The development and implementation of a six-axis bioreactor for regenerative therapies of the intervertebral disc

Back and neck pain are extremely common conditions globally, and the degeneration of the intervertebral disc is commonly associated with this pain, or is a contributor to the degenerative cascade leading to pain in other structures of the spine. The intervertebral disc is a complex structure, and both the mechanical and biological environment play an important role in the health and maintenance of the disc. However, the effect of complex physiological loading on the cellular behaviour in the disc is unknown, and this limits our understanding of disc degeneration, and our ability to adequately develop and evaluate regenerative treatments for disc degeneration.

This project will develop and implement the first six-axis bioreactor, which will be capable of applying complex physiological loads to whole intervertebral disc cultures. This will provide unique opportunities to investigate the coupling of mechanical and biological environments relating to disc degeneration, and in the development, optimisation, and evaluation of regenerative treatments for the intervertebral disc.

The project will benefit from the support of a Visiting Academic (Professor Justin Cooper-White) who has developed novel, injectable, hydrogel-based regenerative therapy for the intervertebral disc, and the final part of this project will be to evaluate the effectiveness of this therapy.

The medical technology market value is currently estimated to be over $400 billion. This market has shown consistent growth over the past decade, and is predicted to have a value of over $500 billion by 2022. A key sub-sector of this market is regenerative medicine, which had a global value of over US$17 billion in 2016, and is predicted to grow to over US$50 billion by 2025. The UK has substantial expertise with which to gain a significant share of this market. The development of clinically viable regenerative therapies for degenerative disc disease will drive further UK investment, and this project will deliver novel capabilities to achieve that goal.

The pathways to improved medical device design and innovation that this project will provide not only has the potential to lead to UK growth in the medical technology and regenerative medicine markets, but will also contribute to reducing back pain, which is the leading global cause of years lived with disability, and reduce the economic burden of back pain, which costs the UK over £10 billion per year through both direct treatment costs, and indirect costs due to work absence and losses in productivity.

A key aspect to developing regenerative therapies is the ability to simulate the in-vivo environment during the device development. This is particularly challenging in the intervertebral disc, which has a complex microstructure, six degrees of freedom, a low cell density, and is avascular. This makes the mechanical properties of treatments critical in restoring joint function, and the provision of appropriate disc nutrition key in ensuring cell viability for the regeneration and long-term maintenance of the disc structure. The proposed project will directly address these needs, through the development of a system with the capability to simulate complex physiological loading and monitor disc nutrition, combined with the evaluation of cell viability and disc composition. This will lead to a significant step forward in the understanding of spinal loading, and the development and evaluation of new regenerative devices. The project outcomes will provide immediate benefit to the academic community, and will lead to advances that can be adopted by the medical device industry. Through clinical translation, this will ultimately lead to improved patient outcomes, and provide a significant positive impact on society as a whole.