Approach
The SBR project brought together experts from medicine, biochemical, pharmaceutical and material sciences, engineering and industry for solving an unmet challenge in the management of bone loss and bone repair. The consortium focused on the development of a novel technology for bone defect restoration and non-union treatment by designing smart regeneration implants integrated with ex-theatre and in-theatre manufacturing technologies. The bone defect model had been chosen as it represented a challenging clinical condition, associated with lengthy treatment, increased health care cost and re-interventions.
The SBR solution involved 3D-printed polymer parts enriched with electrospun fibers that could be customised according to the individual patient’s physiology, pathology and gender. The framework design would ensure easy placement and include adjustable sensors for post-operative monitoring of e.g. pressure, pH value and temperature. Thus, the smart implant aimed at providing vital information of implant performance in terms of bone growth and infection/inflammation. Within the project lifetime of five years, the in-vivo proof of concept of the SBR solution was tested in preclinical studies. In the long term, the innovation was projected to be used in isolation during fracture fixation and become a platform technology for bone conditions at different anatomical sites, including the jaw, spine and pelvis.
In the course of the project lifetime, SBR ambitioned:
- Establishing the ideal specifications of the SBR implant using digital image modelling of long bones
- Fabricating a host matrix for the active materials using electrospinning
- Evaluating the suitability of the respective technologies and materials for scale-up
- Developing and producing AAV vectors expressing reporter genes or growth factors and optimising delivery systems for controlled release of bioactive agents
- Developing a biosensor to monitor the bone repair processes and evolution of healing
- Evaluating the safety, biocompatibility and effectiveness of the implant device in preclinical in vitro and in vivo studies