Stem Cell Treatments: 6 False-Hope Warning Signs
Unproven, Risky Treatments Mislead Patients to Seek Cutting-Edge Therapy
Stem Cell Treatments and the FDA continued...
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."