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Stem Cell Treatments: 6 False-Hope Warning Signs

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

6 Warning Signs continued...

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."

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