3D bioprinting technologies hold huge potential to transform patient care and treatment, delivering the next generation of personalised medicine. But current legislative boundaries are poorly defined, and the pathways to approval are unclear, creating unnecessary delays and costs in getting these new technologies to patients. Here, Dr Marco Domingos from the Bioprinting Technology Platform argues that a better legislative framework needs to be rapidly implemented if the NHS wishes to remain at the forefront of patient care.

• Bioprinting and biomaterials have the potential to improve treatments and prognosis for conditions such as osteoarthritis (OA), among others.
• The current regulatory landscape does not support the scale-up of this new technology as it falls across multiple regulatory boundaries.
• There are currently no standardised production methods or quality certifications to ensure efficacy and safety.
• New medical technologies should be supported by legislation and funded by both the public and private sectors to ensure equitable access.

Printing a repair

Osteoarthritis (OA) is a condition where the cartilage between bones, most commonly the knees and hips, is worn away, causing the joint to become painful and swollen. Nearly nine million people in the UK are affected by the condition and it can severely impact upon their quality of life.

Mild cases of osteoarthritis may be managed with exercise plans and painkillers. However, for many people, the condition is long-term and gets worse over time, with progressive loss of cartilage and bone, leading to a joint replacement.

While many joint replacements do improve a patient’s prognosis, they often do not restore full mobility to the joint, and large and invasive procedures carry substantial risk, especially when carried out on elderly people. As osteoarthritis affects mainly those over 65, consideration should be given to whether invasive surgery is appropriate. Additionally, the new joints are usually made from metal and plastic which can have a negative effect on the surrounding bone, further weakening it to the point where revision surgeries are necessary.

To address this, the Bioprinting Technology Platform in the Henry Royce Institute at The University of Manchester, is looking at ways to improve patient outcomes by 3D printing new cartilage made from the patient’s cells and in combination with advanced biomaterials. This alternative strategy, termed ‘bioprinting’, aims at stimulating the body’s own regenerative capacity to restore rather than repair or replace the damaged tissue. In bioprinting, mammalian cells are encapsulated inside hydrogels – highly hydrated 3D polymer networks – to create a biological ink (“bioink”) which is then shaped into a given structure, such as heart tissue or cartilage, using additive manufacturing principles. Bioprinting can be combined with medical imaging to generate patient-specific implants and return the joint to near full functional mobility with minimal side effects and using less invasive surgical procedures.

The major advantage to using 3D bioprinted tissue is that it’s made from the patient’s own cells, structured to mimic functional organisation of the native tissue, which reduces the risk of rejection and speeds up recovery time.

The printers are jammed

One of the largest problems facing this new technology are the regulations governing the pipeline from lab to application. It is unclear which regulatory framework should be followed – current frameworks for cell therapy and medical devices, while relevant, are not entirely appropriate.

Compounding this problem is the lack of standardisation in producing and certifying bioprinted products. For example, one lab could follow a certain method for making cartilage which differs from another lab’s method – but both say they produce cartilage. They could also verify their own materials, leaving the materials open to variation in their quality, safety, and effectiveness.

As with any cell technology, attention needs to be paid to the security and ethics of using something as personal as people’s cells. Storing and using cells, especially if they are being genetically modified, unfortunately creates a risk of misuse. To ensure patient safety and security, there must be checks in place that guarantee cells are only used for their intended therapeutic application and that full patient consent is obtained prior to any cells being taken.

The UK Biobank, which stores genetic and health information from 500,000 participants, could serve as a starting model for how to govern access to patients’ cells – though it is likely an added layer of protection will be needed to ensure these cells are used appropriately.

In terms of cell sources, using specific cells, such as heart or muscle cells, limits their use to only that part of the body, whereas stem cells can grow into any cell in the body. Researchers are looking at induced pluripotent stem cells (iPSCs) as an attractive solution. iPSCs are cells taken from adult patients and reprogrammed (‘induced’) to a stem cell state where they can then become any type of cell in the body (‘pluripotent’). These cells also allow for continuous replication without differentiation (self-renewal) and would create the best bioinks.

Finally, as with all new medicines and treatments, there is the issue of cost. New cell therapies are expensive, and this can preclude fair access, especially if the technology is bought and patent-protected by international medical companies. To prevent this, regulators must be ready to step in and require these new technologies to be made accessible at a fair price, while investment should come from both public and private sectors so the pipeline to application is de-risked.

With these things in mind, policymakers – particularly those at the Department for Science, Innovation and Technology; the Department for Health and Social Care; and the Office for Life Sciences – should:

• Establish a working group of researchers, clinicians, industry professionals, and policymakers to assess the current landscape for biomedical materials, and introduce regulations that support their scale-up from lab to clinical application.
• Create robust production methodologies and characterisation standards to ensure biomaterials meet the necessary criteria to be safely used in medical applications. This could either be a UK-set standard or developed in conjunction with other countries.
  • A UK Centre of Excellence in Regulatory Science and Innovation (CERSI) could play a role in centralising and coordinating knowledge and efforts around regulation of bioprinting.
• Ensure the ethical framework and digital security for cell therapies is bolstered to safeguard patient information.

Life sciences are a core pillar of the UK’s overall science and technology strategy, reflected in funding announcements in 2023. However, the sector is struggling with complex, overlapping layers of regulation that stifle innovation – something recognised by the life sciences pro-innovation regulation of technologies review.

The UK has the expertise, facilities, and people to take a global lead in emerging areas, including bioprinting. Enabling this requires policymakers and regulators to create a nurturing environment to research, test, and bring these new technologies to market in a safe and timely manner.