PMID- 33634996
OWN - NLM
STAT- MEDLINE
DCOM- 20210510
LR  - 20240330
IS  - 2001-1326 (Print)
IS  - 2001-1326 (Electronic)
IS  - 2001-1326 (Linking)
VI  - 11
IP  - 2
DP  - 2021 Feb
TI  - 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.
PG  - e297
LID - 10.1002/ctm2.297 [doi]
LID - e297
AB  - 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 x 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.
CI  - (c) 2021 The Authors. Clinical and Translational Medicine published by John Wiley & 
      Sons Australia, Ltd on behalf of Shanghai Institute of Clinical Bioinformatics.
FAU - Xu, Xiaowei
AU  - Xu X
AD  - 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.
FAU - Jiang, Wanli
AU  - Jiang W
AD  - Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, 
      Hebei, P.R. China.
FAU - Chen, Lijun
AU  - Chen L
AUID- ORCID: 0000-0001-9374-6466
AD  - 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.
FAU - Xu, Zhenyu
AU  - Xu Z
AD  - Innovative Precision Medicine (IPM) Group, Hangzhou, Zhejiang, P. R. China.
FAU - Zhang, Qiang
AU  - Zhang Q
AD  - Innovative Precision Medicine (IPM) Group, Hangzhou, Zhejiang, P. R. China.
FAU - Zhu, Mengfei
AU  - Zhu M
AD  - Shulan (Hangzhou) Hospital, Zhejiang Shuren University Shulan International 
      Medical College, Hangzhou, Zhejiang, P. R. China.
FAU - Ye, Peng
AU  - Ye P
AD  - Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, 
      Hebei, P.R. China.
FAU - Li, Hang
AU  - Li H
AD  - Innovative Precision Medicine (IPM) Group, Hangzhou, Zhejiang, P. R. China.
FAU - Yu, Liang
AU  - Yu L
AUID- ORCID: 0000-0003-1007-3951
AD  - 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.
FAU - Zhou, Xiaoyang
AU  - Zhou X
AD  - Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, 
      Hebei, P.R. China.
FAU - Zhou, Chenliang
AU  - Zhou C
AD  - Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, 
      Hebei, P.R. China.
FAU - Chen, Xiaobei
AU  - Chen X
AD  - Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, 
      Hebei, P.R. China.
FAU - Zheng, Xiaoqin
AU  - Zheng X
AD  - 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.
FAU - Xu, Kaijin
AU  - Xu K
AD  - 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.
FAU - Cai, Hongliu
AU  - Cai H
AD  - 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.
FAU - Zheng, Shufa
AU  - Zheng S
AD  - 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.
FAU - Jiang, Wubian
AU  - Jiang W
AD  - Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, 
      Hebei, P.R. China.
FAU - Wu, Xiaojun
AU  - Wu X
AD  - Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, 
      Hebei, P.R. China.
FAU - Li, Dong
AU  - Li D
AD  - Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, 
      Hebei, P.R. China.
FAU - Chen, Lu
AU  - Chen L
AD  - Innovative Precision Medicine (IPM) Group, Hangzhou, Zhejiang, P. R. China.
FAU - Luo, Qingqing
AU  - Luo Q
AD  - Innovative Precision Medicine (IPM) Group, Hangzhou, Zhejiang, P. R. China.
FAU - Wang, Yingyan
AU  - Wang Y
AD  - Innovative Precision Medicine (IPM) Group, Hangzhou, Zhejiang, P. R. China.
FAU - Qu, Jingjing
AU  - Qu J
AD  - Department of Respiratory Disease, Thoracic Disease Centre, The First Affiliated 
      Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, P. R. 
      China.
FAU - Li, Yifei
AU  - Li Y
AD  - 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.
FAU - Zheng, Wendi
AU  - Zheng W
AD  - 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.
FAU - Jiang, Yingan
AU  - Jiang Y
AD  - Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, 
      Hebei, P.R. China.
FAU - Tang, Lingling
AU  - Tang L
AD  - Shulan (Hangzhou) Hospital, Zhejiang Shuren University Shulan International 
      Medical College, Hangzhou, Zhejiang, P. R. China.
FAU - Xiang, Charlie
AU  - Xiang C
AUID- ORCID: 0000-0002-9193-3900
AD  - 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.
FAU - Li, Lanjuan
AU  - Li L
AD  - 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.
AD  - Shulan (Hangzhou) Hospital, Zhejiang Shuren University Shulan International 
      Medical College, Hangzhou, Zhejiang, P. R. China.
LA  - eng
GR  - 2020C03125/the Zhejiang Key Research and Development Program/
GR  - 2020C04016/the Zhejiang Key Research and Development Program/
GR  - 81900563/National Natural Science Foundation of China/
GR  - 81802278/National Natural Science Foundation of China/
GR  - 2018ZX09201002-005/National Science & Technology Major Project 
      "Key New Drug Creation and Manufacturing Program"/
GR  - 2017YFA0105701/National Key R&D Program of China/
GR  - the Independent Task of State Key Laboratory for Diagnosis and Treatment of 
      Infectious Diseases/
GR  - 2017ZX10204401/the National Science and Technology Major Project/
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Transl Med
JT  - Clinical and translational medicine
JID - 101597971
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Allografts
MH  - COVID-19/blood/mortality/*therapy
MH  - Critical Illness
MH  - Disease-Free Survival
MH  - Female
MH  - Humans
MH  - Male
MH  - *Menstruation
MH  - *Mesenchymal Stem Cell Transplantation
MH  - *Mesenchymal Stem Cells
MH  - Middle Aged
MH  - SARS-CoV-2/*metabolism
MH  - Severity of Illness Index
MH  - Survival Rate
PMC - PMC7839959
OTO - NOTNLM
OT  - coronavirus disease 2019 (COVID-19)
OT  - mesenchymal stromal cells
OT  - safety and efficacy
OT  - severe and critical patients
COIS- The authors declare that they have no competing interests.
EDAT- 2021/02/27 06:00
MHDA- 2021/02/27 06:01
PMCR- 2021/01/27
CRDT- 2021/02/26 08:38
PHST- 2020/08/17 00:00 [received]
PHST- 2021/01/07 00:00 [revised]
PHST- 2021/01/11 00:00 [accepted]
PHST- 2021/02/26 08:38 [entrez]
PHST- 2021/02/27 06:00 [pubmed]
PHST- 2021/02/27 06:01 [medline]
PHST- 2021/01/27 00:00 [pmc-release]
AID - CTM2297 [pii]
AID - 10.1002/ctm2.297 [doi]
PST - ppublish
SO  - Clin Transl Med. 2021 Feb;11(2):e297. doi: 10.1002/ctm2.297.