Evaluation of the safety and efficacy of using human menstrual blood‐derived mesenchymal stromal cells in treating severe and critically ill COVID‐19 patients: An exploratory clinical trial

The coronavirus disease 2019 (COVID‐19), caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) was identified in December 2019 and has subsequently spread worldwide. Currently, there is no effective method to cure COVID‐19. Mesenchymal stromal cells (MSCs) may be able to effectively...

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Published inClinical and Translational Medicine Vol. 11; no. 2; pp. e297 - n/a
Main Authors Xu, Xiaowei, Jiang, Wanli, Chen, Lijun, Xu, Zhenyu, Zhang, Qiang, Zhu, Mengfei, Ye, Peng, Li, Hang, Yu, Liang, Zhou, Xiaoyang, Zhou, Chenliang, Chen, Xiaobei, Zheng, Xiaoqin, Xu, Kaijin, Cai, Hongliu, Zheng, Shufa, Jiang, Wubian, Wu, Xiaojun, Li, Dong, Chen, Lu, Luo, Qingqing, Wang, Yingyan, Qu, Jingjing, Li, Yifei, Zheng, Wendi, Jiang, Yingan, Tang, Lingling, Xiang, Charlie, Li, Lanjuan
Format Journal Article Web Resource
LanguageEnglish
Published United States John Wiley & Sons, Inc 01.02.2021
John Wiley and Sons Inc
Wiley
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Abstract The coronavirus disease 2019 (COVID‐19), caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) was identified in December 2019 and has subsequently spread worldwide. Currently, there is no effective method to cure COVID‐19. Mesenchymal stromal cells (MSCs) may be able to effectively treat COVID‐19, especially for severe and critical patients. Menstrual blood‐derived MSCs have recently received much attention due to their superior proliferation ability and their lack of ethical problems. Forty‐four patients were enrolled from January to April 2020 in a multicenter, open‐label, nonrandomized, parallel‐controlled exploratory trial. Twenty‐six patients received allogeneic, menstrual blood‐derived MSC therapy, and concomitant medications (experimental group), and 18 patients received only concomitant medications (control group). The experimental group was treated with three infusions totaling 9 × 107 MSCs, one infusion every other day. Primary and secondary endpoints related to safety and efficacy were assessed at various time points during the 1‐month period following MSC infusion. Safety was measured using the frequency of treatment‐related adverse events (AEs). Patients in the MSC group showed significantly lower mortality (7.69% died in the experimental group vs 33.33% in the control group; P = .048). There was a significant improvement in dyspnea while undergoing MSC infusion on days 1, 3, and 5. Additionally, SpO2 was significantly improved following MSC infusion, and chest imaging results were improved in the experimental group in the first month after MSC infusion. The incidence of most AEs did not differ between the groups. MSC‐based therapy may serve as a promising alternative method for treating severe and critical COVID‐19. Menstrual blood‐derived MSC transplantation significantly lowers the mortality of severe and critical SARS‐CoV‐2‐induced COVID‐19. This prospective and systematic report assessed the ability of menstrual blood‐derived MSCs to treat both severe and critically ill COVID‐19 patients. MSC‐based therapy may serve in future clinical applications as an alternative way for the treatment of COVID‐19
AbstractList The coronavirus disease 2019 (COVID‐19), caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) was identified in December 2019 and has subsequently spread worldwide. Currently, there is no effective method to cure COVID‐19. Mesenchymal stromal cells (MSCs) may be able to effectively treat COVID‐19, especially for severe and critical patients. Menstrual blood‐derived MSCs have recently received much attention due to their superior proliferation ability and their lack of ethical problems. Forty‐four patients were enrolled from January to April 2020 in a multicenter, open‐label, nonrandomized, parallel‐controlled exploratory trial. Twenty‐six patients received allogeneic, menstrual blood‐derived MSC therapy, and concomitant medications (experimental group), and 18 patients received only concomitant medications (control group). The experimental group was treated with three infusions totaling 9 × 107 MSCs, one infusion every other day. Primary and secondary endpoints related to safety and efficacy were assessed at various time points during the 1‐month period following MSC infusion. Safety was measured using the frequency of treatment‐related adverse events (AEs). Patients in the MSC group showed significantly lower mortality (7.69% died in the experimental group vs 33.33% in the control group; P = .048). There was a significant improvement in dyspnea while undergoing MSC infusion on days 1, 3, and 5. Additionally, SpO2 was significantly improved following MSC infusion, and chest imaging results were improved in the experimental group in the first month after MSC infusion. The incidence of most AEs did not differ between the groups. MSC‐based therapy may serve as a promising alternative method for treating severe and critical COVID‐19.
The coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified in December 2019 and has subsequently spread worldwide. Currently, there is no effective method to cure COVID-19. Mesenchymal stromal cells (MSCs) may be able to effectively treat COVID-19, especially for severe and critical patients. Menstrual blood-derived MSCs have recently received much attention due to their superior proliferation ability and their lack of ethical problems. Forty-four patients were enrolled from January to April 2020 in a multicenter, open-label, nonrandomized, parallel-controlled exploratory trial. Twenty-six patients received allogeneic, menstrual blood-derived MSC therapy, and concomitant medications (experimental group), and 18 patients received only concomitant medications (control group). The experimental group was treated with three infusions totaling 9 × 107 MSCs, one infusion every other day. Primary and secondary endpoints related to safety and efficacy were assessed at various time points during the 1-month period following MSC infusion. Safety was measured using the frequency of treatment-related adverse events (AEs). Patients in the MSC group showed significantly lower mortality (7.69% died in the experimental group vs 33.33% in the control group; P = .048). There was a significant improvement in dyspnea while undergoing MSC infusion on days 1, 3, and 5. Additionally, SpO2 was significantly improved following MSC infusion, and chest imaging results were improved in the experimental group in the first month after MSC infusion. The incidence of most AEs did not differ between the groups. MSC-based therapy may serve as a promising alternative method for treating severe and critical COVID-19.The coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified in December 2019 and has subsequently spread worldwide. Currently, there is no effective method to cure COVID-19. Mesenchymal stromal cells (MSCs) may be able to effectively treat COVID-19, especially for severe and critical patients. Menstrual blood-derived MSCs have recently received much attention due to their superior proliferation ability and their lack of ethical problems. Forty-four patients were enrolled from January to April 2020 in a multicenter, open-label, nonrandomized, parallel-controlled exploratory trial. Twenty-six patients received allogeneic, menstrual blood-derived MSC therapy, and concomitant medications (experimental group), and 18 patients received only concomitant medications (control group). The experimental group was treated with three infusions totaling 9 × 107 MSCs, one infusion every other day. Primary and secondary endpoints related to safety and efficacy were assessed at various time points during the 1-month period following MSC infusion. Safety was measured using the frequency of treatment-related adverse events (AEs). Patients in the MSC group showed significantly lower mortality (7.69% died in the experimental group vs 33.33% in the control group; P = .048). There was a significant improvement in dyspnea while undergoing MSC infusion on days 1, 3, and 5. Additionally, SpO2 was significantly improved following MSC infusion, and chest imaging results were improved in the experimental group in the first month after MSC infusion. The incidence of most AEs did not differ between the groups. MSC-based therapy may serve as a promising alternative method for treating severe and critical COVID-19.
