Department of Oral Biology, University at Buffalo, The State University of New York, Buffalo, New York, USA; Cell, Gene and Tissue Engineering Center, University at Buffalo, The State University of New York, Buffalo, New York, USA.
Andalusian Transplant Coordination, Servicio Andaluz de Salud; Sevilla, Spain.
Cytotherapy. 2023 Sep;25(9):920-929. doi: 10.1016/j.jcyt.2023.03.002.
The field of regenerative medicine, including cellular immunotherapies, is on a remarkable growth trajectory. Dozens of cell-, tissue- and gene-based products have received marketing authorization worldwide while hundreds-to-thousands are either in preclinical development or under clinical investigation in phased clinical trials. However, the promise of regenerative therapies has also given rise to a global industry of direct-to-consumer offerings of prematurely commercialized cell and cell-based products with unknown safety and efficacy profiles. Since its inception, the International Society for Cell & Gene Therapy Committee on the Ethics of Cell and Gene Therapy has opposed the premature commercialization of unproven cell- and gene-based interventions and supported the development of evidence-based advanced therapy products. In the present Guide, targeted at International Society for Cell & Gene Therapy members, we analyze this industry, focusing in particular on distinctive features of unproven cell and cell-based products and the use of tokens of scientific legitimacy as persuasive marketing devices. We also provide an overview of reporting mechanisms for patients who believe they have been harmed by administration of unapproved and unproven products and suggest practical strategies to address the direct-to-consumer marketing of such products. Development of this Guide epitomizes our continued support for the ethical and rigorous development of cell and cell-based products with patient safety and therapeutic benefit as guiding principles.
再生医学领域，包括细胞免疫疗法，正处于显著的增长轨道上。全球已有数十种基于细胞、组织和基因的产品获得了市场授权，而数以百计至数千种产品正在临床前开发或在临床试验的不同阶段进行临床研究。然而，再生疗法的前景也催生了一个全球性的行业，即直接面向消费者的细胞和基于细胞的产品的过早商业化，这些产品的安全性和疗效情况未知。自成立以来，国际细胞与基因治疗学会细胞与基因治疗伦理委员会一直反对未经证实的细胞和基于细胞的干预措施的过早商业化，并支持开发基于证据的先进治疗产品。在本指南中，我们针对国际细胞与基因治疗学会的成员进行了分析，特别关注未经证实的细胞和基于细胞的产品的独特特征，以及将科学合法性的象征作为有说服力的营销手段的使用。我们还概述了向认为自己因使用未经批准和未经证实产品而受到伤害的患者提供报告机制的情况，并提出了应对此类产品直接面向消费者营销的实用策略。本指南的制定体现了我们对以患者安全和治疗效益为指导原则的细胞和基于细胞产品的伦理和严格开发的持续支持。
