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

• Published in: Clinical 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
• Language: English
• Published: United States John Wiley & Sons, Inc 01.02.2021; John Wiley and Sons Inc; Wiley
• Subjects: 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; China; safety and efficacy; severe and critical patients; coronavirus disease 2019 (COVID-19); mesenchymal stromal cells
• ISSN: 2001-1326; 2001-1326
• DOI: 10.1002/ctm2.297

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