Regenerative medicine represents the therapeutic solution of the next future, because will make possible to treat chronic diseases, the most expensive for national healthcare systems, and because it will introduce new treatment more cheap and effective. The main prerogative of regenerative medicine is its multidisciplinary approach, this feature means that, in order to quickly optimize highly innovative marketable products, should be initiated an effective coordinated cooperation between companies and public institution of research, able to bring together different knowledge and technologies. In other countries, more advanced in regenerative medicine (like Germany, Usa and Japan) initiatives at political level are already been taken in order to promote industrial development in this sector.
The decision has been the same, namely to develop centralized infrastructure in order to harmonize necessities and competencies of public and private sector and to manage all the process that starts with research and arrive to the patient’ s bed.
Although it is forecasted that the turnover of this sector will exceed 5 Bn. Us Dollar in 2015, today, in Italy doesn’t exist any National strategy aimed at harmonizing of the many disciplines that underlie regenerative medicine, or the promotion of the same on the territory. The proposed infrastructure under this project (IRMI) will aim to meet the requirement of the strategy, whose main objective is to impose the Italian companies and knowledge in an industry that today begins its “golden age “and that will bring, in the coming years, excellent opportunities for investment and development.
During the first 36 months, tor which the current funds are requested, the “IRMI” intends to create a network of active collaboration among the members of the consortium, launching a process of specialization “all Italian” in the field of Regenerative Medicine, with the ultimate aim of:
- improving the infrastructure for: biobanking, cell manipulation and support to research activities and industrial development of products for adavanced therapy, including translational clinical research;
- offering new opportunities for autologous “Banking” of cells and tissues, with the exception of cord blood;
- to activate and implement a three-year training plan for new professionals figures in the various articultaions of regenerative medicine,
- to place on the market, at the end of the process of research and development:
- - At least four between: decellularized human tissues, osteo-inductive malleable thermoplastic pastes, bone tissue with automated cut and sizing, electro-spun biological membranes, biomatrices and biocompatible polymers;
- - A new product with not relevant manipulation, based on mesenchymal stem cells from the stromal vascular fraction of dipose tissue (Lipostem) for clinical use;
- - At least one product with relevant manipulation based on cultures of epithelial stem cell;
- - At least one cellular orphan drug for the treatment of scleroderma;
- to bring in phase II of clinical trial at least two cellular products with relevant manipulation, based on Lipostem technology as cellular source.
- to bring in phase II clinical trial at least two cellular products with relevant manipulation, based on cultures of epithelial stem cells;
- to bring in phase II clinical trial at least two products of advanced therapy for regeneration of cutaneous lesions;
The activities in paragraphs 4), 5) 6) and 7) will be conducted following a process of development with industrial research, experimental development, validation of results, patenting and production, including also for clinical trials.
- to provide consultancy and research services in outsourcing over the territory, in order to support new companies that want to begin their activities in this area;
- scientific activity of dissemination to the public, of principles and the potential of regenerative medicine.
Due to the high number of groups that have joined IRMI and to the expertise gained, that will guarantee IRMI visibility and attractiveness to new investors and participation in targeted national and international research calls, especially the funding of Horizon 2020, also on the strength of the critical mass resulting from the gathering of the highest Italian expertise in the field. At the end of the first 5 years of operation, it is expected that the IRMI will be able to finance itself, it will not be a burden on the State and also creating new professions, new jobs and promoting scholarships and training courses.
The establishment of IRMI creates the conditionso that the development objectives have a different time horizon with some of them transferable products for the industry over the 36 months of the project and others, whose times of implementation and will be implemented in the medium to long term.1.5