Monday, October 17, 2005

Stem cell quackery

I've asked myself before why I still bother to read the Huffington Post from time to time. Even more strange is my propensity to check out even odder things, like the New York Times Style Magazine, while reading the Sunday New York Times. Perhaps it's a morbid sense of amusement at the waifish, suitably runway-weary appearing, Photoshopped models in bizarre outfits in even more bizarre settings, the articles dedicated to conspicuous consumption of clothing and jewelry that I cannot afford, even though I make quite a healthy salary. Or maybe it's the oh-so-trendy tone of many of the articles. Who knows?

Occasionally, though, in all the fluffery, I find an article that actually interests me for reasons other than the bemusement it causes me that so many people could be so concerned with such silly-looking clothing. So it was this Sunday, when I came across an article entitled The Stem Cell:
Although she is just 32, with skin like eggshell and a waterfall of ice-blond hair, Antonina Babosiuk recently found herself noticing certain changes: a roughening of the skin on her face, for instance, and a waning of her ability to shake off jet lag. As vice president of an international jewelry company, Babosiuk follows a brisk schedule, logging regular flights to Hong Kong to buy pearls and to Kyrgyzstan, where she inspects rings and bracelets produced at the company's 400-person factory. Fearing that the long days were taking their toll on her appearance, Babosiuk secured an appointment at Beauty Plaza, a high-end Moscow spa, where she received an injection of stem cells that had been extracted from her own fat and multiplied in a petri dish. The treatment, which cost her roughly $20,000, has become increasingly popular among wealthy Muscovites as a kind of cure-all - one with a reputation for boosting energy and generally restoring the youthful vibrance lost with age. There have also been scattered reports of remarkable effects, from a superhuman ability to go without sleep to white hair that abruptly returns to its original black.
Well that sent my skeptical antennae twitching right there! Stem cells are not easy to isolate, purify, and expand. To successfully cultivate them requires a great deal of expertise, and these cells are easily contaminated with fibroblasts, immune cells, and other non-stem cells. I know, as I've been looking into cultivating endothelial progenitor cells (a type of vascular stem cell) as part of my research. I'd be very surprised if Babosiuk is in actuality getting her own stem cells. One wonders how Beauty Plaza assures its clients that it is actually doing what it says it is doing. Most likely, it's through a lot of hand-waving and pseudoscientific mumbo-jumbo designed to sound impressive to the lay person. Not surprisingly, gullible rich people fall for the hype, hook, line, and sinker:
Babosiuk experienced nothing so dramatic, but one or two months after her visit to Beauty Plaza, she noticed that her hair was more lustrous and that her skin had become softer. "It looks more fresh," she explains. She was so satisfied that she persuaded her husband, a 42-year-old Russian businessman, to have the injections as well. "Stem cells are like vitamins," Babosiuk says cheerfully. "That's why I come in here. If I don't make something for my health, I will look 40 tomorrow."
Can you say confirmation bias? Sure, I knew you could. And paying $20,000 a pop for these injections is strong motivation to look for any sign that reinforces one's belief that the treatment is working. After all, one wouldn't want to be forced to admit one is paying so much money for a worthless treatment that probably doesn't even contain any actual adult stem cells, would one? (I'm also sure that her "fresher" skin and "more lustrous" hair have nothing whatsoever to do with any of the other beauty treatments she is no doubt getting from the Beauty Plaza.) I tell you, I'm in the wrong business. Why slave away doing actual science when you could make $20,000 a pop injecting something--it's not clear what--into wealthy, vain, aging Muscovites?

It should not be surprising that stem cells would be a hot new area for dubious treatments and even outright quackery, which to me is what the Beauty Plaza seems to be offering. They're in the news. They're controversial. They're a hot area of research, with several states, including California and New Jersey, vying to become national or even world centers for research and South Korea making a name for itself as a stem cell-friendly venue for biotech. In theory at least, stem cells do have great potential to treat a variety of diseases, such as Parkinson's disease, cancer, and a wide variety of degenerative diseases. In the more far-out scenarios, if the totipotential nature of embryonic stem cells can be mastered, they could even be used to generate replacement organs for use in organ failure without the need for transplant and the attendant risk of rejection and need for lifelong immunosuppressive therapy. And, yes, perhaps they may even have utility in letting us indulge our vanity and ward off the effects of aging.

