A new medical technique based on stem-cell and human–tissue research could spread viruses and cancers, scientists have warned.
Supporters argue that tissue engineering could heal heart defects, treat deadly diseases and mend broken bones.
But medical experts in Britain and on the continent have separately warned the UK Government and the European Commission that it poses dangers to patients
Tissue engineering uses human cells – rather than machines or complete human or animal organs – to tackle illnesses ranging from heart disease to cystic fibrosis.
Taken from human stem cells or normal tissue, the cells would be cultivated in the laboratory and then implanted in the diseased area of the patient, stimulating the body to grow its own healthy tissue or bone. It could also be used for cosmetic surgery, such as allowing women to grow larger breasts.
But researchers pioneering the technique will face strict safety controls after leading medical scientists expressed mounting concerns that the technique poses "significant risks" to patients.
The Department of Health and the Medical Devices Agency are to issue new draft guidelines before Christmas, which will focus on strict quality assurance rules, safety controls and technical procedures for the industry.
The code of practice, agreed with the Association of British Health Care Industries, is intended as a short-term measure before the European Commission introduces EU-wide controls, which are likely to be supported by ministers.
The commission has been urged by its own expert panel of advisers, the scientific committee on medicinal products and medical devices, to set up a powerful EU regulatory agency on tissue engineering because of the health risks the technique could pose.
Tissue engineering could result in latent viruses, cancers, and other microbiological problems being passed to patients, the committee says in a report to David Byrne, the EU health commissioner.
Unwanted cells could be transferred and others could be modified or "amplified," the report warns. The technique could also be less reliable than some existing medical devices, such as mechanical hearts.
Although this science could lead to "marked improvements" in health care, some of the risks have "hitherto not been seen" which could have "serious consequences," the committee says.
An EU regulatory agency should police the testing and licensing of all tissue engineering in member states, it says. All techniques should be assessed and graded for their risk to patients, and safety and quality-assurance standards should be introduced.Reuse content