Isolagen, an anti-wrinkle treatment which involves injecting patients with collagen-producing skin cells, was taken off the market in
the United States four years ago after the Food and Drug Administration (FDA), which regulates medical treatments, said that there was no clinical evidence yet that it was safe.
However, Isolagen became available In Britain in November last year and a few hundred people have had the £2,500 procedure, despite warnings from health watchdogs and cosmetic surgeons.
Simon Williams, a spokesman for the Patients' Association, said:
The treatment involves removing collagen-producing cells from behind a patient's ear, culturing them in a laboratory, and
re-injecting them into the face.
"People buying this procedure are putting themselves at an unknown risk. None of us wants to stop innovative work, but I certainly would not advise any friend or relative of mine to spend £2,500 on a procedure that has insufficient research backing."
In theory, after several months the cultured cells begin naturally smoothing out wrinkles by producing collagen, which is nowadays widely injected into people's faces or lips to create a "plumping" effect. The technology behind Isolagen was discovered by accident in the mid-Nineties by William Boss, an American plastic surgeon. The treatment, which is marketed by Isolagen Inc, involves removing collagen-producing cells from behind a patient's ear, culturing them in a laboratory, and re-injecting them into the face.
It may take up to three years at least before the Isolagen treatment could have completed clinical trials, had its findings reviewed by the FDA, and reached the stage of asking the FDA for biological device approval.
In Britain, the treatment is not covered by existing regulatory bodies and so it is offered at about 60 private treatment centres.
Mr Sexauer, the vice-president of Isolagen Europe, claimed that Isolagen had been approved by health regulators in Britain. The Department of Health said that it had simply told the makers that Isolagen did not fall within the scope of the Medicines and Healthcare Products Regulatory Agency, the body which has succeeded the Medicines Control and Medical Devices agencies.
Among the experts urging caution is Dr Nicholas Lowe, a clinical professor of dermatology at the UCLA School of Medicine, Los Angeles. "I, like the FDA, felt there should have been considerably more controlled research conducted on this," he said. "Sadly, with many of these treatments there is inadequate research conducted before they are released in Europe. The British are basically guinea pigs.
On the other hand...
it is reported that Lucinda Ellery, 49, a hair salon owner from Richmond, south-west London, is thought to have been the first woman in Britain to have had the treatment and that she says to be delighted with the results:
"I started to notice the changes within a couple of weeks, and since then instead of depleting after a few weeks it has just got better and better,"said Ms Ellery, a veteran of cosmetic surgery who has tried most of the other treatments on the market.
"It is the best thing I have ever had done, and the most successful. I feel psychologically and emotionally more relaxed about this, as they are re-injecting my own cells rather than some chemical. People say I look younger than I have done in 10 years!"