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Human Placenta-Derived Mesenchymal Stem Cells Transplantation in Patients With Acute Respiratory Distress Syndrome (Ards) Caused by Covid-19 (Phase I Clinical Trial): Safety Profile Assessment Publisher Pubmed



Aghayan HR1 ; Salimian F2 ; Abedini A3 ; Fattah Ghazi S4 ; Yunesian M5 ; Alavimoghadam S1 ; Makarem J4 ; Majidzadeha K6 ; Hatamkhani A2 ; Moghri M2 ; Danesh A3 ; Haddadmarandi MR2 ; Sanati H2 ; Abbasvandi F2 Show All Authors
Authors
  1. Aghayan HR1
  2. Salimian F2
  3. Abedini A3
  4. Fattah Ghazi S4
  5. Yunesian M5
  6. Alavimoghadam S1
  7. Makarem J4
  8. Majidzadeha K6
  9. Hatamkhani A2
  10. Moghri M2
  11. Danesh A3
  12. Haddadmarandi MR2
  13. Sanati H2
  14. Abbasvandi F2
  15. Arjmand B1
  16. Azimi P7
  17. Ghavamzadeh A8
  18. Sarramiforooshani R2
Show Affiliations
Authors Affiliations
  1. 1. Cell Therapy and Regenerative Medicine Research Center, Endocrinology and Metabolism Molecular-Cellular Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. ATMP Department, Breast Cancer Research Center, Motamed Cancer Institute, ACECR, P.O. BOX: 15179/64311, Tehran, Iran
  3. 3. Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran
  4. 4. Department of Anesthesiology and Critical Care, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
  5. 5. Department of Environmental Health Engineering, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
  6. 6. Genetics Department, Breast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran
  7. 7. Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran
  8. 8. Cancer and Cell Therapy Research Center, Tehran University of Medical Sciences, Tehran, Iran

Source: Stem Cell Research and Therapy Published:2022


Abstract

Background: High morbidity and mortality rates of the COVID-19 pandemic have made it a global health priority. Acute respiratory distress syndrome (ARDS) is one of the most important causes of death in COVID-19 patients. Mesenchymal stem cells have been the subject of many clinical trials for the treatment of ARDS because of their immunomodulatory, anti-inflammatory, and regenerative potentials. The aim of this phase I clinical trial was the safety assessment of allogeneic placenta-derived mesenchymal stem cells (PL-MSCs) intravenous injection in patients with ARDS induced by COVID-19. Methods: We enrolled 20 patients suffering from ARDS caused by COVID-19 who had been admitted to the intensive care unit. PL-MSCs were isolated and propagated using a xeno-free/GMP compliant protocol. Each patient in the treatment group (N = 10) received standard treatment and a single dose of 1 × 106 cells/kg PL-MSCs intravenously. The control groups (N = 10) only received the standard treatment. Clinical signs and laboratory tests were evaluated in all participants at the baseline and during 28 days follow-ups. Results: No adverse events were observed in the PL-MSC group. Mean length of hospitalization, serum oxygen saturation, and other clinical and laboratory parameters were not significantly different in the two groups (p > 0.05). Conclusion: Our results demonstrated that intravenous administration of PL-MSCs in patients with COVID-19 related ARDS is safe and feasible. Further studies whit higher cell doses and repeated injections are needed to evaluate the efficacy of this treatment modality. Trial registration: Iranian Registry of Clinical Trials (IRCT); IRCT20200621047859N4. Registered 1 March 2021, https://en.irct.ir/trial/52947. © 2022, The Author(s).
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