Project: In-Situ formed Biomimetic Biomaterial for Bone Regeneration

The field of biomaterials for bone regeneration is advancing rapidly. Because of the risks associated to auto and allogeneic bone grafts, biomaterials are likely to have an increasingly important role in reconstructive skeletal surgery and especially in oral and maxillofacial surgery. In fact, in 2008, in spite of the global economic recession, the combined European market for dental Bone Graft Substitutes (BGS) increased by 12.9% over 2007 and will exceed €300 million by 2015._x000D_ _x000D_ Osteogenesis, that is, the formation of new bone, is a natural repair mechanism that occurs in the human body. However, there are some critical sized defects above which bone tissue will not regenerate itself and need clinical repair. The vast majority of marketed bone graft substitutes are based on non-living inorganic materials. The clinical and biological properties of these materials are unfortunately far from being optimal. Their manipulation and handling is difficult for the clinician and sometimes uncomfortable for the patients and the osteoconductive properties are somehow limited if growth factors driving cell chemotaxis, proliferation and differentiation are not present._x000D_ _x000D_ In this project, Biotechnology Institute ImasD (BTI ImasD), the biomedical and biotechnological SME at the forefront in the design and manufacture of dental implants, prosthetic components and surgical instruments, with the help of BioEngineering Laboratories S.p.A. (BEL), an Italian biotechnological SME expert in the design, development, manufacture and marketing of medical devices, and the Instituto Ortopedico Galeazzi, a reference hospital in Europe for orthopaedics and dentistry, aims to open a new and complementary field of research by designing, developing, evaluating and finally introducing into the market a new in-situ formed biomimetic biomaterial (IS•BioBone) for bone regeneration. The new biomaterial will mimic the natural bone’s composition while promoting physiological bone regeneration process by combining in-situ a pro-active composite with an autologous and biomimetic platelet-fibrin matrix rich in growth factors developed by BTI ImasD. The latter is prepared from patient’s plasma after a simple centrifugation process and promotes tissue regeneration. BTI ImasD will develop the technological process to design and produce a pro-active composite of hydroxyapatite (HA) and reactive type I collagen. By combining both materials, it is feasible to increase osteoblast differentiation, accelerate osteogenesis and improve the osteoconductive and mechanical properties when compared to that of the individual components. This pro-active composite will provide the best microenvironment for the bone-forming cells but also an ideal complement for its interaction with the platelet-fibrin scaffold. In fact, this interaction will be based on the platelet binding properties of the von Willebrand factor present in the collagen and mediated via the Glycoprotein Ib-IX-V complex. The latter constitutes one major innovative breakthrough of this project and a distinguishing property of this biomaterial which will drive its scientific development, marketing approach and market penetration strategy. _x000D_ _x000D_ The IS•BioBone is a structural and biologically active scaffold designed to facilitate the handling, manipulation and administration and to promote faster bone regeneration compared with other products on the market. The IS•BioBone will be ready for commercialization and use in 2014, just when the market of BGS is expected to recover from the global economic recession and return to strong growth. This new biomaterial is intended to provoke a revolution on the market of BGS and fulfill the current demands of the sector. The strong consortium between BTI ImasD, BEL and the Instituto Galeazzi will ensure the execution and success of the proposal. The involvement of BEL and Galeazzi will be of paramount importance to complete the multicentric prospective study that evaluates the safety and bone regeneration potential of IS•BioBone. BEL will have a major role both in managing the administrative protocols related to the biomaterial introduction in the Italian market and in dealing with the needed certifications for the in vivo study and the clinical trial. Galeazzi will be crucial in diffusing the basic, animal and scientific data of the biomaterial in different scientific and dental events across Europe and facilitating its market penetration. BTI ImasD has a complete network of diffusion and education programs on dentistry and oral implantology across Europe which may further help to introduce the new product on the market. It is expected to create a biomaterial department inside the SME which will be in charge of the design and fabrication of the IS•BioBone family of Bone Graft Substitutes. In summary, the tailored biological properties of the new IS•BioBone will help to improve the everyday life of dental patients world-wide and facilitate the activity of the clinicians.

Acronym IS•BioBone (Reference Number: 5210)
Duration 01/03/2010 - 31/03/2015
Project Topic The CO objective of the present proposal is to open a new and complementary field of research by designing, developing, evaluating, translating into an in-patient trial and finally into the market a new in-situ formed biomimetic biomaterial for bone regeneration.
Project Results
(after finalisation)
Bioengineering Laboratories S.p.A. (BEL) participated the phase of in vivo evaluation (rabbit model) of the performances of a novel biomaterial developed by the CO P of the project (the Spanish BTI Biotechnology Institute). Therefore, the CO (and actually unique) result of the project for BEL was an increase in the knowledge of the potentialities of the new biomaterial (a combination of a ceramic with autologous platelet-enriched plasma) in the field of bone regeneration.
Network Eurostars
Call Eurostars Cut-Off 3

Project partner

Number Name Role Country
3 BioEngineering Laboratories S.p.A. Partner Italy
3 IRCCS ISTITUTO ORTOPEDICO GALEAZZI Partner Italy
3 BTI I MAS D S.L. Coordinator Spain