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Turning stem cells into snake oil Add to ...

It was the ZsaZsa Luxe Rejuvenation Crème that tempted me.

I'd been up half the night with a restless toddler, and bags the size of Hungary sagged under my eyes. I wanted to believe ZsaZsa would “restore that youthful 24-kt gold glow,” as it claimed, and “infiltrate deep into your cellular levels like never before and reverse the effects of aging.”

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It was “formulated by Top Scientists in France,” using “only the most exclusive BioMarine Technology, Sea Fennel, Swiss Apple, Grape Stem Cells, the World's Most Exclusive Peptide, Antioxidants, Caviar and Black Pearl … helping kick-start your skin's natural stem cells to halt that aging process!”

A lotion to kick-start my stem cells? A French lotion of caviar, pearls and grape stem cells – would they grow in bunches on my face? I snapped out of it: In a dozen years of reporting on stem-cell research, I'd never heard they could come in a jar.

But the pitch was only one of a growing number I'd seen recently, peddling the power of stem cells to make a younger me.

In science, “stem cell” has been the buzzword of the decade, and with good reason: The body's master cells are a protean dream, immortal chameleons capable of sprouting into the various tissue types that make up a human.

Scientists speak of one day using them to conquer incurable diseases and grow new body parts when old ones wear out.

But researchers still have much to learn. Not least of which is how to keep the cells from growing out of control, into cancerous tumours.

Yet in the direct-to-consumer world of cosmetics and dubious cures, stem cells have already made the leap from lab to market.

From Beijing to Beverly Hills and Manila to Mississauga, private clinics, companies and high-priced spas are pushing stem-cell creams, supplements and procedures for every freckle under the sun.

Claiming to use patients' own stem cells, these purveyors offer stem-cell facelifts as well as stem cells for baldness, eyelash extensions, buttocks augmentations, breast enhancements and penis enlargements (girth, not length).

In a Mississauga clinic, even aging, ailing pets are sold the possibility of youthful pep.

It “has become a global problem,” says Douglas Sipp, who monitors alleged stem-cell treatments at the RIKEN Center for Developmental Biology in Japan. There's no proof the treatments really use stem cells at all, he says, or that doing so would be safe or effective: “To the best of my knowledge none of these has a basis in scientific evidence.”

The established facts about stem cells are amazing enough: They can be grown into a tooth, brain cells, a bladder or heart tissue that beats in a dish. Cells from a single infant foreskin can be grown into a sheet of skin the length of three football fields. Salvaged from the eyes of dead people, stem cells have enabled blind mice to see.

“It's that fantastic, the potential,” says Robert Lanza, chief scientific officer at the Massachusetts-based Advanced Cell Technology, which is about to launch the first human embryonic-stem-cell trial to treat blindness.

The trouble is, he says, “The public can't discern what's real. Not even scientists can discern. So, yes, it's very easy to take advantage of that.”

Stem cells, the Britney Spears of modern biology

This is very awkward for a field that has had an image problem from the get-go. From the moment stem cells were plucked in their most powerful form from an embryo in 1997, scientists have played up their potential while social conservatives denounced them.

The work has become entangled with debates on abortion and cloning and, with Korean researcher Hwang Woo-Suk's indictment in 2006, linked to one of the most high-profile cases of scientific fraud.

So much hype, so much scandal – stem cells have become the Britney Spears of biology.

And the spotlight is bound to intensify. Machines are making their way to the North American market that allow for the fast extraction of adult stem cells from a patient's fat tissue, opening the door for the cells to be added to any product or procedure.

Meanwhile, regulators are still finding their footing in this murky, fast-moving field.

“Some of the legitimate science is going to be under a bar of fake pressure,” says Mick Bhatia, director of stem-cell and cancer research at McMaster University in Hamilton.

