This project and its results represent a proof of concept for an innovative approach to developing Treg cell therapies, adopting a unique strategy that overcomes many constraints associated with conventional protocols.
High Clinical Impact: The success of this project is crucial for demonstrating the efficacy of allogeneic Treg cell therapy in human immune-mediated diseases. Restoring immune homeostasis through thyTreg immunotherapy could not only resolve the inflammatory processes underlying these diseases but also allow the recovery of patients' natural immune tolerance. This could reduce or eliminate the need for immunosuppressive or biological treatments, establishing a new paradigm in clinical management. Furthermore, the development of a "ready-to-use" cell therapy that does not require individualized autologous production for each patient and can be used without HLA compatibility offers significant potential for treating a wide range of immunity-related diseases, such as autoimmune disorders, which affect millions of people. This strategy, where a production center provides hundreds of doses, would facilitate the broader adoption of the therapy by healthcare institutions.
High Scientific Impact: Over the past decade, the innovative nature and importance of this research line have led to the publication of its results in highly recognized scientific journals. The scientific impact of a new clinical application of these results is expected to be even greater, given the pioneering nature of the project, potentially leading to high-impact publications. The multidisciplinary nature of the project, addressing immunological aspects, immune-mediated processes, and improvements in patients' quality of life, also suggests a high degree of dissemination at scientific congresses.
High Economic Impact: The significance of this trial extends beyond clinical implications to include the costs to national health systems and the impact of innovation on national economic growth. In 2023, the average annual cost of immunosuppressive therapies and biological drugs for patients affected by these diseases was approximately €7,000 per patient, excluding costs related to side effects, and these treatments must be administered chronically. In contrast, the estimated cost of thyTreg therapy involves a single payment of around €13,000 per processed thymus, from which dozens of therapeutic doses could be generated for allogeneic use, potentially treating multiple adult patients. Preliminary evidence from our autologous trial suggests that the benefits of a single dose of thyTreg can last for several years. Therefore, Treg cell immunotherapy for patients with autoimmune processes could become a cost-effective practice for national health systems. Additionally, as a pioneering global project, the technology developed here is likely to have commercial potential and could be exported to other national and international centers, generating economic returns. While the monetary quantification of the impact of this therapy is challenging, its benefits in terms of quality of life and its potential advantages for transplanted patients underscore its significant relevance to healthcare systems.
