Legislation gives backbone to human tissue engineering

The European Commission is proposing to harmonise legislation governing the sophisticated manufacturing processes involved in human tissue engineering.

The first products being developed in this growing field include artificial skin, cartilage and bone. The EC said that the novel technology required to make these products promised to change medical practice ‘profoundly’ by regenerating diseased tissues and organs instead of just repairing them. However, in a policy paper on the subject, the Commission said progress was being hindered by the differing regulations throughout the 15 EU member countries.

In the pipeline are products to treat cardiovascular disease (technology to make tissue-engineered heart valves, vessel grafts and heart muscle tissue), neurodegenerative diseases such as Alzheimer’s and Parkinson’s, and damaged nerve fibres and spinal cord injury. The goal is to be able to construct in vitro organs including the bladder, kidney, heart, liver and pancreas.

One of the leaders in this field is the Tissue Engineering Group at Nottingham University, which is involved in, among other things, synthesising novel biodegradable and biomimetic materials to generate scaffolds that support cell and tissue growth.

Professor Kevin Shakesheff, head of the group, said that the UK had a thriving tissue engineering community and was starting to see commercial spin-out firms. ‘We can’t plan for the future unless we know what regulatory hurdles we’re going to face so this is a very good step,’ he said.

He said a lot of useful tissue engineering technologies were being developed that would enter the market a lot more quickly with a harmonised EU regulatory system. ‘It may not be a whole organ, but a material, such as a stem cell, that helps the body repair itself. Those therapies are coming along quickly so we need the regulatory framework in place as soon as possible.’ This field of medicine could grow to compete with the pharmaceutical industry, he said.