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细胞疗法:类型、监管及临床益处

Cell Therapy: Types, Regulation, and Clinical Benefits.

作者信息

El-Kadiry Abed El-Hakim, Rafei Moutih, Shammaa Riam

机构信息

Laboratory of Thrombosis and Hemostasis, Montreal Heart Institute, Research Center, Montreal, QC, Canada.

Department of Biomedical Sciences, Université de Montréal, Montreal, QC, Canada.

出版信息

Front Med (Lausanne). 2021 Nov 22;8:756029. doi: 10.3389/fmed.2021.756029. eCollection 2021.

Abstract

Cell therapy practices date back to the 19 century and continue to expand on investigational and investment grounds. Cell therapy includes stem cell- and non-stem cell-based, unicellular and multicellular therapies, with different immunophenotypic profiles, isolation techniques, mechanisms of action, and regulatory levels. Following the steps of their predecessor cell therapies that have become established or commercialized, investigational and premarket approval-exempt cell therapies continue to provide patients with promising therapeutic benefits in different disease areas. In this review article, we delineate the vast types of cell therapy, including stem cell-based and non-stem cell-based cell therapies, and create the first-in-literature compilation of the different "multicellular" therapies used in clinical settings. Besides providing the nuts and bolts of FDA policies regulating their use, we discuss the benefits of cell therapies reported in 3 therapeutic areas-regenerative medicine, immune diseases, and cancer. Finally, we contemplate the recent attention shift toward combined therapy approaches, highlighting the factors that render multicellular therapies a more attractive option than their unicellular counterparts.

摘要

细胞治疗实践可追溯到19世纪,并且在研究和投资方面持续发展。细胞治疗包括基于干细胞和非干细胞的、单细胞和多细胞疗法,具有不同的免疫表型特征、分离技术、作用机制和监管水平。继已确立或商业化的前代细胞疗法之后,研究性和免于上市前批准的细胞疗法继续在不同疾病领域为患者提供有前景的治疗益处。在这篇综述文章中,我们描述了细胞治疗的多种类型,包括基于干细胞和非干细胞的细胞疗法,并首次编纂了临床中使用的不同“多细胞”疗法的文献。除了提供美国食品药品监督管理局(FDA)规范其使用的政策要点外,我们还讨论了在再生医学、免疫疾病和癌症这三个治疗领域中报道的细胞疗法的益处。最后,我们思考了近期对联合治疗方法的关注转变,强调了使多细胞疗法比单细胞疗法更具吸引力的因素。

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