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异体间充质干/基质细胞及其他细胞疗法的同种反应性:简明综述

英文原题:Alloreactivity of Allogeneic Mesenchymal Stem/Stromal Cells and Other Cellular Therapies: A Concise Review.

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Alloreactivity of Allogeneic Mesenchymal Stem/Stromal Cells and Other Cellular Therapies: A Concise Review.

PubMed 2022/03/09(内容时间) Stem Cells Int Q3 · IF 3.6(JCR 2025)

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中文摘要

细胞疗法被视为活体药物,为治疗以往无法治愈的疾病(如癌症和骨关节炎等退行性疾病)带来了一波新一代生物疗法。这些细胞疗法在临床研究中获得了显著认可。2017年,美国食品药品监督管理局(FDA)、欧洲药品管理局(EMA)、澳大利亚治疗用品管理局(TGA)以及许多国家的监管机构批准了CAR-T 细胞疗法用于治疗血液系统恶性肿瘤,进一步推动了该领域的发展。另一个里程碑是2018年EMA批准了基于异体间充质干细胞(MSC)的疗法用于治疗克罗恩病。尤其是异体供体来源的MSC疗法,因其“即用型”的可及性,为需要紧急治疗的患者带来了巨大希望和真实期盼。迄今为止,已有数千项临床试验探索了自体与异体细胞疗法的安全性和有效性,认为其是安全的,但有效性程度不一。在当前的大流行中,世界许多地区已开始临床试验,使用MSC治疗重症COVID病例。

然而,目前尚未充分解决组织排斥风险以及因异体细胞的同种异体反应性而产生不良效应的风险。因此,这需要临床研究人员对此类事件进行仔细调查和详细报告。本综述旨在讨论已获批异体MSC及其他几种细胞疗法的当前格局。

我们探讨了报告的任何可能的反应性,以告知读者任何安全问题以及此类疗法的疗效。

展开英文摘要原文

Cellular therapies, deemed live medicine, have brought a wave of new generation biological therapies to treat previously untreatable diseases such as cancers and degenerative diseases like osteoarthritis. These cellular therapies have gained significant recognition in clinical research. The area has been further strengthened with the approval of Chimeric Antigen Receptor added on T cells (CAR-T) therapies by the regulatory authorities USA's Food and Drugs Administration (FDA), European Medical Agency (EMA), the Australian Therapeutic Goods Administration (TGA), and in many countries in 2017 to treat hematological cancers.

Another milestone was achieved when allogeneic Mesenchymal Stem Cell- (MSC-) based therapy was approved by the EMA to treat Chrohn's disease in 2018. Allogeneic donor-derived MSC therapies in particular hold great promise and real hope because of their 'off-the shelf' availability and accessibility for patients in need of urgent treatment.

So far, thousands of clinical trials have explored the safety and efficacy of both autologous and allogeneic cell therapies, deeming them safe, however with varying degrees of efficacy. In the current pandemic, clinical trials have begun in many parts of the world to treat severe cases of COVID with MSCs.

However, the risk of tissue rejection and the development of undesirable effects due to alloreactivity of allogeneic cells are currently not adequately addressed.

Therefore, this warrants careful investigation and detailed reporting of such events by clinical researchers. This review aims at discussing the current landscape of approved allogeneic MSCs along with a few other cellular therapies.

We explore any possible reactivity reported to inform the readers of any safety concern and on the efficacy of such therapies.

论文信息

作者
Shah K、Shah N、Ghassemi F、Ly C、George T、Lutz C、Sumer H
第一作者单位
Magellan Stem Cells P/L, Box Hill, Victoria, Australia.Australia
通讯作者单位
Department of Chemistry and Biotechnology, School of Science, Computing and Engineering Technologies, Swinburne University of Technology, Hawthorn, Victoria, Australia.Australia
文献类型
综述
期刊
Stem cells international2022
原文标识
PubMed 35308830 · DOI 10.1155/2022/9589600