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促进安全有效细胞基产品的合理应用:安达卢西亚再生医学计划。

Promoting the ethical use of safe and effective cell-based products: the Andalusian plan on regenerative medicine.

机构信息

Coordinación Autonómica de Trasplantes de Andalucía, Servicio Andaluz de Salud, Sevilla, Spain.

Coordinación Autonómica de Trasplantes de Andalucía, Servicio Andaluz de Salud, Sevilla, Spain.

出版信息

Cytotherapy. 2020 Dec;22(12):712-717. doi: 10.1016/j.jcyt.2020.07.007. Epub 2020 Aug 30.

Abstract

With regard to regenerative medicine, the expectations generated over the last two decades and the time involved in developing this type of therapies, together with the availability of devices that allow point-of-care treatments through the rapid isolation of cellular or plasma products from patients in the operating theater, represent the perfect breeding ground for the offering of unproven or unregulated therapies on a global scale. A multidisciplinary approach-one based on the collaboration of institutions that, from the perspective of their area of competence, can contribute to reversing this worrying situation-to this problem is essential. It is a priority for local health authorities to take measures that are adapted to the particular situation and regulatory framework of their respective territory. In this article, the authors present the regenerative medicine action plan promoted by the Andalusian Transplant Coordination (i.e., the action plan for the largest region in Spain), highlighting the aspects the authors believe are fundamental to its success. The authors describe, in summary form, the methodology, phases of the plan, actions designed, key collaborators, important milestones achieved and main lessons they have drawn from their experience so that this can serve as an example for other institutions interested in promoting the ethical use of this type of therapy.

摘要

关于再生医学,过去二十年产生的期望以及开发这类疗法所需的时间,再加上可在手术室中通过快速从患者体内分离细胞或血浆产品来实现即时治疗的设备,为在全球范围内提供未经证实或不受监管的疗法创造了绝佳的条件。这种情况令人担忧,必须采取多学科方法,即基于能够从各自专业领域为扭转这一局面做出贡献的机构之间的合作,这一点至关重要。当地卫生当局应优先采取适应各自领土具体情况和监管框架的措施。在本文中,作者提出了由安达卢西亚移植协调机构(即西班牙最大地区的行动计划)推动的再生医学行动计划,强调了作者认为对其成功至关重要的方面。作者简要介绍了该计划的方法、阶段、设计的行动、关键合作伙伴、已取得的重要里程碑以及从经验中吸取的主要教训,以便为其他有兴趣促进这种疗法的伦理使用的机构提供借鉴。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/175b/7456586/912fc54167fe/gr1_lrg.jpg

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