The BIOHYBRID Project is implemented by a consortium of ten partners from six state members of the European Union (3 partners from Germany, 2 from Israel, 2 from Portugal, 1 from Spain, 1 from Sweden, 1 from Italy). All the partners have strong experience in the different fields related to the project objectives and steps. Most of the BIOHYBRID partners have long experience in carrying out R&D projects in multidisciplinary and international contexts, have previously developed substantial collaborations between them, and also with leading research centers in Canada and the USA.
Since the BIOHYBRID project addresses a complex neurobiological and technological problem, the development of new tools and devices for the improved regenerative treatment of severe nerve injuries, the joined project partners hold knowledge in complementary domains, mainly biomaterials, neurobiology and clinical surgery.
The seven academic research groups of the consortium possess large experience in the field of nerve regeneration, and combined they will be able to achieve the large amount of state-of-the-art research work, both in vitro and in vivo experimental work, needed to develop and assess the biohybrid nerve device at the preclinical level. In addition, four of the partners have among their members outstanding clinicians with specialisation in microsurgical nerve repair, which together will survey the experimental phases of the project, and define the conditions and setting for clinical trials and application.
The BIOHYBRID consortium has also three SMEs that bring complementary products as the bases for the biohybrid nerve graft and will be highly engaged to promote the new advanced tools from the preclinical research to the clinical application and the market. All three SMEs involved in the project are fully devoted to the development and marketing of medical devices of many designs and functionalities, with focus on regenerative and reparative medicine. The companies utilise novel, proprietary technologies to produce most advanced medical implants that guarantee highest quality, safety and performance to patients. Such industrial involvement will ensure the exploitation of the results. Briefly, the individual roles of the SMEs include for NVR: a) functionalisation/conjugation of hollow tubular devices and nanoparticles, respectively, with neurotrophic factors, b) the in vitro analysis of bioactive matrices/scaffolds using slices or dissociated cell cultures of dorsal root ganglia, and c) evaluation of the remyelination process in co-cultures of dissociated neurons and glial cells, and d) in vivo tests of tubular devices. The main roles of MEDOVENT include: development and manufacture of chitosan-based devices displaying diverse designs and functionalities, b) analysis of the nerve repair devices in regulatory-related biocompatibility tests, c) evaluation of device prototypes in a large gap rabbit model, and d) regulatory-related documentation and preparation of clinical studies. The contribution of ALTA is focused on: a) development of processes to manufacture a chitosan that is optimised for nerve regeneration in terms of molecular weight and degree of acetylation which both define the mechanical strength (elasticity, radial compression strength), biocompatibility (particularly cell adhesion and growth) and biodegradation properties of a chitosan-based nerve guides, b) development of chitosan gels as scaffolds (ALTA has experiences with chitosan gels for wound application), and c) development of coatings for chitosan nerve guides.
According to the call, the integration of SMEs is an important condition, and in the BIOHYBRID project >45% of the EU contribution budget is going to SMEs. The SMEs will therefore have an important role in decision making and controlling technical issues in the project. On another hand, they will benefit along the project from the substantial expertise and research work brought by the academic partners.
Finally, Martin Hildebrandt (MED-TUM), who crucially contributed to ATMP development at MHH, and the SMEs have substantiated expertises to meet the regulatory work for ATMP development.