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2018 年在全球获得营销授权的细胞、组织和基因产品。

Cell, tissue and gene products with marketing authorization in 2018 worldwide.

机构信息

Andalusian Initiative for Advanced Therapies, Junta de Andalucía, Seville, Spain; Andalusian Transplant Coordination, Servicio Andaluz de Salud, Seville, Spain.

Sydney Medical School, University of Sydney, Sydney, Australia; Gene and Stem Cell Therapy Program, Centenary Institute, Sydney, Australia; Department of Cell and Molecular Therapies, Royal Prince Alfred Hospital, New South Wales, Australia; International Society for Cell & Gene Therapy (ISCT) President.

出版信息

Cytotherapy. 2018 Nov;20(11):1401-1413. doi: 10.1016/j.jcyt.2018.09.010. Epub 2018 Oct 24.


DOI:10.1016/j.jcyt.2018.09.010
PMID:30366616
Abstract

Cell and gene therapies (CGTs) are progressively entering into clinical practice in different parts of the world. The International Society for Cell & Gene Therapy (ISCT), a global scientific society, has been committed since 1992 to supporting and developing knowledge on clinical applications of CGTs. Considering the number of products that have been progressively approved and, in some cases, withdrawn in recent years, the ISCT would like to present a brief annual report on CGTs with marketing authorization (MA) in different regions. This article reflects the dynamic momentum around authorized CGTs coinciding with the parallel increase of unproven approaches where cells are delivered without appropriate and rigorous scientific and regulatory assessment and authorization. This is intended to be a living document with a yearly update linked to a dedicated section of the ISCT website for faster adjustments. The aim is to ultimately inform, by periodic snapshots, the scientific community, healthcare stakeholders and patient associations on authorized CGT products as a way to increase communication around the approved therapeutic approaches charged with heightened expectations.

摘要

细胞和基因治疗(CGTs)正在世界不同地区逐步进入临床实践。国际细胞与基因治疗学会(ISCT)作为一个全球性的科学学会,自 1992 年以来一直致力于支持和发展 CGTs 的临床应用知识。考虑到近年来已逐步批准并在某些情况下撤回的产品数量,ISCT 希望就不同地区获得营销授权(MA)的 CGT 产品提供一份简要的年度报告。本文反映了在未经证实的方法平行增加的情况下,获得授权的 CGT 所具有的动态势头,这些方法涉及未经适当和严格的科学和监管评估和授权而输送细胞。这旨在成为一份具有年度更新的动态文件,链接到 ISCT 网站的一个专门部分,以便更快速地进行调整。其目的是最终通过定期的快照,向科学界、医疗保健利益相关者和患者协会通报已批准的 CGT 产品,以此增加对批准的治疗方法的沟通,这些方法承载着更高的期望。

相似文献

[1]
Cell, tissue and gene products with marketing authorization in 2018 worldwide.

Cytotherapy. 2018-10-24

[2]
International Society for Cell & Gene Therapy Position Paper: Key considerations to support evidence-based cell and gene therapies and oppose marketing of unproven products.

Cytotherapy. 2023-9

[3]
Current challenges in cell and gene therapy: a joint view from the European Committee of the International Society for Cell & Gene Therapy (ISCT) and the European Society for Blood and Marrow Transplantation (EBMT).

Cytotherapy. 2024-7

[4]
Current state of U.S. Food and Drug Administration regulation for cellular and gene therapy products: potential cures on the horizon.

Cytotherapy. 2019-6-10

[5]
19th Annual Meeting of the Safety Pharmacology Society: regulatory and safety perspectives for advanced therapy medicinal products (cellular and gene therapy products).

Expert Opin Drug Saf. 2020-5

[6]
A Worldwide Overview of Regulatory Frameworks for Tissue-Based Products.

Tissue Eng Part B Rev. 2020-4

[7]
Proceedings of the signature series symposium "cellular therapies for orthopaedics and musculoskeletal disease proven and unproven therapies-promise, facts and fantasy," international society for cellular therapies, montreal, canada, may 2, 2018.

Cytotherapy. 2018-10-10

[8]
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Handb Clin Neurol. 2024

[9]
The Landscape of Cellular and Gene Therapy Products: Authorization, Discontinuations, and Cost.

Hum Gene Ther Clin Dev. 2019-9

[10]
Requirements for Clinical Trials with Gene Therapy and Transplant Products in Switzerland.

Adv Exp Med Biol. 2015

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