Beware of unproven stem cell therapies
The FDA says that stem cell products may offer the potential to treat many medical conditions and diseases for which few alternative treatments exist, but almost all of them have yet to be proven to be effective or safe. That hasn’t stopped unscrupulous medical professionals and other promoters from touting them as miracle cures.
Stem cells are sometimes called the body’s “master cells” because they develop into blood, brain, bones and the body’s other organs. Stem cells that come from bone marrow or blood are routinely used to treat cancer and other disorders of the blood and immune system. But other uses, including treating COVID-19, have not been properly studied under an FDA Investigational New Drug Application, which includes providing sufficient data from human clinical testing to help evaluate a product’s potential risks.
The FDA cites these potential safety concerns for unproven treatments:
- Administration site reactions,
- The ability of cells to move from placement sites and change into inappropriate cell types or multiply,
- Failure of cells to work as expected, and
- The growth of tumors.
There are safety risks even with your own stem cells and contamination can occur if cells are manipulated after removal.
The FTC and Georgia Attorney General sued the co-founders of the Stem Cell Institute of America for allegedly targeting seniors with bogus claims that its therapy could treat arthritis, joint pain and other orthopedic ailments. The agencies said the company also claimed its stem cell therapy is comparable or superior to surgery, steroid injections and painkillers. A related company trained chiropractors and other healthcare practitioners in making similar claims. They also hosted free “educational seminars” for consumers at which they promoted injections that cost approximately $5,000 per joint, with many patients receiving multiple injections.
This wasn’t the FTC’s first enforcement action against deceptive stem cell therapy claims. In 2018, a California physician and his companies settled with the FTC over claims their “amniotic stem cell therapy” could treat Parkinson’s disease, autism, macular degeneration, cerebral palsy, multiple sclerosis, heart attacks and a host of other serious ailments. The defendants earned at least $3.3 million offering injections that cost up to $15,000.
The only stem cell products approved by the FDA for use in the United States consist of blood-forming stem cells derived from umbilical cord blood. They’re approved for limited use in patients with disorders that affect the production of blood.
In bringing the most recent action, the Acting Director of the FTC’s Bureau of Consumer Protection said, “At best, the use of unproven products or therapies can cost consumers thousands of dollars without affording them any results. At worst, it can be harmful to their health.”
If you’re considering a stem cell treatment, the FDA says to make sure it’s FDA-approved or being studied under an Investigational New Drug Application. The FTC and BBB offer these additional tips:
- Stem cell products and therapies may be referred to as “regenerative medicine.”
- Think critically about any claims you see, particularly concerning health care.
- Don’t trust a website simply because it looks professional, uses medical terms, or has success stories that could be made up.
- Check out the company and treatment online using terms like “scam,” “complaints” and “reviews.
- Consult with a trusted health care provider before using any products or treatments.
Randy Hutchinson is the president of the Better Business Bureau of the Mid-South. Reach the BBB at 800-222-8754.