StemCell Therapy

The phrase stem-cell tourism often conjures images of back-alley clinics in distant lands, destinations such as Mexico and China, to which, increasingly, desperate patients are travelling to undergo risky and unproven treatments.

But according to new research, another country is being overlooked in the debate over stem-cell tourism: the United States.

In a study published Thursday by the journal Cell Stem Cell, researchers analyzed the Internet to find that there are 351 businesses in the United States, collectively operating at least 570 stem-cell clinics.

The clinics advertise treatments that involve injecting primitive, undeveloped cells into patients bodies. They also claim to treat a laundry list of problems, from autism and Alzheimers disease to sexual dysfunction, even though clinical trials have not proven that stem-cell treatments are safe or effective for any of these.

But, if the size of the marketplace is any indication, American stem-cell clinics are doing booming business, even attracting patients from Canada, and charging thousands or tens of thousands for their services.

Experts agree that the science is at a tipping point, but it moves slowly and stem-cell therapies arent ready yet for prime time, according to Timothy Caulfield, a University of Alberta professor and Canada research chair in health policy and law.

Caulfield warns that the list of diseases with proven stem-cell treatments is still incredibly short.

Regulators in Canada and the U.S. have, for the most part, approved things such as skin grafts or bone marrow transplants for blood cancers such as leukemia.

These clinics are really leveraging the excitement around the field, Caulfield said. People think there are all these efficacious stem-cell therapies that are available now, and thats really not the case.

In the study, researchers found that stem cell clinics in the U.S. are clustering in certain cities, such as Beverly Hills and New York, and states such as California and Florida

Most advertise autologous stem cells, cells mined from the patients body, typically fat tissue. An estimated one in five clinics claim to use stem cells sourced from amniotic material, placental tissue or umbilical cords. And at least two clinics advertised using bovine amniotic cells.

But because these clinics are not regulated, patients have no way of knowing what they are being injected with, said study co-author Leigh Turner, a bioethicist with the University of Minnesota.

Maybe patients are paying $15,000 for whats effectively a blood transfusion.

He noted that many businesses also advertise the same stem-cell procedure for treating a wide range of highly complex disorders, something that should serve as a warning sign.

Turner believes his study highlights an urgent need for federal regulators to crack down on stem-cell clinics, closing regulatory loopholes that have allowed them to thrive.

Its difficult to see how these could possibly be compliant with federal regulations, Turner said. What we have is rampant marketing of unproven, unapproved stem-cell interventions, all of it happening in the U.S., all of it happening beneath the nose of the FDA.

A main concern, of course, is that these treatments come with unknown risks.

Study co-author Paul Knoepfler points out scientists still dont understand the harms that could arise from stem-cell injections, both short and long term.

Maybe theres a moderate risk, but it doesnt manifest until 10 to 20 years later, he said.

Some of these risks, such as blood clots, have been documented by the scientific literature.

There have been high profile disasters: patients in Florida and Europe who have died after stem-cell treatments, or a California woman who developed bone fragments in her eyelids after undergoing a stem-cell facelift.

One woman who participated in a clinical trial in Portugal developed a growth in her spine, a growth that had nasal tissue and bits of bone in it.

The New York Times recently reported the horrifying story of a stroke victim who spent $300,000 on stem-cell injections, only to develop a huge mass in his spinal column, which has left him paralyzed from the neck down.

His doctors have no idea how to stop the mass from growing.

You can get the wrong type of tissue growing in the wrong place, said Knoepfler, a professor with the University of California, Davis.

And, if a stem-cell transplant goes wrong, thats a living thing, you know?

There might not be a way to undo that.

Stem-cell tourism is largely driven by patients who describe seemingly miraculous cures. These people can be celebrities such as Gordie Howe, who lend their star power to the stem-cell industry, or ordinary patients such as Tina Kapel, a 49-year-old woman from Stouffville, Ont., who has Parkinsons disease.

Kapel said she has refused the drugs recommended by doctors because she distrusts pharmaceutical companies and doesnt like the side effects. Instead, she has turned to a Paleo diet, acupuncture and naturopathy.

Last year, she stumbled on stem-cell treatments after Googling terms such as reversing Parkinsons and natural cures. At the urging of her naturopath, she flew to California for a stem-cell procedure.

The procedure cost $14,995 U.S., which she paid using lines of credit and loans from friends and family. She is unable to work because of her Parkinsons and finds herself in a horrible position financially, but says she would do it all over again.

Im better than I was before the transplant, she says, adding she hopes to get another treatment, and is now trying to raise money online for more injections. When you live in a Parkinsons body, the reality is Im willing to take the chance.

Knoepfler and Turner hear from patients all the time. But they said that, without good clinical trials for treatments, its impossible to know whats really going on with them. Is there something else the patient is doing that might account for the improvements? Could they be experiencing a placebo effect, an undeniably powerful force, especially when patients are desperate and have invested tens of thousands of dollars?

Or perhaps the treatments do work. The only way to know for certain is through research, not relying on anecdotes, Caulfield said.

For now, stem-cell clinics and their claims should be treated with extreme caution, he said.

If it was that easy to translate this stuff into treatments, that would be happening; the best scientists in the world are working on it, Caulfield said.

We all want it to work . . . if only it was that easy.

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U.S. overlooked in debate over stem-cell tourism ...

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