Abstract The coronavirus disease 2019 (COVID‐19), caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) was identified in December 2019 and has subsequently spread worldwide. Currently, there is no effective method to cure COVID‐19. Mesenchymal stromal cells (MSCs) may be able to effectively treat COVID‐19, especially for severe and critical patients. Menstrual blood‐derived MSCs have recently received much attention due to their superior proliferation ability and their lack of ethical problems. Forty‐four patients were enrolled from January to April 2020 in a multicenter, open‐label, nonrandomized, parallel‐controlled exploratory trial. Twenty‐six patients received allogeneic, menstrual blood‐derived MSC therapy, and concomitant medications (experimental group), and 18 patients received only concomitant medications (control group). The experimental group was treated with three infusions totaling 9 × 10 7 MSCs, one infusion every other day. Primary and secondary endpoints related to safety and efficacy were assessed at various time points during the 1‐month period following MSC infusion. Safety was measured using the frequency of treatment‐related adverse events (AEs). Patients in the MSC group showed significantly lower mortality (7.69% died in the experimental group vs 33.33% in the control group; P  = .048). There was a significant improvement in dyspnea while undergoing MSC infusion on days 1, 3, and 5. Additionally, SpO 2 was significantly improved following MSC infusion, and chest imaging results were improved in the experimental group in the first month after MSC infusion. The incidence of most AEs did not differ between the groups. MSC‐based therapy may serve as a promising alternative method for treating severe and critical COVID‐19.
The coronavirus disease 2019 (COVID‐19), caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) was identified in December 2019 and has subsequently spread worldwide. Currently, there is no effective method to cure COVID‐19. Mesenchymal stromal cells (MSCs) may be able to effectively treat COVID‐19, especially for severe and critical patients. Menstrual blood‐derived MSCs have recently received much attention due to their superior proliferation ability and their lack of ethical problems. Forty‐four patients were enrolled from January to April 2020 in a multicenter, open‐label, nonrandomized, parallel‐controlled exploratory trial. Twenty‐six patients received allogeneic, menstrual blood‐derived MSC therapy, and concomitant medications (experimental group), and 18 patients received only concomitant medications (control group). The experimental group was treated with three infusions totaling 9 × 10 7 MSCs, one infusion every other day. Primary and secondary endpoints related to safety and efficacy were assessed at various time points during the 1‐month period following MSC infusion. Safety was measured using the frequency of treatment‐related adverse events (AEs). Patients in the MSC group showed significantly lower mortality (7.69% died in the experimental group vs 33.33% in the control group; P  = .048). There was a significant improvement in dyspnea while undergoing MSC infusion on days 1, 3, and 5. Additionally, SpO 2 was significantly improved following MSC infusion, and chest imaging results were improved in the experimental group in the first month after MSC infusion. The incidence of most AEs did not differ between the groups. MSC‐based therapy may serve as a promising alternative method for treating severe and critical COVID‐19. Menstrual blood‐derived MSC transplantation significantly lowers the mortality of severe and critical SARS‐CoV‐2‐induced COVID‐19. This prospective and systematic report assessed the ability of menstrual blood‐derived MSCs to treat both severe and critically ill COVID‐19 patients. MSC‐based therapy may serve in future clinical applications as an alternative way for the treatment of COVID‐19
Abstract The coronavirus disease 2019 (COVID‐19), caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) was identified in December 2019 and has subsequently spread worldwide. Currently, there is no effective method to cure COVID‐19. Mesenchymal stromal cells (MSCs) may be able to effectively treat COVID‐19, especially for severe and critical patients. Menstrual blood‐derived MSCs have recently received much attention due to their superior proliferation ability and their lack of ethical problems. Forty‐four patients were enrolled from January to April 2020 in a multicenter, open‐label, nonrandomized, parallel‐controlled exploratory trial. Twenty‐six patients received allogeneic, menstrual blood‐derived MSC therapy, and concomitant medications (experimental group), and 18 patients received only concomitant medications (control group). The experimental group was treated with three infusions totaling 9 × 107 MSCs, one infusion every other day. Primary and secondary endpoints related to safety and efficacy were assessed at various time points during the 1‐month period following MSC infusion. Safety was measured using the frequency of treatment‐related adverse events (AEs). Patients in the MSC group showed significantly lower mortality (7.69% died in the experimental group vs 33.33% in the control group; P = .048). There was a significant improvement in dyspnea while undergoing MSC infusion on days 1, 3, and 5. Additionally, SpO2 was significantly improved following MSC infusion, and chest imaging results were improved in the experimental group in the first month after MSC infusion. The incidence of most AEs did not differ between the groups. MSC‐based therapy may serve as a promising alternative method for treating severe and critical COVID‐19.
