Clinical and Translational Medicine (Feb 2021)

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

  • Xiaowei Xu,
  • Wanli Jiang,
  • Lijun Chen,
  • Zhenyu Xu,
  • Qiang Zhang,
  • Mengfei Zhu,
  • Peng Ye,
  • Hang Li,
  • Liang Yu,
  • Xiaoyang Zhou,
  • Chenliang Zhou,
  • Xiaobei Chen,
  • Xiaoqin Zheng,
  • Kaijin Xu,
  • Hongliu Cai,
  • Shufa Zheng,
  • Wubian Jiang,
  • Xiaojun Wu,
  • Dong Li,
  • Lu Chen,
  • Qingqing Luo,
  • Yingyan Wang,
  • Jingjing Qu,
  • Yifei Li,
  • Wendi Zheng,
  • Yingan Jiang,
  • Lingling Tang,
  • Charlie Xiang,
  • Lanjuan Li

DOI
https://doi.org/10.1002/ctm2.297
Journal volume & issue
Vol. 11, no. 2
pp. n/a – n/a

Abstract

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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.

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