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ASJ 2022, 19(2): 79-88 |
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Jahedi Zargar M, Heidari Keshel S, Kaviani S, Zahraei M, Izadyari Aghmiuni A, Savadkoohi A A, et al et al . Safety and efficacy of placental mesenchymal stem cell-derived extracellular vesicle in severe COVID-19 patients: Phase I & II Clinical Trials. ASJ 2022; 19 (2) :79-88
URL: http://anatomyjournal.ir/article-1-585-en.html
URL: http://anatomyjournal.ir/article-1-585-en.html
Mehdi Jahedi Zargar1 
, Saeed Heidari Keshel2 
, Saeid Kaviani1 , Mohammad Zahraei3 , Azadeh Izadyari Aghmiuni4 , Ali Amir Savadkoohi5 , Hamidreza Jamaati6 , Mohammad Samet7 , Mahsa Soufizomorrod8 , Mina Soufi Zomorrod9 , Faeze Sadat Heidari10 , Mohamad Reza Mirjalili11 , Payam Tabarsi12 , Mohammadreza Soroush3 , Rasoul Aliannejad13 , Mojtaba Javani14 , Hosein Shafiii14 , Mohammad Vasei15 , Masoud Soleimani 2
, Saeed Heidari Keshel2 , Saeid Kaviani1 , Mohammad Zahraei3 , Azadeh Izadyari Aghmiuni4 , Ali Amir Savadkoohi5 , Hamidreza Jamaati6 , Mohammad Samet7 , Mahsa Soufizomorrod8 , Mina Soufi Zomorrod9 , Faeze Sadat Heidari10 , Mohamad Reza Mirjalili11 , Payam Tabarsi12 , Mohammadreza Soroush3 , Rasoul Aliannejad13 , Mojtaba Javani14 , Hosein Shafiii14 , Mohammad Vasei15 , Masoud Soleimani 2
1- Department of Hematology, Faculty of Medical Science, Tarbiat Modares University, Tehran, Iran.
2- Department of Tissue Engineering and Applied Cell Science, School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
3- Nikan Education & Research center (NERC), West Nikan Hospital, Tehran, Iran.
4- Department of Nanobiotechnology, Pasteur Institute of Iran, Tehran, Iran.
5- Department of Anesthesia and Critical Care, Mehrad Hospital, Tehran, Iran.
6- Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
7- Department of Internal Medicine, Shahid Sadoughi Hospital, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
8- National Institute of Genetic Engineering and Biotechnology (NIGEB), Tehran, Iran.
9- Department of Applied Cell Science and Hematology, Faculty of Medical Science, Tarbiat Modares University, Tehran, Iran.
10- Department of Infectious Diseases, Infectious Diseases Research Center, School of Medicine, Shahid Sadoughi General Hospital, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
11- Department of Anesthesia and Intensive Care Medicine, Faculty of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
12- Clinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
13- Department of Pulmonary, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.
14- Shahid Sadughi Hospital, Isfahan, Iran.
15- Cell Therapy Based Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Science, Tehran, Iran.
2- Department of Tissue Engineering and Applied Cell Science, School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
3- Nikan Education & Research center (NERC), West Nikan Hospital, Tehran, Iran.
4- Department of Nanobiotechnology, Pasteur Institute of Iran, Tehran, Iran.
5- Department of Anesthesia and Critical Care, Mehrad Hospital, Tehran, Iran.
6- Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
7- Department of Internal Medicine, Shahid Sadoughi Hospital, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
8- National Institute of Genetic Engineering and Biotechnology (NIGEB), Tehran, Iran.
9- Department of Applied Cell Science and Hematology, Faculty of Medical Science, Tarbiat Modares University, Tehran, Iran.
10- Department of Infectious Diseases, Infectious Diseases Research Center, School of Medicine, Shahid Sadoughi General Hospital, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
11- Department of Anesthesia and Intensive Care Medicine, Faculty of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
12- Clinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
13- Department of Pulmonary, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.
14- Shahid Sadughi Hospital, Isfahan, Iran.
15- Cell Therapy Based Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Science, Tehran, Iran.
Abstract: (401 Views)
Introduction: Most mortality in COVID-19 cases was due to the increased inflammatory cytokines and cytokine storm. As mesenchymal stem cells (MSCs) possess immunomodulatory properties, this study assessed the therapeutic effects of placental MSC-derived extracellular vesicles on the inflammation and pulmonary injury caused by COVID-19.
Methods: The study was carried out in phases I (safety study, 101 patients) and II (efficacy study, 80 patients) in a randomized, double-blind study at four hospital centers from April 2021 to August 2021. In addition to standard treatments, 15 mL of normal saline solution containing 15×109 vesicles was injected intravenously for five consecutive days.
Results: No reaction or adverse events were observed in any patients. In the intervention group, after 5 days of treatment, patients’ clinical status and oxygenation improved, and 75% of patients presented an increased SpO2 after 5 days. Besides, inflammatory parameters assessment indicated a 21% decrease in neutrophil-lymphocyte ratio and a 54% reduction in C-reactive protein after day five of the intervention.
Conclusion: PMSC-derived extracellular vesicles were safe and well-tolerated, down-regulated cytokine storms, and restored oxygenation. Thus, they can be considered a promising therapeutic candidate for severe COVID-19.
Methods: The study was carried out in phases I (safety study, 101 patients) and II (efficacy study, 80 patients) in a randomized, double-blind study at four hospital centers from April 2021 to August 2021. In addition to standard treatments, 15 mL of normal saline solution containing 15×109 vesicles was injected intravenously for five consecutive days.
Results: No reaction or adverse events were observed in any patients. In the intervention group, after 5 days of treatment, patients’ clinical status and oxygenation improved, and 75% of patients presented an increased SpO2 after 5 days. Besides, inflammatory parameters assessment indicated a 21% decrease in neutrophil-lymphocyte ratio and a 54% reduction in C-reactive protein after day five of the intervention.
Conclusion: PMSC-derived extracellular vesicles were safe and well-tolerated, down-regulated cytokine storms, and restored oxygenation. Thus, they can be considered a promising therapeutic candidate for severe COVID-19.
Keywords: COVID‐19, Extracellular vesicles, Mesenchymal stromal cell, Placenta-derived mesenchymal stem cell, Acute respiratory distress syndrome
Type of Study: Original |
Subject:
Stem Cell
Received: 2022/10/18 | Accepted: 2022/11/13 | Published: 2022/07/1
Received: 2022/10/18 | Accepted: 2022/11/13 | Published: 2022/07/1
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