But very little of this potential has been realized yet, and it will take years, perhaps decades, to determine what stem cells can and cannot do. At present, stem cells are only commonly used in bone marrow transplantation to treat hematopoietic malignancies. However, there have been reports of possible utility in spinal cord injury (in mice and a couple of human reports), repairing heart muscle damaged by heart attacks (mice and humans), but wide applicability is a long way off and potential complications are unknown. Not that any such concerns stop Dr. Alexander Teplyashin, the proprietor of the Beauty Plaza:
Cheerful and heavyset, with thinning gray-black hair, soulful eyes and a single deep crease on his forehead, Teplyashin is, by his own account, a serious researcher. "Beauty Plaza is the first private scientific institute in Russia to work with stem cells," he claims with a genteel wave of his cigarette. He points to a certificate of participation from a stem-cell conference in Boston, at which he and collaborators presented research showing that stem cells could be isolated from the epidermis. The clinic, he notes, is even outfitted with machines for separating stem cells from the far more numerous fat cells in which they are embedded, as well as an incubator, for growing the cultures. At Teplyashin's request, an assistant slips a culture dish under a microscope, revealing an image of a dozen long-tailed cells, including some, doubled like butterfly wings and stippled with two black dots, in the process of dividing.

Of course, short of analyzing a syringe, there's no way to know whether Teplyashin is injecting his patients with stem cells. But he maintains that he began using them in 2001 and has been experimenting since 1999, shortly after his father died of a degenerative nervous-system disease.
My guess is that he's probably injecting fibroblasts isolated and cultured from his clients' fat, but who knows? If I were a client, I'd want to see the cell surface antigen profile of the cells, to determine whether they really are stem cells or not. Of course, I wouldn't be a client in the first place because I wouldn't be inclined to try such an unproven (and extremely expensive) "therapy" just to get rid of a few wrinkles. Also, even if what Teplyashin is injecting are indeed real adult stem cells, such treatments are not without potential drawbacks and complications. For one thing, stem cells tend to aggregate around sites of injury, making it impossible (at least now) to control where intravenous injections of such cells end up:
While Babosiuk has been pleased with the effect of the shots, stem-cell researchers in the United States seem dubious. "An intravenous injection of cells - euch," says Evan Snyder, the director of the Stem Cells and Regeneration Program at the Burnham Institute in La Jolla, Calif. One problem, Snyder notes, is that you can't control where cells go once you put them in the bloodstream. Given the propensity of stem cells to aggregate around a site of injury, moreover, there's no reason the injected cells couldn't all end up migrating to a cut on your finger. At $35,000 a shot, that would amount to an extraordinarily expensive Band-Aid.
Worse, these cells could result in tumors:
Among others, Dr. Amit Patel, of the University of Pittsburgh Medical Center, worries about darker possibilities. Because there's no way to control where the stem cells go once they're injected, they may end up causing more problems than they cure. Mice bred to have stomach ulcers, for instance, were shown to have a higher incidence of cancer formation at the site of the sores, because stem cells aggregate at those lesions. Adding more stem cells might increase that risk. Likewise, Patel points out, a patient could have a small, undetected tumor growing in the liver or a lung, in which case the injection of stem cells might actually accelerate the cancer.

"Even when I do direct injections to the heart, the majority of the cells don't stay there," Patel says. "Once the cells are in your bloodstream, who knows where they're going to land."
Indeed, one Russian tycoon, after receiving a fetal stem cell injection, developed pea-sized tumors all over his face and legs.

It may evoke a sense of schadenfreude and amusement to watch hyper-rich marks waste huge sums of money on such nonsense in pursuit of fighting the inevitable ravages of time, but it is not amusing to see desperate people with serious and debilitating diseases like multiple sclerosis to waste their precious money in response to the quacks' hype. For example, Svetlana Galiyeva was also a client of the Beauty Plaza, and she is not wealthy:
When Svetlana Galiyeva found a clinic offering to treat her multiple sclerosis with embryonic stem cells, she grabbed the opportunity. Twenty-thousand dollars later she is still in a wheelchair and desperate. And there is no proof her injections had anything to do with stem cells.
Like other forms of quackery, stem cell quackery does its worst harm offering false hope to patients in the worst straits.

