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

被引：97

作者：

Xu, Xiaowei ^{[1
]}

Jiang, Wanli ^{[2
]}

Chen, Lijun ^{[1
]}

Xu, Zhenyu ^{[3
]}

Zhang, Qiang ^{[3
]}

Zhu, Mengfei ^{[4
]}

Ye, Peng ^{[2
]}

Li, Hang ^{[3
]}

Yu, Liang ^{[1
]}

Zhou, Xiaoyang ^{[2
]}

Zhou, Chenliang ^{[2
]}

Chen, Xiaobei ^{[2
]}

Zheng, Xiaoqin ^{[1
]}

Xu, Kaijin ^{[1
]}

Cai, Hongliu ^{[1
]}

Zheng, Shufa ^{[1
]}

Jiang, Wubian ^{[2
]}

Wu, Xiaojun ^{[2
]}

Li, Dong ^{[2
]}

Chen, Lu ^{[3
]}

Luo, Qingqing ^{[3
]}

Wang, Yingyan ^{[3
]}

Qu, Jingjing ^{[5
]}

Li, Yifei ^{[1
]}

Zheng, Wendi ^{[1
]}

Jiang, Yingan ^{[2
]}

Tang, Lingling ^{[4
]}

Xiang, Charlie ^{[1
]}

Li, Lanjuan ^{[1
,4
]}

机构：

[1] Zhejiang Univ, Affiliated Hosp 1, Natl Clin Res Ctr Infect Dis,Collaborat Innovat C, State Key Lab Diag & Treatment Infect Dis,Coll Me, Hangzhou, Zhejiang, Peoples R China

[2] Wuhan Univ, Dept Infect Dis, Renmin Hosp, Wuhan, Hebei, Peoples R China

[3] Innovat Precis Med IPM Grp, Hangzhou, Zhejiang, Peoples R China

[4] Zhejiang Shuren Univ, Shulan Hangzhou Hosp, Shulan Int Med Coll, Hangzhou, Zhejiang, Peoples R China

[5] Zhejiang Univ, Affiliated Hosp 1, Coll Med, Thorac Dis Ctr, Hangzhou, Zhejiang, Peoples R China

来源：

CLINICAL AND TRANSLATIONAL MEDICINE | 2021年 / 11卷 / 02期

基金：

中国国家自然科学基金;

关键词：

coronavirus disease 2019 (COVID-19); mesenchymal stromal cells; safety and efficacy; severe and critical patients; STEM-CELLS; FIBROSIS; THERAPY; INHIBIT; VACCINE;

D O I：

10.1002/ctm2.297

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页数：24

共 98 条

[1] Potential therapeutic application of mesenchymal stem cell-derived exosomes in SARS-CoV-2 pneumonia [J].