The coronavirus disease 2019 (COVID‐19), caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) was identified in December 2019 and has subsequently spread worldwide. Currently, there is no effective method to cure COVID‐19. Mesenchymal stromal cells (MSCs) may be able to effectively treat COVID‐19, especially for severe and critical patients. Menstrual blood‐derived MSCs have recently received much attention due to their superior proliferation ability and their lack of ethical problems. Forty‐four patients were enrolled from January to April 2020 in a multicenter, open‐label, nonrandomized, parallel‐controlled exploratory trial. Twenty‐six patients received allogeneic, menstrual blood‐derived MSC therapy, and concomitant medications (experimental group), and 18 patients received only concomitant medications (control group). The experimental group was treated with three infusions totaling 9 × 107 MSCs, one infusion every other day. Primary and secondary endpoints related to safety and efficacy were assessed at various time points during the 1‐month period following MSC infusion. Safety was measured using the frequency of treatment‐related adverse events (AEs). Patients in the MSC group showed significantly lower mortality (7.69% died in the experimental group vs 33.33% in the control group; P = .048). There was a significant improvement in dyspnea while undergoing MSC infusion on days 1, 3, and 5. Additionally, SpO2 was significantly improved following MSC infusion, and chest imaging results were improved in the experimental group in the first month after MSC infusion. The incidence of most AEs did not differ between the groups. MSC‐based therapy may serve as a promising alternative method for treating severe and critical COVID‐19. Menstrual blood‐derived MSC transplantation significantly lowers the mortality of severe and critical SARS‐CoV‐2‐induced COVID‐19. This prospective and systematic report assessed the ability of menstrual blood‐derived MSCs to treat both severe and critically ill COVID‐19 patients. MSC‐based therapy may serve in future clinical applications as an alternative way for the treatment of COVID‐19
The coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified in December 2019 and has subsequently spread worldwide. Currently, there is no effective method to cure COVID-19. Mesenchymal stromal cells (MSCs) may be able to effectively treat COVID-19, especially for severe and critical patients. Menstrual blood-derived MSCs have recently received much attention due to their superior proliferation ability and their lack of ethical problems. Forty-four patients were enrolled from January to April 2020 in a multicenter, open-label, nonrandomized, parallel-controlled exploratory trial. Twenty-six patients received allogeneic, menstrual blood-derived MSC therapy, and concomitant medications (experimental group), and 18 patients received only concomitant medications (control group). The experimental group was treated with three infusions totaling 9 × 10 MSCs, one infusion every other day. Primary and secondary endpoints related to safety and efficacy were assessed at various time points during the 1-month period following MSC infusion. Safety was measured using the frequency of treatment-related adverse events (AEs). Patients in the MSC group showed significantly lower mortality (7.69% died in the experimental group vs 33.33% in the control group; P = .048). There was a significant improvement in dyspnea while undergoing MSC infusion on days 1, 3, and 5. Additionally, SpO was significantly improved following MSC infusion, and chest imaging results were improved in the experimental group in the first month after MSC infusion. The incidence of most AEs did not differ between the groups. MSC-based therapy may serve as a promising alternative method for treating severe and critical COVID-19.
