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Experts call for better regulation of 'stem cell trips'

6 September 2010
Appeared in BioNews 574

Stem cell treatments offered by private, international clinics need tighter regulation, an expert group of doctors, lawyers and bioethicists have warned. They claim vulnerable patients have spent thousands of pounds on unproven, expensive and risky treatments.

Stem cells can grow into various tissue types and - in the future - could replace cells and organs that have been damaged by disease or injury. So far, stem cell treatments for blood, skin and cornea disorders have been licensed for clinical use. But more than 100 private clinics in several countries offer stem cell treatments for a wide range of conditions, including cerebral palsy, Parkinson's, MS and spinal paralysis.

Through anecdotal evidence, the group called Bionet found that - at these clinics - stem cell treatments were being moved into clinical practice without the required safety analysis. Risks from such untested treatments include infection, immune rejection and even cancer. Only through clinical trials will the effects of these treatments be known, the expert group says.

Professor Nikolas Rose, from the London School of Economics, who led the group, told the BBC: 'The key is informed consent. Doctors should be able to tell the patient about the short-term and long-term prognosis and the things we don't know about the risks'.

Pharmaceutical companies are carrying out most of their clinical trials in China so the expert group talked to European and Chinese experts. China passed new regulations in May which require clinical trials before stem cell treatments are offered to patients.

Professor Qui Renzong, vice-president of the ethics committee at the Chinese Ministry of Health, said: 'In China there are about 150 institutions now providing stem cell therapy for diabetes through to spinal injuries.' He estimates that foreign patients were paying around £15,434 for treatments.

There are similar clinics in Russia, India and the United States. Shaun Griffin, of the Human Tissue Authority, said treatments in the UK are tightly regulated and it is thought no such clinics exist in the UK. New European Union regulations will require treatments to provide evidence of safety and effectiveness within the next two years.

The Bionet group also suggests setting quality standards in clinical practice, honesty about the conditions under which germ cells, embryos or embryonic tissue have been collected, and ensuring that stem cells are imported and used under conditions equivalent to those in the receiving country.

Brian MacNeil, a 39-year old who suffered from hereditary ataxia, a muscle wasting neurodegenerative disease, went to China for treatment. He told the BBC: 'All I can say about the treatment I had with stem cells in China was that I felt a great benefit after the first lot of four injections, with lots of therapy as well, and good benefit from my second visit about one year later. I am now feeling some symptoms come back but cannot afford to go for more stem cells. If I could I would'.

Vicci Chittenden has multiple sclerosis. Four years ago, she travelled to the Netherlands for stem cell treatment. She was examined and treated by a medical practitioner, but experienced no health benefits. She does not believe that the treatment was genuine.

A Department of Health spokesperson said: 'Any new therapy or treatment requires carefully controlled and evaluated clinical research before it can be considered safe and effective. In the UK, there is strict regulation to ensure that vulnerable patients are not exploited or put at risk. When stem cell 'treatments' are based overseas, regulatory insight and jurisdiction is particularly problematic'.

'We take this very seriously and strongly encourage anyone considering participating in overseas stem cell 'research trials' or buying Internet treatments to talk to their doctor and follow health guidelines'.

SOURCES & REFERENCES
Foreign clinics offer false hope to ‘stem-cell tourists’
The Times |  1 September 2010
Safety call over stem cell trips
BBC News |  3 September 2010
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