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基于细胞的 2019 冠状病毒病治疗方法:恰当的临床研究至关重要。

Cell-based therapies for coronavirus disease 2019: proper clinical investigations are essential.

机构信息

Laboratory of Nano-Regenerative Medicine, Faculty of Medicine, Universidad de los Andes, Santiago, Chile; Cells for Cells and Consorcio Regenero, Chilean Consortium for Regenerative Medicine, Santiago, Chile.

Laboratory of Pulmonary Investigation, Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil; National Institute of Science and Technology for Regenerative Medicine, Rio de Janeiro, Brazil.

出版信息

Cytotherapy. 2020 Nov;22(11):602-605. doi: 10.1016/j.jcyt.2020.04.089. Epub 2020 Apr 17.

DOI:10.1016/j.jcyt.2020.04.089
PMID:32933835
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7163352/
Abstract

The serious consequences of the global coronavirus disease 2019 (COVID-19) pandemic have prompted a rapid global response to develop effective therapies that can lessen disease severity in infected patients. Cell-based approaches, primarily using mesenchymal stromal cells (MSCs), have demonstrated a strong safety profile and possible efficacy in patients with acute respiratory distress syndrome (ARDS), but whether these therapies are effective for treating respiratory virus-induced ARDS is unknown. According to the World Health Organization International Clinical Trials Registry Platform and the National Institutes of Health ClinicalTrials.gov databases, 27 clinical investigations of MSC-based cell therapy approaches have begun in China since the onset of the COVID-19 outbreak, with a growing number of academic and industry trials elsewhere as well. Several recent published reports have suggested potential efficacy; however, the available data presented are either anecdotal or from incomplete, poorly controlled investigations. Therefore, although there may be a potential role for MSCs and other cell-based therapies in treatment of COVID-19, these need to be investigated in a rationally designed, controlled approach if safety and efficacy are to be demonstrated accurately. The authors urge that the field proceed by finding a balance between swift experimentation and communication of results and scientifically coherent generation and analysis of clinical data.

摘要

全球 2019 年冠状病毒病(COVID-19)大流行的严重后果促使全球迅速做出反应,开发出能够减轻感染患者疾病严重程度的有效疗法。基于细胞的方法主要使用间充质基质细胞(MSCs),在急性呼吸窘迫综合征(ARDS)患者中显示出强大的安全性和可能的疗效,但这些疗法是否对治疗呼吸道病毒引起的 ARDS 有效尚不清楚。根据世界卫生组织国际临床试验注册平台和美国国立卫生研究院 ClinicalTrials.gov 数据库,自 COVID-19 爆发以来,中国已开始进行 27 项基于 MSC 的细胞治疗方法的临床研究,其他地方也有越来越多的学术和行业试验。最近发表的几份报告表明了潜在的疗效;然而,目前提供的数据要么是轶事证据,要么是来自不完全、控制不佳的研究。因此,尽管间充质干细胞和其他基于细胞的疗法在 COVID-19 治疗中可能有一定作用,但如果要准确证明安全性和疗效,就需要以合理设计的对照方法进行研究。作者敦促该领域在快速试验和结果交流与科学一致的临床数据生成和分析之间找到平衡。

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Clinical Study of Mesenchymal Stem Cell Treatment for Acute Respiratory Distress Syndrome Induced by Epidemic Influenza A (H7N9) Infection: A Hint for COVID-19 Treatment.间充质干细胞治疗甲型H7N9流感感染所致急性呼吸窘迫综合征的临床研究:对新型冠状病毒肺炎治疗的启示
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