间充质干细胞治疗新型冠状病毒肺炎研究进展及相关临床试验难点

Mesenchymal stem cells in the treatment of COVID-19— progress and challenges

摘要:

当前新型冠状病毒肆虐，全球确诊患者超过3 500万例，累计死亡患者超过50万例，对于突发疫情，临床尚缺乏有效特异性治疗，新型冠状病毒已成为危害人类健康、社会发展的主要公共卫生问题。间充质干细胞具有抗炎和免疫调节功能，可降低重症患者体内由冠状病毒引发的细胞因子风暴，改善患者肺部纤维化，促进损伤肺组织修复，有望降低新冠肺炎的死亡率。目前已开展多项间充质干细胞治疗新型冠状病毒肺炎临床试验，初步证实了间充质干细胞应用在新冠肺炎方面的安全及有效性。在间充质干细胞治疗新冠肺炎取得进展的同期，还应看到该疗法独有特点及疫情严峻形势对临床试验开和及评价带来的问题与挑战，包括临床试验方案设计、干细胞质量管理以及治疗中的伦理考量。只有对其加以重视，才能保证在严峻疫情下安全有效地开展间充质干细胞治疗新型冠状病毒肺炎的临床试验。

Abstract:

At present, SARS-CoV-2 is raging, and novel coronavirus pneumonia (COVID-19) has caused more than 35 million confirmed patients and more than 500 000 cases death, which seriously endanger human health, socioeconomic development, as well as global medical and public health systems. COVID-19 is highly contagious, has a long incubation period, and causes many death cases due to lack of effective specific treatment. Mesenchymal stem cells have powerful anti-inflammatory and immunoregulatory functions, and can effectively reduce the cytokine storm caused by coronavirus in patients, and improve the pulmonary fibrosis of patients, promote the repair of damaged lung tissue, and reduce the mortality. Currently, a number of related clinical trials of mesenchymal stem cell treatment of COVID-19 have been conducted, and have confirmed the safety and efficacy, suggesting a good clinical application prospect. While progress has been made in mesenchymal stem cell therapy for COVID-19, we should also catch sight of the problems and challenges faced by mesenchymal stem cell clinical trials under severe epidemic situation, including clinical trials design, stem cell quality management, and ethics in treatment. Only by paying attention to these can we guarantee the safe and effective development of mesenchymal stem cell clinical trials in the treatment of COVID-19.