“Patients will say, ‘If they can grow stem cells this quickly to fix my dog, if they can be bottled in a cream, why can't you use it to fix my heart?’ ”

Science has a long history of being hijacked by hucksters. Bogus genetic tests abound, as do suspect colon cleanses and oils to grow your telomeres. Right back to the days of bloodletting, storefront barbers would slice for a price as a supposed cure for everything from gout to acne.

But stem cells are big business. Treatments can run from a few thousand dollars to more than $40,000, according to Tim Caulfield, a lawyer and bioethicist at the University of Edmonton who has written many papers on the subject.

Thousands of people a year – whether desperate patients with chronic diseases or healthy ones in search of a nip or tuck – pay the price.

“The conditions are perfect for quackery,” Prof. Caulfield says. “The phrase ‘stem cells' is synonymous with ‘cutting edge.' From a scientific perspective, it's a very loaded term. And for marketing it's a very exciting term.”

And the market is booming. With the spread of patient activism, the growing mistrust of the medical establishment and the flood of information on the Web, patients can shop the world's clinics not only for faster or cheaper treatments, but for those unproven by mainstream science.

Hair like Superman's, in a single bound

All Terry Lidstone knew about stem cells before he agreed to have his own injected into his head was that they seemed like a powerful, complicated piece of the future. But, as he tells me by phone from his home in St. John's, all he really cared about at the time was his hair.

Mr. Lidstone had loved his hair – thick and blond, “it was beautiful.” Losing it at the age of 35 was the worst thing that ever happened to him.

“I was totally destroyed by it,” says the self-described millionaire, now 52. “My wife will tell you: I would get pissed off every morning. … I stood on my head for years to get the blood going to my scalp.”

Worse, as the prominent owner of a string of Newfoundland gas stations with 90 employees, he was regularly in the public eye. He considered a hair transplant, but had an aversion to hospitals. Only wintering in Florida finally changed his mind.

“Tampa is the capital for cosmetics,” he says. “Sunshine, everyone looking good, in bathing suits all the time. … Florida pushed me over the edge.”

That's when he found John Satino, owner of the Hair and Scalp Laser Clinic in Clearwater, Fla. The online information impressed him, as did meeting Mr. Satino – “he's charismatic.” He also liked the doctored pictures on the clinic wall of a bald Bill Clinton, Elvis Presley and Superman – which “showed you the difference hair makes.”

Mr. Lidstone had signed up for a standard hair transplant when Mr. Satino told him he was also trying something new with stem cells: He could use the ones in Mr. Lidstone's own blood to enhance the transplanted follicles on his crown and to encourage new growth. Mr. Lidstone decided to pay the extra $1,500.

“[Mr. Satino]told me there were no guarantees,” he says. “He told me, ‘You'd be the first Canadian to have it done.’ ”

Who is keeping watch?

Many companies say they can use a patient's own stem cells in the treatments they market. Adult stem cells, however – extracted from blood, fat, bone marrow or other body parts – do not have the same shelf life or versatility as those from an embryo, which can renew infinitely and grow into all of the body's tissue types.

Anti-abortion opponents of embryonic stem-cell research have helped the world's hucksters by spreading misinformation, says Sean Morrison, director of the International Society of Stem Cell Research (ISSCR).

“Both president [George W.]Bush and the Catholic Church have all said, ‘Oh, why use human embryonic stem cells, when there are plenty of stem cells in umbilical cords?' – implying that all stem cells have equal powers to regenerate.”

Mr. Sipp of the RIKEN institute, a member of the ISSCR, adds that clinics often use various agents to manipulate a patient's stem cells to grow into the tissue they want – “and the risk increases that their chromosomes will become unstable.”

Dr. Morrison, who also heads stem-cell research at the University of Michigan, says that even in cosmetics, where plastic surgeons have long transferred fats and tissues from one body site to another, unproven stem-cell procedures pose a potential danger.

In December, reports surfaced that two patients had died after receiving "anti-aging" stem-cell infusions through a South Korean biopharmaceutical company.

