Stem Cell Treatments: 6 False-Hope Warning Signs

Unproven, Risky Treatments Mislead Patients to Seek Cutting-Edge Therapy

From the WebMD Archives

There's a dark side to stem cells: bogus treatments that prey on patients' hopes when mainstream medicine has little to offer.

Stephen Byer stepped far outside typical medical care when his son, Ben, had ALS. He took Ben to China for stem cell-like treatments, and later helped hundreds of people do the same, believing it would help them.

The unproven procedure could have killed Ben. It didn't -- but it also didn't work. Ben later died of ALS. So did the ALS patients Byer now regrets helping get the treatment.

Why take the chance? For Byer, it started with misleading promises online.

"The Internet, while increasing communication, has spawned a horde of charlatans and creeps," Byer says. "We were suckered into one of the earlier forms of stem cell chicanery."

But not everyone who seeks unapproved stem cell treatments feels ripped off. Even though the stem cell treatments Dawn Gusty got in Tijuana, Mexico, didn't ease her multiple sclerosis, she doesn't look back with regret.

That moment -- when hope surpasses science, and when someone claims to be able to bridge that gap -- may be one of the riskiest for patients to handle. And it's one of the most alarming for stem cell experts.

Hope's Dark Side

"It is a very dangerous situation," says Joshua Hare, MD, director of the Interdisciplinary Stem Cell Institute at the University of Miami.

Make no mistake: Hare is all for scientific stem cell research. His concern, he says, is "hype" that glosses over an inconvenient fact: There are no new approved stem cell therapies.

The danger becomes clear if you Google "stem cell treatment." You'll get search results from clinics in the U.S. and around the world touting stem cell treatments for conditions ranging from baldness to ALS (Lou Gehrig's disease).

People who pursue those treatments "are spending huge sums of money to get therapies that are completely unproven and unlikely to work," Hare says.

Aaron D. Levine, PhD, a Georgia Institute of Technology bioethics professor, agrees. "A lot of companies are claiming they can do things right now the science can't support," Levine says.

But it's happening anyway. Famous athletes and politicians have sought the treatments. So why shouldn't we?


No Results, No Regrets

Twice, Dawn Gusty paid $27,000 for stem cell treatments at a clinic in Tijuana, Mexico. Twice, her care there was completely out of step with accepted medical care for her multiple sclerosis.

Twice, the procedure didn't work. Still, Gusty, of Kingston Springs, Tenn., isn't second-guessing herself. She had gone looking for something better than what her U.S. doctors could offer.

"I was being treated by the book, but I am not a textbook case of MS," Gusty tells WebMD. "It was doing no good."

In Tijuana, Gusty got heavy metal chelation , growth hormone shots, drugs to stimulate the production of blood cells, and chemotherapy . Bone marrow drained from her leg was injected directly into her spine, into her muscle, and infused into her bloodstream.

After her first visit, she felt more energetic, although she was disappointed that her condition didn't improve much. After the second treatment, she says she felt "a slight improvement, and then I settled into the same condition I had been in."

Still, she sees a different kind of value in it. "I learned so much," she says. "It changed my direction and put me on the path I am on now. I am not seeing a traditional neurologist, and not taking standard medicine."

6 Warning Signs

The International Society for Stem Cell Research (ISSCR), a group of established stem cell researchers concerned with the proliferation of unproven treatments, has issued a patient handbook on stem cell therapies.

The ISSCR advises patients to seek only stem cell treatments being tested in clinical trials approved by the FDA (or, if abroad, by a national regulatory agency such as the European Medicines Agency). It also allows for smaller studies approved by an independent Institutional Review Board (IRB) or Ethics Review Board (ERB).

The ISSCR lists these warning signs that a stem cell treatment is not legitimate:

  1. It makes claims based on patient testimonials.
  2. The same stem cells are used to treat multiple diseases.
  3. The source of the stem cells is not clearly documented.
  4. How the treatment will be done is not clearly documented in a "protocol" that serves as the medical practitioner's operating manual for the procedure.
  5. Claims there is no risk. All medical procedures carry some risk.
  6. High cost or hidden costs. Legitimate clinical trials don't charge patients. Some even pay them to participate.


Anyone still considering a therapy after checking all of the above can download the 26-item list of questions the ISSCR recommends asking. Ask a doctor or medical professional to help you understand the answers to these questions about the treatment, scientific evidence behind it, oversight of the clinic and practitioner, safety and emergency plans, patient rights, and costs.

