: adjuvants;    cord stem cell transplantation;    COVID‐19;    cytokine release syndrome;    immunology;    mesenchymal stromal cells;   

DOI  :  10.1002/sctm.21-0046

来源: DOAJ

【 摘 要 】

Abstract One of the main causes of acute respiratory distress syndrome in coronavirus disease 2019 (COVID‐19) is cytokine storm, although the exact cause is still unknown. Umbilical cord mesenchymal stromal cells (UC‐MSCs) influence proinflammatory T‐helper 2 (Th2) cells to shift to an anti‐inflammatory agent. To investigate efficacy of UC‐MSC administration as adjuvant therapy in critically ill patients with COVID‐19, we conducted a double‐blind, multicentered, randomized controlled trial at four COVID‐19 referral hospitals in Jakarta, Indonesia. This study included 40 randomly allocated critically ill patients with COVID‐19; 20 patients received an intravenous infusion of 1 × 106/kg body weight UC‐MSCs in 100 ml saline (0.9%) solution (SS) and 20 patients received 100 ml 0.9% SS as the control group. All patients received standard therapy. The primary outcome was measured by survival rate and/or length of ventilator usage. The secondary outcome was measured by clinical and laboratory improvement, with serious adverse events. Our study showed the survival rate in the UC‐MSCs group was 2.5 times higher than that in the control group (P = .047), which is 10 patients and 4 patients in the UC‐MSCs and control groups, respectively. In patients with comorbidities, UC‐MSC administration increased the survival rate by 4.5 times compared with controls. The length of stay in the intensive care unit and ventilator usage were not statistically significant, and no adverse events were reported. The application of infusion UC‐MSCs significantly decreased interleukin 6 in the recovered patients (P = .023). Therefore, application of intravenous UC‐MSCs as adjuvant treatment for critically ill patients with COVID‐19 increases the survival rate by modulating the immune system toward an anti‐inflammatory state.

【 授权许可】

Unknown