The goal of this project has been development of an advanced biomaterial approach to bone regeneration based on novel attributes of the polymer, poly(ethyl acrylate) (PEA). This polymer organises adsorbed fibronectin (FN) into a fibrillar conformation, exposing key protein domains relating to cell and growth factor (GF) attachment. This parallel presentation of binding sites and GFs yields a synergistic amplification of cellular response to GFs such as BMP-2. This in turn means a significant reduction in the GF dose required to stimulate effects including osteogenic differentiation. The clinical significance includes provision of a low dose alternative to soluble BMP-2 administration which usually occurs at supraphysiological doses in procedures such as spinal fusion and has been linked to life threatening complications by the FDA.
This PoC project has focussed on characterisation of new PEA coating methods (spray and plasma polymerisation) to minimise the volume of non-degradable PEA used. It has been demonstrated that plasma polymerisation can deposit nanometric layers of PEA, in a cost effective manner, on a variety of 2D and 3D substrates. This coating, used in tandem with FN and BMP-2 this has been shown to stimulate osteogenesis in MSCs in vitro and repair of critical sized bone defects in vivo in a similar way to bulk PEA.
The second focus of the project has been developing a commercial proposition for the bone repair technology yielding discussions with major orthopaedic companies and defining an outline plan for clinical translation. Whilst still in pre-clinical development this technology is producing data which will support application for first-in-man trial. This will be a major inflection point for attracting licence or investment.