This week, prosecutors said they are investigating the Seoul-based RNL Bio, which has treated an estimated 8,000 patients, for selling unapproved stem-cell therapies, some of which are alleged to be prepackaged products patients had injected by other out-of-country doctors.

In a bid to protect patients and the legitimacy of their own work, scientists have taken the unusual step of trying to police suspect claims themselves. The ISSCR has launched a website where the public can glean facts about stem cells and report companies selling unproven treatments.

And this fall, the American Association for Aesthetic Plastic Surgery created a task force to investigate untested stem-cell therapies in the U.S.

Association president Felmont Eaves of North Carolina says stem-cell use in cosmetic procedures is an exciting, promising area of research, but to offer treatments now is “emotionally … [and]psychologically manipulative.”

Dr. Eaves says, “At this point, there is absolutely no clinical evidence that they're activating or even processing stem cells.” Some clinics claim to add them to transplanted fat tissue, he adds, “but fat grafts work pretty well on their own.”

To harvest stem cells and confirm their presence takes time, adds McMaster's Dr. Bhatia. Many clinics suggest that they can grow them in a few hours, yet he says it takes at least eight hours for any mammalian cell to grow.

If they really are using stem cells, it may be even worse: “Once you take a cell out of its normal environment and grow it in a dish, the ones that grow well do so because they have mutations that you call cancer – and then you are going to put these high growers back in another site of the body?”

He adds, “You hope the work is going to help someone legitimately, but I worry the claims compromise the whole legitimacy of the field. … And there is a frustration to all the testimonials these companies offer: If it is true, why isn't it published? Why isn't it out there?”

‘Turbo-charging the hair follicle'

John Satino says he has always intended to publish. He says he has long been involved in new technologies to treat hair loss, having run tests on Rogaine in 1985, on Propecia in 1989 and on the HairMax Laser Comb in 2003 – “every FDA-approved modality for hair loss.”

So in 2008, when a masseuse on his staff told him that Arabian racehorses in Sarasota, Fla., received stem-cell injections that healed their joints and regrew hair, he decided to give it a try.

Mr. Satino opted to do it with platelet rich plasma (PRP), essentially a substance that requires a patient's blood sample to be processed in a machine that separates and concentrates its platelets. The platelets, which hold a number of growth factors, are then injected back into the patient, often to heal sports injuries.

He says the U.S. Food and Drug Administration has approved PRP injections into soft tissue, but not specifically for hair loss nor as a source of stem cells.

He treated the first patients free, Mr. Satino says, thinking, “ ‘Let's just inject something and see what happens.’ … And it looked good,” he says. “And it wasn't going to hurt anyone.

He estimates that he has done 500 patients – men and women – and that 80 per cent of clients do respond. It works best for young men with thinning hair, he says: “I think stem cells are turbo-charging the hair follicle.”

Still, Mr. Satino admits that he does not know if he is actually injecting any stem cells into customers' heads. He does not extract, purify or count them, and does not track their presence after an implant. “We haven't really gone there,” he says. He would if they were conducting a formal study. “I cannot say for sure that it is stem cells.”

He agrees that it may be a placebo effect, the plasma or the injections themselves stimulating growth. Still, his clinic website features the procedure as a stem-cell treatment under the heading, “Breakthrough Technology.” Patients – charged $1,200 (U.S.) for one set of injections – have come from as far away as Scotland.

Mr. Satino says he thinks that it's a good idea to crack down on unproven stem-cell therapies in the cosmetics field, describing outlandish claims he has seen online. “If you're going to market a snake oil, call it a stem cell – that's the way to do it.

“Hopefully, we're not falling into that category,” he adds. “We're not promising anyone anything. … Really, we turn away as many people as we accept.”

He plans to publish his work next year in the Hair Transplant Forum. But it will not be peer-reviewed results of a rigorous clinical trial. For that, he says, you need funding – trials are expensive to run.

“The problem is that no [drug company]wants to fund it, because no one has the rights to it: It's the patient's own cells.”

