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生物制品:细胞治疗和 FDA 批准产品。

Biological Products: Cellular Therapy and FDA Approved Products.

机构信息

Student Research Committee, Department of Tissue Engineering and Applied Cell Sciences, School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Department of Biology, School of Advanced Technologies in Medicine, Islamic Azad University Medical Branch of Tehran, Tehran, Iran.

出版信息

Stem Cell Rev Rep. 2019 Apr;15(2):166-175. doi: 10.1007/s12015-018-9866-1.

DOI:10.1007/s12015-018-9866-1
PMID:30623359
Abstract

The pace of advances in the world of science have created new opportunities and insights that give us new and more understanding of our nature and environment. Among the different fields of science, new medical sciences have drawn a great deal of attention among medical science researchers and the society. The hope for finding treatments for incurable diseases and further improvement of man's health is growing thanks to new medical technologies. Among the novel medical fields that have been extensively covered by medical and academic societies are cell therapy and gene therapy that are categorized under regenerative medicine. The present paper is an attempt to introduce the prospect of a curative cell-based therapy and new cellular and gene therapy drugs that have been recently approved by FDA (food and drug administration). Cellular and gene therapy are two very close fields of regenerative medicine and sciences which their targets and applications can be discussed together. What adds to the importance of this new field of science is the possibility to translate the hope for treatment of incurable diseases into actual treatments. What follows delves deeper into this new field of science and the drugs.

摘要

世界科学的进步步伐创造了新的机会和见解,使我们对自然和环境有了新的、更深入的了解。在不同的科学领域中,新的医学科学引起了医学科学研究人员和社会的极大关注。由于新的医疗技术,人们越来越希望找到治疗不治之症的方法,并进一步改善人类的健康。在医学和学术团体广泛涵盖的新型医学领域中,细胞疗法和基因疗法被归类为再生医学。本文试图介绍基于细胞的治疗方法的前景,以及最近被 FDA(食品和药物管理局)批准的新型细胞和基因治疗药物。细胞和基因治疗是再生医学和科学的两个非常密切的领域,它们的目标和应用可以一起讨论。这个新的科学领域的重要性在于,有可能将治疗不治之症的希望转化为实际的治疗方法。接下来将更深入地探讨这一新的科学领域和药物。

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United States Food and Drug Administration Regulation of Gene and Cell Therapies.美国食品药品监督管理局对基因和细胞疗法的监管
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Promotion of Cell-Based Therapy: Special Focus on the Cooperation of Mesenchymal Stem Cell Therapy and Gene Therapy for Clinical Trial Studies.细胞治疗的推广:特别关注间充质干细胞治疗与基因治疗在临床试验研究中的合作。
Adv Exp Med Biol. 2018;1119:103-118. doi: 10.1007/5584_2018_256.
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CAR-T in the clinic: drive with care.临床中的嵌合抗原受体T细胞疗法:谨慎推进。
Gene Ther. 2018 Jun;25(3):157-161. doi: 10.1038/s41434-018-0023-x. Epub 2018 Jul 1.
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Andexxa--an antidote for apixaban and rivaroxaban.安多昔(Andexxa)——一种用于阿哌沙班和利伐沙班的解毒剂。
E7777免疫原性对复发或难治性皮肤T细胞淋巴瘤成年患者的药代动力学、疗效及安全性的影响。
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Three-Dimensional Printing/Bioprinting and Cellular Therapies for Regenerative Medicine: Current Advances.用于再生医学的三维打印/生物打印与细胞疗法:当前进展
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Biomaterials for in situ cell therapy.用于原位细胞治疗的生物材料。
BMEmat. 2023 Sep;1(3). doi: 10.1002/bmm2.12039. Epub 2023 Jul 19.
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A comprehensive evaluation of dermal fibroblast therapy in clinical trials for treating skin disorders and cosmetic applications: a scoping review.全面评估临床试验中用于治疗皮肤疾病和美容应用的真皮成纤维细胞疗法:范围综述。
Stem Cell Res Ther. 2024 Sep 20;15(1):318. doi: 10.1186/s13287-024-03892-0.
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Study on Preclinical Safety and Toxic Mechanism of Human Umbilical Cord Mesenchymal Stem Cells in F344RG Rats.人脐带间充质干细胞在 F344RG 大鼠体内的临床前安全性及毒性机制研究。
Stem Cell Rev Rep. 2024 Nov;20(8):2236-2252. doi: 10.1007/s12015-024-10780-w. Epub 2024 Sep 7.
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Applications of Stem Cell-Derived Extracellular Vesicles in Nerve Regeneration.干细胞衍生的细胞外囊泡在神经再生中的应用。
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Growth factors and growth factor gene therapies for treating chronic wounds.用于治疗慢性伤口的生长因子及生长因子基因疗法。
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Tisagenlecleucel, an approved anti-CD19 chimeric antigen receptor T-cell therapy for the treatment of leukemia.替沙格赛定,一种已获批准的抗CD19嵌合抗原受体T细胞疗法,用于治疗白血病。
Drugs Today (Barc). 2017 Nov;53(11):597-608. doi: 10.1358/dot.2017.53.11.2725754.