RT Journal Article
T1 [The regenerative medicine and stem cell business: confusion with legal implications].
T2 El negocio de la medicina regenerativa y las células madre: confusión con implicaciones legales.
A1 Cuende, Natividad
A1 Álvarez-Márquez, Antonia José
A1 Díaz-Aunión, Concepción
A1 Castro, Pablo
A1 Huet, Jesús
A1 Pérez-Villares, José Miguel
K1 Biosafety
K1 Bioseguridad
K1 Cell therapy
K1 Comercialización de productos
K1 Consumer product safety
K1 Células madre
K1 Derecho sanitario
K1 Health law
K1 Medicina regenerativa
K1 Plasma rico en plaquetas
K1 Platelet-rich plasma
K1 Products commerce
K1 Regenerative medicine
K1 Seguridad de productos para el consumidor
K1 Stem cells
K1 Terapia celular
AB The rise of regenerative medicine and the growth of the offer of autologous therapies, obtained from blood, cells or tissues of the patients, have been favoured by the current availability of an increasing number of commercial devices. Most of these devices are easy to use, allowing the elaboration of products and its application within the same procedure. Regardless of the questionable efficacy and safety of many of the treatments offered under the claim of stem cells or regenerative medicine, most of the centres and professionals offering these treatments are unaware of the legal requirements and implications of their use. A common confusion consists in not distinguishing between the authorization required by the equipment itself, considered a medical device, and the authorization for the use of the product obtained, usually considered a medicinal product (whether advanced therapy or not) or a transplant. Moreover, these treatments frequently have an experimental nature. In that case, in addition to requiring the corresponding ethical evaluation and the authorization of various regulatory bodies, their administration must be offered free of charge, obtaining the patient's informed consent and after contracting a specific insurance policy. In this article we present a brief summary of the main requirements for the application of these autologous biological products with the aim of serving as a guide both for the professionals who prescribe them and for those who inspect the centres where the products are administered. Finally, we include some recommendations for patients.
YR 2020
FD 2020-03-09
LK http://hdl.handle.net/10668/15234
UL http://hdl.handle.net/10668/15234
LA es
DS RISalud
RD Apr 10, 2025