P5-6. Good Manufacturing Practice Standard for Manufacturing of Multi-structural Scaffolds for the Treatment of Large Bone Defects
Project leader: Marie-Luise Wille (Science and Engineering Faculty, QUT)
Industry partner: 3D Industries
Objective:
Large segmental bone defects are difficult to treat in conventional ways. Risk of infection and revision surgery likelihood is high.
Currently 8 clinical cases, which were treated with a patient specific bone scaffold to regenerate bone, showed no infection or need for revision surgery needed so far. Bone regrowth has been demonstrated in the patients.
Clinician-Scientist interaction and Bench-to-Bedside translation remains problematic.
Alignment within M3D Innovation:
Development of a multiscale imaging and manufacturing workflow.
Aligns well with plate design fixation project P5-7, biodegradable scaffolds P5-8, and P2-2 Quality Standards for AM parts.
Approach:
Definition of each individual step of the bone scaffold manufacturing process.
Working in close collaborations with clinicians to define shortfalls of the bench to bedside process.
Development of a simplified process from clinical CT data to 3D printable models (without the Materialise Suite).
Optimisation of the overall workflow from CT imaging to 3D printing.
Creation of a scaffold design library suitable for different anatomical locations and surgical approaches.
Key Milestones:
Definition of the key modules of a patient specific bone scaffold design.
Semi-automated process of patient specific bone scaffold design from CT data.