Innovative manufacturing of decellularised bone scaffolds

Bone grafting is the second most common tissue transplantation and is used in a range of clinical procedures from fusing bones together to securing surgical implants. However, due to an immune response to the donor's cellular material, commonly used allograft bone grafts have been found to re-vascularise poorly and have inadequate bone remodelling, leading to incidences of fracture and non-union. Decellularisation of bone tissue has been proposed as a potential solution to these problems. A cost-effectiveness analysis of decellularised bone allograft compared with fresh-frozen bone allograft for acetabular impaction bone grafting during a revision hip arthroplasty concluded that the current six week, labour intensive decellularisation processing of allograft bone is not cost effective and despite providing higher patient benefit, requires cost reduction through innovative manufacturing. This thesis investigates the designing, manufacturing and testing of an automated decellularisation system to optimise the decellularisation process and produce cost-effective bone grafts. Prototype automated decellularisation systems were designed, manufactured and tested in comparison with the current manual decellularisation method. The automated systems decellularised both porcine and human tissue with comparable decellularisation results to the manual method after both biological and mechanical characterisation. Further, the decellularisation process was successfully reduced from six weeks to 13 days using the prototype systems. The automated decellularisation system is now ready to be provided to the NHS Blood and Transplant, Tissue and Eye Services research and development team and to be adopted for use in university research laboratories. The automated decellularisation system can also be used to continue the optimisation of both bone and non-bone tissue decellularisation processes and in conjunction with sensing technologies, could accelerate further research in developing a commercially viable system to manufacture commercial decellularised tissue products.