Yet while regulators in the US are demanding trial results before approving the procedure, in Britain and other countries the treatment is already available. So are regulatory agencies in these countries looking closely enough into cellular therapies like this to guarantee patients' safety?
In the treatment, developed by Isolagen of Houston, Texas, skin cells from the back of the ear are grown in the lab for about 8 weeks, and then injected beneath frown lines and scars by a plastic surgeon. Isolagen claims that the implanted cells grow in the same way as ordinary skin cells and that, unlike collagen fillers or the nerve-paralysing toxin Botox, the effect does not wear off. In fact, it claims, the effects get better over time. If so, it may be the closest anyone has come to achieving true skin regeneration.
"I'm very excited about it. I see the results with my own eyes," says Peter Ashby, a London plastic surgeon, who adds that he has no financial ties to the company. If the success of Botox is anything to go by, Isolagen has a hit on its hands. Botox sales totalled $440 million last year.
But the longer cells are grown outside the body and the more they are manipulated, the greater the potential for unexpected changes. There are already several methods for growing skin cells taken from people with severe burns, to generate enough new skin to treat their wounds, but only a few hundred patients a year get treated. If Isolagen's therapy catches on, tens of thousands of people could soon be treated this way each year- and for purely cosmetic reasons.
Will this reveal side effects not seen so far? "It has crossed my mind," says Ashby, though he still believes the procedure is safe.
"In the end, you have to look at risk and benefit," says Duke Collier, president of Genzyme Biosurgery of Cambridge, Massachusetts. Epicel, Genzyme's method of growing skin for treating burns, has been used since 1987 without problems. Years of research suggest that skin cells grown outside the body "want to do the right thing" when grafted back. There are no reports of them becoming cancerous - the most worrying scenario.
For a cosmetic application, Collier says, the risk must be low, and he believes this to be the case with therapies like Isolagen's. But the truth is that most regulatory agencies are not looking very hard. Britain and Australia place Isolagen in the same category as tissue banks. This means that while the company's labs have to comply with certain standards, it did not have to submit safety and efficacy data before marketing its treatment, says Vaughan Clift, its vice-president of operations. Isolagen is also opening facilities in New Zealand, South Korea and Hong Kong.
The Isolagen treatment was briefly available in the US in the mid-1990s, but the Food and Drug Administration asked the company to withdraw it voluntarily while it decided how to regulate therapies of this kind. It later asked Isolagen to perform clinical trials, though with fewer patients than in most phase II and III trials. The company hopes the treatment will be approved in the US by 2004.
"Outside the US, they are where the FDA was 15 years ago," says Collier. "There is no regulatory framework, no requirement for studies." Yet with all the excitement about stem cells, the number of medical and cosmetic treatments that involve taking a person's cells, manipulating them in the lab and reimplanting them is likely to grow. As long as the FDA demands conventional trials while regulatory agencies elsewhere do not, patients in those countries will be the first to discover if there are any adverse effects.
Author: Sylvia Pagan Westphal, Boston
New Scientist issue: 24 MAY 2003
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