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 in | Clinical and Translational Medicine Vol. 11; no. 2; pp. e297 - n/a |
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Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
Format | Journal Article Web Resource |
Language | English |
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United States
John Wiley & Sons, Inc
01.02.2021
John Wiley and Sons Inc Wiley |
Subjects | |
Online Access | Get full text |
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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 |
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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 |
Author_xml | – sequence: 1 givenname: Xiaowei surname: Xu fullname: Xu, Xiaowei organization: Zhejiang University – sequence: 2 givenname: Wanli surname: Jiang fullname: Jiang, Wanli organization: Renmin Hospital of Wuhan University – sequence: 3 givenname: Lijun orcidid: 0000-0001-9374-6466 surname: Chen fullname: Chen, Lijun organization: Zhejiang University – sequence: 4 givenname: Zhenyu surname: Xu fullname: Xu, Zhenyu organization: Innovative Precision Medicine (IPM) Group – sequence: 5 givenname: Qiang surname: Zhang fullname: Zhang, Qiang organization: Innovative Precision Medicine (IPM) Group – sequence: 6 givenname: Mengfei surname: Zhu fullname: Zhu, Mengfei organization: Shulan (Hangzhou) Hospital, Zhejiang Shuren University Shulan International Medical College – sequence: 7 givenname: Peng surname: Ye fullname: Ye, Peng organization: Renmin Hospital of Wuhan University – sequence: 8 givenname: Hang surname: Li fullname: Li, Hang organization: Innovative Precision Medicine (IPM) Group – sequence: 9 givenname: Liang orcidid: 0000-0003-1007-3951 surname: Yu fullname: Yu, Liang organization: Zhejiang University – sequence: 10 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 – sequence: 12 givenname: Xiaobei surname: Chen fullname: Chen, Xiaobei organization: Renmin Hospital of Wuhan University – sequence: 13 givenname: Xiaoqin surname: Zheng fullname: Zheng, Xiaoqin organization: Zhejiang University – sequence: 14 givenname: Kaijin surname: Xu fullname: Xu, Kaijin organization: Zhejiang University – sequence: 15 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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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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