Meeting the Shortage of Human Cells and Tissues: The Andalusian Quality Assurance Programme for Tissue Donation.

Background A quality assurance programme for the tissue donation process was launched in Andalusia in 2020 to facilitate the integration of tissue donation into end-of-life care, and to respond to the growing need for human tissue for therapeutic purposes. The results of this programme are presented here. Methods After identifying the hospital departments in which to intensify the detection of tissue donors, expanding training activities and designing a specific data collection system for possible tissue donors who do not donate their tissues, the results of the donation activity were quantified and the causes of non-donation were analysed by applying the critical pathway for deceased tissue donation methodology. Results After an initial drop in activity, which coincided with the coronavirus pandemic, the number of tissue donors increased by 48.4% in 2022 compared to 2019. From the eligible donors, 83% were actual tissue donors and 71% were utilised donors. The modifiable causes of tissue donation loss, in order of frequency, were family refusal, followed by organisational or logistical issues, failure to notify or failure to identify possible donors, and failure to complete donor evaluation. Conclusion As a result of the collaboration of the various professionals involved in the programme, tissue donation activity has increased remarkably, the potential and effectiveness of the donation process have been evaluated, and areas for improvement have been identified, which we hope will lead to continuous improvement of the process.

El negocio de la medicina regenerativa y las células madre: confusión con implicaciones legales / The regenerative medicine and stem cell business: confusion with legal implications

El auge de la medicina regenerativa y el crecimiento de la oferta de terapias autólogas obtenidas a partir de sangre, células o tejidos de los propios pacientes se ha visto favorecido por la actual disponibilidad de diversos dispositivos comerciales de fácil manejo que permiten la elaboración de los productos y su aplicación dentro de un mismo procedimiento. Independientemente de las dudosas eficacia y seguridad de muchos de los tratamientos que se ofrecen bajo el reclamo de las células madre o la medicina regenerativa, la mayor parte de los centros y de los profesionales que ofrecen estos tratamientos desconocen los requisitos y las implicaciones legales de su uso. Una confusión frecuente consiste en no distinguir entre la autorización que requiere el propio dispositivo, considerado producto sanitario, y la autorización para el uso del producto obtenido, que en general se trata de un medicamento, ya sea de terapia avanzada o no, o de un trasplante. Por otra parte, es frecuente que estos tratamientos tengan un carácter experimental, por lo que su administración en ese caso, además de requerir la evaluación ética correspondiente y la autorización de diversos organismos reguladores, debe ofrecerse de forma gratuita y tras recabar el consentimiento informado del paciente y contratar una póliza de seguros específica. En este artículo se presentan, de forma resumida, los principales requisitos para la aplicación de estos productos biológicos autólogos, con el objetivo de que puedan servir de guía tanto para los profesionales que los prescriben como para aquellos que inspeccionan los centros donde se administran. Por último, se ofrecen algunas recomendaciones para los pacientes. (AU)

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. (AU)

[The regenerative medicine and stem cell business: confusion with legal implications]. / El negocio de la medicina regenerativa y las células madre: confusión con implicaciones legales.

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.

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

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.