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Hundreds of companies sell unapproved stem cell therapies in U.S.

Facelifts and breast enlargement, therapies for neurological diseases or sports injuries among unapproved uses

Thomson Reuters Posted: Jul 04, 2016 3:11 PM ET| Last Updated: Jul 04, 2016 3:11 PM ET

If you are considering stem cell treatment in the U.S., ask your doctor if the necessary FDA approval has been obtained or if you will be part of an FDA-regulated clinical study.
If you are considering stem cell treatment in the U.S., ask your doctor if the necessary FDA approval has been obtained or if you will be part of an FDA-regulated clinical study. (Advanced Cell Technology/Associated Press)

More than 300 companies are marketing unapproved stem cell procedures at more than 500 clinics in the U.S., according to a new study based on internet searches.

Found in embryos, umbilical cord blood and adult bone marrow, stem cells have the potential to develop into any type of specialized cell in the body.

Stem cells can be used to help repair areas damaged by disease or injury, according to the U.S. Department of Health and Human Services.
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In the U.S., stem cell therapies generally require U.S. Food and Drug Administration approval before they can be marketed, and the FDA has only approved one product so far, for blood disorders.

But many clinics in the U.S. now advertise a variety of stem cell treatments that have not been approved, ranging from cosmetic procedures like facelifts and breast enlargement, to therapies for neurological diseases or sports injuries, according to the new study.


If a place offers one treatment for 30 to 40 diseases, it's extremely unlikely that it's going to be effective.


- Leigh Turner

"Many of these marketing claims raise significant ethical issues given the lack of peer-reviewed evidence that advertised stem cell interventions are safe and efficacious for the treatment of particular diseases," the researchers write in the journal Cell Stem Cell.

Searching the internet, the researchers found 351 companies marketing unapproved stem cell procedures at 570 clinics in the U.S., most commonly in California, Florida, Texas, Colorado, Arizona and New York.

These procedures are not heavily regulated because they use cells from a patient's own body. But earlier this year, the FDA issued draft guidelines asserting that the stem cells used in most procedures are drugs and should require a rigorous approval process before they can be used. The draft guidelines will be discussed further at a public hearing in mid-September. http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm

http://www.cbc.ca/news/health/stem-cell-clinics-1.3663955