Lest one think this sort of premature selling of "stem cell therapy" outside of clinical trials as a seemingly magic elixir to treat all sort of diseases despite the present lack of scientific evidence for efficacy in humans and lack of hard knowledge about potential complications is limited to beauty spas catering to wealthy Russian oligarchs, I would point out that Switzerland has a biotech company called Advanced Cell Therapeutics, offering umbilical cord stem cell "treatments" in Geneva, Spain, Rotterdam, Amsterdam, Bombay, and (how appropriate) Tijuana, Mexico. Its website quotes Christopher Reeve and lists a bunch of "case reports," which in reality appear to be nothing more than self-reported testimonials and patient-rated levels of "improvement," with little or no reported objective measurements reported. Yet, on such thin gruel, this company sells what it calls with unintentional irony "ethical" umbilical cord stem cell therapy, while presenting these disclaimers on its website: "Cord Blood Stem Cell therapy (CBSCT) is not a US FDA approved procedure and is in no way to be construed or presented as a cure for any condition, degenerative disease or injury" and "Significant Clinical Benefits from CBSCT cannot be guaranteed. Information on this site or in any ACT literature should not be construed to represent a guarantee or claim for a cure or clinical benefit to any disease or injury. CBSCT does not serve as a substitute for a participant’s current medical care and prescribed treatment modalities. Nor is CBSCT intended to serve as a preventive measure, treatment or cure of any condition, degenerative disease or injury."

Does anyone see the disconnect here? How is it "ethical" to sell stem cell therapy to patients with the implicit claim that it can help all sorts of conditions when the company itself seems to be admitting in its disclaimer that its own claims are dubious? And why on earth should anyone pay this company for its product when the company itself admits that it is not "intended to serve as a preventative measure, treatment, or cure of any condition, degenerative disease, or injury"? If its stem cell therapy isn't intended as one of these things, then what good is it, really?

The U.S., of course, hasn't been left out. For example, in California, there is a company called Medra, Inc., run by a Malibu psychiatrist named William C. Rader, M.D., who claims to be able to treat Alzheimer's disease, autism (gee, I wonder if he does chelation, too), cancer, cerebral palsy, and a number of other diseases. For $25,000 (paid in advance), Medra will arrange for treatment at a clinic in the Dominican Republic. Other companies offering "stem cell therapy" are discussed here.

The bottom line is that stem cell research, although potentially holding great promise for many diseases, is nowhere near ready for prime time yet. The data presently available regarding its potential uses and efficacy come primarily from preclinical cell culture and animal studies, with the occasional human case report. Worse, we do not yet know the potential complications of their use, the worst of which may be cancer. Until a lot more research is done, offering "stem cell therapy"--whether it be in the form of embryonic, fetal, or adult stem cells or whether they be injected intravenously or subcutaneously--outside the context of a properly designed, controlled, and supervised clinical trial is incredibly premature at best and quackery at worst.

3 example(s) of insolence returned:

At 10/17/2005 6:51 PM, Anonymous Anonymous said...

Well, at least now, they've come out with a new stem cell research thing where there's less chance of an ethical quandry so they actually might get funding so we can put this debate to rest.


At 10/19/2005 3:45 AM, Anonymous Anonymous said...

It is strange that you use Dr. Patel as a source of authority on the danger of stem cell injections and then go on to state that only a few human trials have taken place.

Dr. Patel has directly injected over 100 patients with autologous stem cells and referred patients for commercial treatment in Thailand. The results of his own clinical trial in South America has been accepted for publication and is forthcoming in 2006.

If you look at all of the people treated with autologous adult stem cells for heart disease world-wide the number is several hundred. None of these have had complications and several heart treatments are already commercially available.

While it is right to be wary of quackery. The idea that stem cell therapies are many years away is absurd if one is speaking of treatment for heart disease.


At 1/16/2006 3:17 AM, Anonymous Anonymous said...

Any comments on Tristem's claim on adult stem cells retrodifferentiation process?

Its therapy is being commercially applied at a hospital in PAKISTAN with payment-in-advance exceeding $20,000.

Seemed to have done human trials on Indian nationals a couple of years ago. Created some controversy. Quacky.


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