Author Chen, Xiaobei
Xu, Kaijin
Jiang, Wubian
Tang, Lingling
Li, Lanjuan
Zheng, Shufa
Zhu, Mengfei
Zheng, Xiaoqin
Li, Yifei
Xu, Zhenyu
Chen, Lijun
Xiang, Charlie
Wang, Yingyan
Li, Hang
Zhang, Qiang
Yu, Liang
Zhou, Chenliang
Luo, Qingqing
Cai, Hongliu
Jiang, Wanli
Ye, Peng
Jiang, Yingan
Zhou, Xiaoyang
Li, Dong
Qu, Jingjing
Xu, Xiaowei
Chen, Lu
Wu, Xiaojun
Zheng, Wendi
AuthorAffiliation 5 Department of Respiratory Disease Thoracic Disease Centre The First Affiliated Hospital College of Medicine Zhejiang University Hangzhou Zhejiang P. R. China
1 State Key Laboratory for Diagnosis and Treatment of Infectious Diseases National Clinical Research Center for Infectious Diseases Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases The First Affiliated Hospital College of Medicine Zhejiang University Hangzhou Zhejiang P. R. China
4 Shulan (Hangzhou) Hospital, Zhejiang Shuren University Shulan International Medical College Hangzhou Zhejiang P. R. China
2 Department of Infectious Diseases Renmin Hospital of Wuhan University Wuhan Hebei P.R. China
3 Innovative Precision Medicine (IPM) Group Hangzhou Zhejiang P. R. China
AuthorAffiliation_xml – name: 1 State Key Laboratory for Diagnosis and Treatment of Infectious Diseases National Clinical Research Center for Infectious Diseases Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases The First Affiliated Hospital College of Medicine Zhejiang University Hangzhou Zhejiang P. R. China
– name: 3 Innovative Precision Medicine (IPM) Group Hangzhou Zhejiang P. R. China
– name: 2 Department of Infectious Diseases Renmin Hospital of Wuhan University Wuhan Hebei P.R. China
– name: 5 Department of Respiratory Disease Thoracic Disease Centre The First Affiliated Hospital College of Medicine Zhejiang University Hangzhou Zhejiang P. R. China
– name: 4 Shulan (Hangzhou) Hospital, Zhejiang Shuren University Shulan International Medical College Hangzhou Zhejiang P. R. China
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  givenname: Xiaowei
  surname: Xu
  fullname: Xu, Xiaowei
  organization: Zhejiang University
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  givenname: Wanli
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  organization: Renmin Hospital of Wuhan University
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  givenname: Lijun
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  surname: Chen
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  givenname: Zhenyu
  surname: Xu
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  organization: Innovative Precision Medicine (IPM) Group
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  organization: Innovative Precision Medicine (IPM) Group
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  fullname: Ye, Peng
  organization: Renmin Hospital of Wuhan University
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  surname: Li
  fullname: Li, Hang
  organization: Innovative Precision Medicine (IPM) Group
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  givenname: Liang
  orcidid: 0000-0003-1007-3951
  surname: Yu
  fullname: Yu, Liang
  organization: Zhejiang University
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  givenname: Xiaoyang
  surname: Zhou
  fullname: Zhou, Xiaoyang
  organization: Renmin Hospital of Wuhan University
– sequence: 11
  givenname: Chenliang
  surname: Zhou
  fullname: Zhou, Chenliang
  organization: Renmin Hospital of Wuhan University
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  givenname: Xiaobei
  surname: Chen
  fullname: Chen, Xiaobei
  organization: Renmin Hospital of Wuhan University
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  organization: Zhejiang University
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  organization: Zhejiang University
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  givenname: Hongliu
  surname: Cai
  fullname: Cai, Hongliu
  organization: Zhejiang University
– sequence: 16
  givenname: Shufa
  surname: Zheng
  fullname: Zheng, Shufa
  organization: Zhejiang University
– sequence: 17
  givenname: Wubian
  surname: Jiang
