Released by the Florida Consumer e-Newsletter …
The Food and Drug Administration (FDA) is warning consumers to get all the facts before considering stem cell treatments. Stem cells are the cells that develop into bones, blood, brains and all of the body’s organs. Stem cell therapies have the potential to treat diseases that currently have few treatment options. Unfortunately, some unscrupulous clinics offer stem cell treatments promising miracle cures that are both unproven and unapproved by the FDA.
The FDA is increasing its enforcement to protect consumers from dishonest stem cell clinics, while continuing to encourage reputable research to harness the lifesaving potential of these cells. As of today, the only stem cell products approved for use in the United States are blood-forming stem cells.
To do your part to stay safe, make sure that any stem cell treatment you are considering is either:
- FDA-approved, or;
- Being studied under an Investigational New Drug Application (IND), which is a clinical investigation plan submitted and allowed to proceed by the FDA.
The FDA shared the following advice if you’re considering stem cell treatment in the United States:
- Ask if the FDA has reviewed the treatment. Ask your health care provider to confirm this information. You also can ask the clinical investigator to give you the FDA-issued Investigational New Drug Application (IND) number and the chance to review the FDA communication acknowledging the IND. Ask for this information before getting treatment�even if the stem cells are your own.
- Request the facts and ask questions if you don’t understand. To participate in a clinical trial that requires an IND application, you must sign a consent form that explains the experimental procedure. The consent form also identifies the Institutional Review Board (IRB) that assures the protection of the rights and welfare of human subjects. Make sure you understand the entire process and known risks before you sign. You also can ask the study sponsor for the clinical investigator’s brochure, which includes a short description of the product and information about its safety and effectiveness.
If you’re considering stem cell treatment in another country:
- Learn about regulations that cover products in that country.
- Know that the FDA does not have oversight of treatments done in other countries. The FDA typically has little information about foreign establishments or their stem cell products.
- Be cautious. If you’re considering a stem cell-based product in a country that may not require regulatory review of clinical studies, it may be hard to know if the experimental treatment is reasonably safe.
To learn more visit:https://www.fda.gov/consumers/consumer-updates/fda-warns-about-stem-cell-therapies