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Allogenic Mesenchymal Stromal Cells and Their Extracellular Vesicles in Covid-19 Induced Ards: A Randomized Controlled Trial Publisher Pubmed



Zarrabi M1 ; Shahrbaf MA1 ; Nouri M1 ; Shekari F2, 3 ; Hosseini SE4 ; Hashemian SMR5 ; Aliannejad R6 ; Jamaati H5 ; Khavandgar N6 ; Alemi H6 ; Madani H1 ; Nazari A3 ; Amini A3 ; Hassani SN2, 3 Show All Authors
Authors
  1. Zarrabi M1
  2. Shahrbaf MA1
  3. Nouri M1
  4. Shekari F2, 3
  5. Hosseini SE4
  6. Hashemian SMR5
  7. Aliannejad R6
  8. Jamaati H5
  9. Khavandgar N6
  10. Alemi H6
  11. Madani H1
  12. Nazari A3
  13. Amini A3
  14. Hassani SN2, 3
  15. Abbasi F3
  16. Jarooghi N3
  17. Fallah N3
  18. Taghiyar L2
  19. Ganjibakhsh M3, 7
  20. Hajizadehsaffar E1, 3
  21. Vosough M1
  22. Baharvand H1, 2, 8

Source: Stem Cell Research and Therapy Published:2023


Abstract

Background and aims: The main causes of death in patients with severe Coronavirus disease-2019 (COVID-19) are acute respiratory distress syndrome (ARDS) and multiorgan failure caused by a severe inflammatory cascade. Novel treatment strategies, such as stem-cell-based therapy and their derivatives can be used to relieve inflammation in these cases. In this study, we aimed to evaluate the safety and efficacy of therapy using mesenchymal stromal cells (MSCs) and their derived extracellular vesicles in COVID-19 patients. Materials and methods: COVID-19 patients with ARDS were included in this study and allocated into two study and control groups using block randomization. While all patients received recommended treatment based on guidelines from the national advisory committee for COVID-19 pandemic, the two intervention groups received two consecutive injections of MSCs (100 × 106 cells) or one dose of MSCs (100 × 106 cells) followed by one dose of MSC-derived extracellular vesicles (EVs). Patients were assessed for safety and efficacy by evaluating clinical symptoms, laboratory parameters, and inflammatory markers at baseline and 48 h after the second intervention. Results: A total number of 43 patients (the MSC alone group = 11, MSC plus EV group = 8, and control group = 24) were included in the final analysis. Mortality was reported in three patients in the MSC alone group (RR: 0.49; 95% CI 0.14–1.11; P = 0.08); zero patient in the MSC plus EV group (RR: 0.08; 95% CI 0.005–1.26; P = 0.07) and eight patients in the control group. MSC infusion was associated with a decrease in inflammatory cytokines such as IL-6 (P = 0.015), TNF-α (P = 0.034), IFN-γ (P = 0.024), and CRP (P = 0.041). Conclusion: MSCs and their extracellular vesicles can significantly reduce the serum levels of inflammatory markers in COVID-19 patients, with no serious adverse events. Trial registration IRCT, IRCT registration number: IRCT20200217046526N2. Registered 13th April 2020, http://www.irct.ir/trial/47073 . © 2023, The Author(s).
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