Globetrotting cure shopping

The grey market in stem cells appears to be one of the first to thrive in what Jonathan Kimmelman describes as the post-global medical economy.

Dr. Kimmelman, a biomolecular researcher and ethicist at McGill University in Montreal, says the 1990s was the “pre-global era” of medicine. Despite the excitement around potential DNA-based treatments at the time, gene-therapy clinics did not spring up in far-flung locales the way stem-cell centres are now, says the former chair of the American Society of Gene and Cell Therapy.

“But it's a very different era now. Brazil, India, China are not inconsequential players in the medical economy,” he says. “There is more transit of expertise – people trained in North America who returned to their home countries, and run trials or do research in their less-regulated, lower-income settings that they could do not here.”

Within the past decade, medical tourism has ballooned into a multibillion-dollar international industry. Increasingly, patients are chasing high-priced treatments unapproved in their own countries. Most recently, for example, hundreds of Canadians with multiple sclerosis have sought out the controversial Liberation treatment in clinics around the world.

Meanwhile, the wide availability of unproven stem-cell treatments is so well established that an international network of brokers, clinic branches and fundraising efforts has sprung up to recruit and counsel potential patients.

Clinics market their treatments as forbidden fruit, Prof. Caulfield says, “with claims that they can sell these things that are severely restricted wherever you are: ‘But we can get you tomorrow's treatments today.’ ”

On the other hand, doctors and researchers offering stem-cell treatments, along with certain patient groups, allege that because big pharmaceutical companies are unlikely to profit from therapies involving a patient's own stem cells, industry-funded scientists and groups are trying to halt their spread.

“There is a kind of skepticism, a level of distrust that patients feel about the relationship between medicine and commerce,” Dr. Kimmelman says, describing a generation of savvier patients who know of the ties between drug companies, doctors and researchers. “Yet they see pharma is not jumping all over stem cells.”

Between the cracks

Both Health Canada and the FDA consider stem cells to be drugs under federal legislation, and as such, subject to the same regulations. But that's less clear when it comes to a patient's own stem cells being moved from the fat of, say, love handles to breasts, or blood to balding head.

The RIKEN Center's Mr. Sipp feels that “a fine balance” has to be struck between allowing patients the freedom to choose treatments for themselves and protecting them from harm.

If a clinic offers an experimental stem-cell treatment, a patient should not be charged for it, he says – “and money is a big problem here.”

He doesn't buy the argument that trials aren't possible, or that using a patient's own stem cells is necessarily safe. Doctors used patient stem cells for costly bone-marrow transplants in women with breast cancer for years, he says, until trials showed they could be more dangerous than the disease.

“With cosmetic procedures,” he adds, “patients are healthy. It's not the same as someone with a serious disease. For them, the benefits may not be as great as the risks.”

One satisfied customer

One day in May, 2009, as Mr. Lidstone ate sandwiches and watched Die Hard Again on the clinic TV, Mr. Satino's staff transplanted his hair follicles from one side of his head to another and injected his own, treated blood into the back of his numbed scalp.

“He had a $50,000 machine right there” to process the blood, Mr. Lidstone says. “So right there, on the spot, every follicle was soaked in my own stem cells. That was pretty neat.”

Today, he's thrilled with the transplant results. The follicles took like weeds, he says: “After 21/2 months, they were an inch long. … Not one of them has died.”

It may be that the stem cells helped their survival, he says. But the area that received only the plasma injections “isn’t doing very well ... about 17 new hairs” by the clinic's last count.

I ask Mr. Lidstone if he has had any safety concerns at all. “I'm shocked I didn't think more about it,” he says. “We knew it was very powerful stuff, but they were getting it from my own blood – I just thought of it as good fertilizer.

“When it came to my hair, I wanted to take a chance,” he adds. “I got all caught up in it, I guess.”

Some mornings, I know the feeling.

Carolyn Abraham is the medical reporter for The Globe and Mail.

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