  fullname: Jiang, Wubian
  organization: Renmin Hospital of Wuhan University
– sequence: 18
  givenname: Xiaojun
  surname: Wu
  fullname: Wu, Xiaojun
  organization: Renmin Hospital of Wuhan University
– sequence: 19
  givenname: Dong
  surname: Li
  fullname: Li, Dong
  organization: Renmin Hospital of Wuhan University
– sequence: 20
  givenname: Lu
  surname: Chen
  fullname: Chen, Lu
  organization: Innovative Precision Medicine (IPM) Group
– sequence: 21
  givenname: Qingqing
  surname: Luo
  fullname: Luo, Qingqing
  organization: Innovative Precision Medicine (IPM) Group
– sequence: 22
  givenname: Yingyan
  surname: Wang
  fullname: Wang, Yingyan
  organization: Innovative Precision Medicine (IPM) Group
– sequence: 23
  givenname: Jingjing
  surname: Qu
  fullname: Qu, Jingjing
  organization: Zhejiang University
– sequence: 24
  givenname: Yifei
  surname: Li
  fullname: Li, Yifei
  organization: Zhejiang University
– sequence: 25
  givenname: Wendi
  surname: Zheng
  fullname: Zheng, Wendi
  organization: Zhejiang University
– sequence: 26
  givenname: Yingan
  surname: Jiang
  fullname: Jiang, Yingan
  email: jiangya_cn@aliyun.com
  organization: Renmin Hospital of Wuhan University
– sequence: 27
  givenname: Lingling
  surname: Tang
  fullname: Tang, Lingling
  email: lltang72@126.com
  organization: Shulan (Hangzhou) Hospital, Zhejiang Shuren University Shulan International Medical College
– sequence: 28
  givenname: Charlie
  orcidid: 0000-0002-9193-3900
  surname: Xiang
  fullname: Xiang, Charlie
  email: cxiang@zju.edu.cn
  organization: Zhejiang University
– sequence: 29
  givenname: Lanjuan
  surname: Li
  fullname: Li, Lanjuan
  email: ljli@zju.edu.cn
  organization: Shulan (Hangzhou) Hospital, Zhejiang Shuren University Shulan International Medical College
BackLink https://www.ncbi.nlm.nih.gov/pubmed/33634996$$D View this record in MEDLINE/PubMed
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Keywords safety and efficacy
severe and critical patients
coronavirus disease 2019 (COVID-19)
mesenchymal stromal cells
Language English
License Attribution
2021 The Authors. Clinical and Translational Medicine published by John Wiley & Sons Australia, Ltd on behalf of Shanghai Institute of Clinical Bioinformatics.
This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
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Notes Xiaowei Xu, Wanli Jiang, Lijun Chen, and Zhenyu Xu contributed equally to this manuscript.
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Snippet The coronavirus disease 2019 (COVID‐19), caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) was identified in December 2019 and has...
The coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified in December 2019 and has...
Abstract The coronavirus disease 2019 (COVID‐19), caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) was identified in December 2019 and...
Abstract The coronavirus disease 2019 (COVID‐19), caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) was identified in December 2019 and...
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SubjectTerms Adenoviruses
Adolescent
Adult
Aged
Allografts
Clinical medicine
Clinical trials
coronavirus disease 2019 (COVID‐19)
Coronaviruses
COVID-19 - blood
COVID-19 - mortality
COVID-19 - therapy
COVID-19 vaccines
Critical Illness
Disease transmission
Disease-Free Survival
Dyspnea
Epidemics
Female
Hospitals
Humans
Infections
Male
Medical research
Menstruation
Mesenchymal Stem Cell Transplantation
Mesenchymal Stem Cells
mesenchymal stromal cells
Middle Aged
safety and efficacy
SARS-CoV-2 - metabolism
Severe acute respiratory syndrome coronavirus 2
severe and critical patients
Severity of Illness Index
Stem cells
Survival Rate
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Title Evaluation of the safety and efficacy of using human menstrual blood‐derived mesenchymal stromal cells in treating severe and critically ill COVID‐19 patients: An exploratory clinical trial
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Volume 11
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