Author: 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
Title: Evaluation of the safety and efficacy of using human menstrual bloodâ€derived mesenchymal stromal cells in treating severe and critically ill COVIDâ€19 patients: An exploratory clinical trial Cord-id: 9wsf7fi9 Document date: 2021_1_27
ID: 9wsf7fi9
Snippet: The coronavirus disease 2019 (COVIDâ€19), caused by severe acute respiratory syndrome coronavirus 2 (SARSâ€CoVâ€2) was identified in December 2019 and has subsequently spread worldwide. Currently, there is no effective method to cure COVIDâ€19. Mesenchymal stromal cells (MSCs) may be able to effectively treat COVIDâ€19, especially for severe and critical patients. Menstrual bloodâ€derived MSCs have recently received much attention due to their superior proliferation ability and their lack
Document: The coronavirus disease 2019 (COVIDâ€19), caused by severe acute respiratory syndrome coronavirus 2 (SARSâ€CoVâ€2) was identified in December 2019 and has subsequently spread worldwide. Currently, there is no effective method to cure COVIDâ€19. Mesenchymal stromal cells (MSCs) may be able to effectively treat COVIDâ€19, especially for severe and critical patients. Menstrual bloodâ€derived MSCs have recently received much attention due to their superior proliferation ability and their lack of ethical problems. Fortyâ€four patients were enrolled from January to April 2020 in a multicenter, openâ€label, nonrandomized, parallelâ€controlled exploratory trial. Twentyâ€six patients received allogeneic, menstrual bloodâ€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 1â€month period following MSC infusion. Safety was measured using the frequency of treatmentâ€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. MSCâ€based therapy may serve as a promising alternative method for treating severe and critical COVIDâ€19.
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