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The Coronavirus Pandemic: A Pitfall or a Fast Track for Validating Cell Therapy Products?
Stem Cells and Development ( IF 2.5 ) Pub Date : 2021-01-27 , DOI: 10.1089/scd.2020.0122
maroun khoury 1, 2 , Laertis Ikonomou 3 , massimo Dominici 4 , Katarina Le Blanc 5 , Bruce L Levine 6 , Dan J Weiss 7
Affiliation  

The global COVID-19 pandemic has prompted urgent need for potential therapies for severe respiratory consequences resulting from coronavirus infection. New therapeutic agents that will attenuate ongoing inflammation and at the same time promote regeneration of injured lung epithelial cells are urgently needed. Cell-based therapies, primarily involving mesenchymal stromal cells (MSCs) and their derivatives, are currently investigated worldwide for SARS-CoV-2–induced lung diseases. A significant number of academic centers and companies globally have already initiated such trials. However, at a time of unprecedented need, it is also foreseen that families and caregivers will seek all available options, including access to cell-based and other investigational products, even before proven safety and efficacy as well as regulatory approval. This should not be an excuse for opportunists to sell or advertise unproven therapies of any kind. “Compassionate use” should be conducted in the context of a clinical investigation framed by strict ethical and regulatory permissions, with the goal of obtaining mechanistic information wherever possible.

中文翻译:

冠状病毒大流行:验证细胞疗法产品的陷阱还是捷径?

全球COVID-19大流行促使人们迫切需要针对因冠状病毒感染而导致的严重呼吸道后果的潜在疗法。迫切需要能够减轻正在进行的炎症并同时促进受伤的肺上皮细胞再生的新治疗剂。基于细胞的疗法,主要涉及间充质基质细胞(MSCs)及其衍生物,目前在全球范围内针对SARS-CoV-2诱导的肺部疾病进行了研究。全球许多学术中心和公司已经开始进行此类试验。但是,在前所未有的需求之际,还可以预见,即使在经过验证的安全性和有效性以及监管批准之前,家庭和看护者也将寻求所有可用的选择,包括使用基于细胞的产品和其他研究产品。这不应成为机会主义者出售或宣传任何未经证实的疗法的借口。“同情使用”应在严格的伦理和法规许可下进行的临床研究中进行,以尽可能获取机械信息为目标。
更新日期:2021-01-28
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