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

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.

The Therapeutic Effect of Mesenchymal Stem Cells in Spinal Cord Injury

“…Subsequently, several phases I/II clinical studies were initiated in Switzerland, Chile, Brazil, China, Egypt, India, Japan, and Korea. These research findings are modest but encouraging [72,73]. However, bigger populations of patients are necessary before making any practical statements, despite the encouraging findings that were attained [74].…”

Research progress of implantation materials and its biological evaluation

“…At present, the quality of TEMPs is mainly controlled from three aspects: materials and scaffolds, components of biotechnology and final products. In general, scaffold materials are evaluated according to ISO 10993 biological evaluation standards for medical devices; The biotechnological components of such products (such as cells and growth factors, etc) should be systematically studied according to the relevant requirements of biological products, and the structure and function of cells [91,92], potential toxicity, and activity of growth factors should be reasonably evaluated. When evaluating the final products, animal models that can simulate the actual use of tissue engineering products are the best way to evaluate them.…”

Narratives, uncertainty and subjectivity in the context of regenerative medicine

“…As Cuende points out, it is essential to distinguish between the authorisation of a clinic to carry out processing methods for autologous biological products in regenerative medicine and the authorisation to use the product, either for research or as a product with proven efficacy and safety. in a broad sense [16]. In the case of PRPs, their regulation is the responsibility of the AEMPs, and the prescriber is responsible for monitoring regulation, traceability, pharmacovigilance and guaranteeing efficacy, even in the absence of highquality clinical trials to support their use.…”