"One of the notorious signs of an unproven therapy is the claim it will treat anything," Levine says. "A lot of people say we have stem cells that will seek out your ailments and cure them, whatever they are, anything from spinal cord injury to autism to heart disease . It is hard to imagine how a single therapy could really be beneficial for all of these things."

Stem Cell Treatments and the FDA

In the U.S., the FDA says "stem cells, like other medical products that are intended to treat, cure, or prevent disease, generally require FDA approval before they can be marketed."

However, treatments may avoid FDA regulation if the stem cells:

  • Came from your body
  • Aren't being tweaked to make tissue they don't normally make
  • Are only "minimally manipulated"

Transplanting such cells, clinics argue, is a surgical procedure rather than treatment with a drug or biological product. Licensed doctors can perform such transplants if they deem it medically appropriate for a patient.

"It is a gray area," says Mahendra Rao, MD, PhD, director of the National Institutes of Health's Center for Regenerative Medicine. "If you make too many health claims, it is still illegal. But if you do it correctly and there is validation to your work and you make your claims carefully, it is a surgical procedure not regulated by the FDA."

Because it's a gray area, Rao says, "certain groups try to see what they can drive through this window."

The FDA is stepping up its inspections of U.S. stem cell clinics and defending its actions in federal court. However, people can still find doctors and clinics in the U.S. who offer unproven stem-cell treatments.

"This is a very confusing time for patients. They have two questions: 'Can I do it?' and 'Should I do it?'" Hare says. "If the answer to 'Can I do it?' is yes, patients automatically assume the answer to 'Should I do it?' also is yes. And that can be dangerous."


"If you can't establish the benefits, you should not take the risk," Hare says.

Many stem cell clinics advertise that their procedures are safe. Since they are taking your own cells, concentrating them, and giving them back to you, what could be the harm?

"Let's say the therapy itself is completely neutral, no harm and no foul comes from it. You still are going through a medical procedure, going to a doctor's office, being put under anesthesia, getting liposuction, and then having the material injected back into you. And the first rule doctors learn is that there is no such thing as a benign procedure," Hare says.

Real Risks, Unknown Benefits

Every treatment has some risks. So the question comes down to whether the benefits outweigh the risks. And those studies haven't been done yet.

"The most patients can hope for is that the injection triggers some reaction in their bodies that has some benefit. And that is optimistic," Levine says. "The least-bad risk is financial harm from the costs of these treatments. But patients may also wind up sicker, because one thing about injecting cells is they stay in the body and may not do what they want. It's hard to know how harm is being done, because most of these clinics do not follow up on patients and have little incentive to do so."

Many patients claim they are much better or even cured by unorthodox stem cell treatments -- including some who received the same treatment as Ben Byer.

The procedure he underwent was -- and still is -- being advertised to patients, who must travel to China to get the treatment. It's not advertised as a stem-cell therapy, but uses stem-cell-like cells from aborted fetuses.

"The doctor took the cells, nurtured them in a test tube, and then injected them in two places in the brain and in the spinal cord, way up in a dangerous place," Byer says. "Remarkably, Ben survived the surgery."

Not all unapproved stem-cell treatments involve such risky surgery. A common technique gets stem cells from fat removed via liposuction. That's less risky than brain injections but is not without risk.


Byer, too, thought the early improvement he saw in his son meant the treatment was a success.

"I didn't realize it was a time-constrained benefit and that in a short time, Ben would be back to where he was," Byer says. "And during that short time I set up a whole operation to send literally hundreds of people to China. Even when I saw the benefits diminish over four weeks, and in the weeks after that, I didn't believe it. I told myself he'd recover those benefits. Then I told myself something else. By the time I faced up to it, it was too late."

WebMD Feature Reviewed by Michael W. Smith, MD on July 18, 2012



Stephen Byer.

Dawn Gusty, Kingston Springs, Tenn.

Joshua Hare, MD, director, Interdisciplinary Stem Cell Institute, University of Miami.

Mahendra Rao, MD, PhD, director, Center for Regenerative Medicine, National Institutes of Health, Bethesda, Md.

Aaron Levine, assistant professor, School of Public Policy, Georgia Institute of Technology, Atlanta.

Mary Laughlin, MD, professor of medicine, hematology, and oncology, University of Virginia, Charlottesville; and past president, International Society for Cellular Therapy.

FDA web site.

Sipp, D. Stem Cell Treatment Monitor web site, "More than Minimally Manipulative."

U.S. vs. Regenerative Sciences, LLC: "Order of Permanent Injunction."

News release, Regenexx web site.

IntelliCell web site.

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