Abstract

Autograft is still playing the role of gold standard in critical sized and non-union bone defects in oral, maxillofacial and orthopaedic surgeries: adequate bone substitutes for remodelling of native bone tissue are a goal yet to achieve. Such bone scaffolds should ensure mechanical stability and strength while their intimate structure should have an adequate interconnected porous network for cells and vessels proliferation. In this framework IBI S/A applied a typical engineering method, developing a bottom-up solution, based on a multi-scale approach: healthy human bone microstructure was understood and mimicked in order to obtain the same macroscopic properties. IBI technology, born from research, was then scaled-up to industrial production. Indeed, a composite solution, bearing cues from both mineral components and polymeric ones, was followed to develop a new three-dimensional bone scaffold, briefly: a bovine derived mineral matrix is reinforced with biodegradable polymers and bioactive agents through a specific nano-emulsion proprietary bath. The bovine derived matrix allows maintaining an adequate 3D-structure and porosity; biopolymers permit to achieve good mechanical properties while bioactive agents promote cell adhesion and proliferation. 

Microstructure, evaluated by E/SEM and micro-CT scans, confirmed a strong resemblance with human cortical bone in terms of open mid-sized porosity. Compression tests evidenced a maximum stress capability (20MPa av.) and a Young’s modulus (0.2GPa av.) comparable with human ones. Further mechanical investigations showed easy shaping by common surgical instruments and high resistance to screws and fixation manoeuvres, thus being feasible to replicate and replace various bone defects. Biological and histological investigations showed scaffolds to be promising substrates for cell adhesion and growth: biocompatibility and cell viability were positively assessed in vitro with standard line cells and on reference animal models. Human adipose tissue derived mesenchymal stem cells were also tested and data showed capability to properly colonize the scaffold and, once induced, to differentiate. Clinical studies are presently undergoing. Collected data confirm the applicability of this novel composite bone substitute. 

Caring at safety as much as at innovation, bone scaffolds were designed according to most strict and severe quality standards and nowadays they’re produced according to GMP standards, applying only human-use approved components. CE marking is under request as a Class III Medical Device. 

IBI S/A is now following the same research & development approach to address the growing need of cartilage substitutes. Micro porous fibres are now under investigation for being used to build flat elastic meshes resembling natural cartilage extracellular structure.