STEM CELL RIP-OFF

Vladimir Bryntsalov, a Moscow pharmaceutical tycoon, decided last year on the advice of a friend to seek a treatment for the gray hair and wrinkles that come with being 58 years old. He had a potent mixture of human embryonic stem cells injected under his skin. It is a radical procedure with unpredictable results under any circumstances, let alone in a Moscow beauty salon. A few weeks later, Bryntsalov was as gray, wrinkled and tired as ever--and sported several pea-size tumors on his face. He began to doubt that the salon was legitimate. "They didn't have a laboratory, nothing," he says. "Who knows where [the stem cells] came from?"

Welcome to the frontiers of stem-cell therapy. Much of the world's collective medical intellect is being trained on these little cells, which appear in their purest, most powerful form in the first few days of a developing embryo. They have the unique power to turn into any type of cell found in the human body. Because they're so controversial, proponents have taken to hyping their promise as a medical treatment. The message that seems to have gotten through to people like Vladimir Bryntsalov is this: stem cells are the key to curing incurable human ailments. And if stem cells might fix spinal-cord injuries and Parkinson's, think what they'll do for baldness!

Stem cells, of course, are a long way from curing anything--treatments are at present largely theoretical. But that hasn't stopped about 50 beauty salons and medical clinics in Moscow from using stem cells in a variety of cosmetic treatments and other remedies, often under the guise of medical research. They operate unregulated by the government and often without adequate medical supervision. Many of them don't even take medical histories from patients, much less follow up on possible complications. By some accounts, those complications can be severe: tumors, depressed immune systems and blood infections. And the treatments have virtually no scientific or medical merit. In the worst case, stem-cell injections "have clear potential to grow into a malignant tumor," says Dr. Timothy Hardingham of the Centre for Tissue Engineering in Manchester, England. At best, the Russian doctors' practices are "close to witchcraft."

The clinics claim to be able to cure wrinkles, hair loss, dry skin and some dental problems by injecting what are claimed to be cultures of stem cells, taken from human embryos, under the skin. Some clinics cultivate patients' own adult stem cells--typically found in bone marrow or fat, they are much more limited in their ability to morph into other types of cells--and then inject them intravenously. A 50-year-old American woman suffering from anxiety and sleeplessness traveled to Moscow last month to Stem Cell Higher Technologies Inc. for her second $15,000 treatment in two years. It's a big expense on her $65,000-a-year salary, but "within two months of the first treatment I could finally rest normally," she says. "I could finally concentrate again at work."

Are the benefits worth the risks? In the absence of scientific studies there's no way of knowing. The American patient could be experiencing a miracle cure or a placebo effect. The risks could be significant. Aside from the possibility of infection, nobody really knows what stem cells do when placed among the tissues of the human body. No clinical trials have been done on stem cells as a treatment for wrinkles.

In a sense, Moscow is now running the world's biggest clinical trial of stem-cell therapy for cosmetic purposes. But any result is inherently suspect: in a true clinical trial, doctors would be gathering data according to a well-designed research plan. That's hardly the case in Moscow. Following a 10-minute consultation with a cosmetologist, one beauty salon, located in an apartment building in a Moscow residential neighborhood, is ready to begin an $800 series of three stem-cell injections aimed at wrinkle removal.

It's not clear what's being injected beneath patients' skin. Are they embryonic stem cells harvested from days-old embryos? Such "undifferentiated" cells would be the most promising candidates for repairing organs, from alcohol-addled livers to wrinkled skin, but they are also the least predictable and potentially most dangerous. "If we introduce undifferentiated cells into the body of a person with low immunity, then there's a high risk of cancer," says Gennady Sukhikh, a stem-cell scientist from the Russian Academy of Sciences.

Some clinics advertise human-embryonic stem cells, but in fact take them from pig embryos. The Kosmeton clinic, which rents space in a tony Moscow neighborhood from a medical facility with ties to the Kremlin, openly admits to luring patients with empty promises. "In our advertisements, we say that we have stem cells," says Yelena Chelishcheva, who works at the clinic. Clients actually get an injection of skin cells.

Nobody is saying which, if any, clinics are using the superpotent undifferentiated cells and where they come from. Clinics that use older cells buy them from the Medicine and Biotechnology Co. in Yekaterinburg, the only firm licensed to produce and sell the cells for medical purposes. Business is booming. The firm has offices in 30 cities and plans to open its own treatment clinics. The salons pay about $50 for a 10-milliliter dose of stem cells, enough for a single treatment that typically costs patients more than $150.

None of these beauty salons operates legally, according to Andrei Yuriev, an official with the Federal Inspection Service for Health and Social Development. "But, for now, we're not going after the offenders," he says. The service has 131 inspectors to oversee the entire country. Cracking down on beauty salons, he says, is the job of the country's notoriously corrupt police.

Meanwhile, the number of clinics in Moscow is mushrooming. Bryntsalov, even after three months of painstaking removal of his facial tumors, is now getting injections of adult stem cells taken from his bone marrow. (He's switched clinics, however.) By his own account, he's spent "hundreds of thousands of dollars" on the treatment and signed up his daughter and two sisters. "My gray hair is growing darker. I'm losing wrinkles," he raves. "And I feel like I did when I was 20." The clinic, the Institute of Biological Medicine, is licensed as a medical-research facility and has a waiting list that stretches until March. The chief physician, Dr. Yury Bloshansky, insists he's operating within the law. Other clinic owners are lobbying health officials for licenses to perform adult-stem-cell treatments.

Ironically, serious science may yet benefit from the Russian free-for-all. Dr. Andrei Bryukhovetsky, a scientist at Moscow's Cancer Institute, is using the adult stem cells of spinal-injury victims to repair vertebrae. "This is the one area where we are ahead of the Americans," says Bryukhovetsky, "and it's only because our laws allow us to use stem cells, both embryonic and adult." Bryukhovetsky also has a front-row seat when stem-cell treatments go wrong. A 23-year-old woman, who had paid $10,000 for a series of stem-cell injections for a concussion, went to Bryukhovetsky complaining of severe headaches and a breakdown in her immune system. The risks are obvious to him, if not to all.

STEM CELL RIP-OFF | News