FDA Cracks Down on Illegal Stem Cell Treatments

Over the past decade, an unscrupulous stem cell industry that preys on vulnerable patients by offering modern-day snake oil has flourished. The number of clinics in the U.S. that peddle unproven stem cell “treatments” directly to consumers exploded from a handful in 2010 to as many as 570 in 2016.[1],[2]

Operated by for-profit companies, these clinics market stem cell injections for dozens of conditions, including Alzheimer’s disease, spinal cord injuries, joint damage and heart disease.[3] Some clinics offer stem cell injections for cosmetic uses, such as facelifts and breast augmentation.

However, the vast majority of these potentially dangerous stem cell therapies have never been shown to be safe or effective in well-designed clinical trials. Moreover, the stem cells used by these clinics — which often are extracted from a patient’s own fat tissue — are considered to be drugs and biologic products under Food and Drug Administration (FDA) regulations,[4] but the purveyors of these stem cell products, with few exceptions, have not obtained FDA approval to market them.

The FDA’s years-long failure to enforce regulations governing stem cell therapies emboldened for-profit stem cell clinics and fostered a regulatory environment characterized by some observers as a “Wild West”[5] and a “Cowboy Culture.”[6] But in late August, the FDA finally began to clamp down on the marketing of illegal stem cell treatments when it took two enforcement actions against stem cell clinics.

First, on August 24, 2017, the FDA issued a warning letter to US Stem Cell Clinic in Sunrise, Florida for illegally marketing stem cell products derived from patients’ fat tissue.[7] The company had promoted its stem cell therapies for a variety of diseases, including Parkinson’s disease, diabetes and chronic obstructive pulmonary disease. The agency publicly declared that US Stem Cell Clinic had marketed stem cell products “without FDA approval” and had deviated significantly “from current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk.”[8]

Then, on August 28, 2017, the FDA announced that the agency had taken “decisive action to prevent the use of a potentially dangerous and unproven treatment belonging to StemImmune Inc. in San Diego, California, and administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California.”[9] Three days earlier, U.S. Marshals — on behalf of the FDA — had seized vials of smallpox vaccine, which was being used inappropriately to create an “unapproved” stem cell product for treating vulnerable cancer patients.

US Stem Cell Clinic and California Stem Cell Treatment Centers represent only the tip of the iceberg in this troubling industry. The FDA must relentlessly pursue and shut down all stem cell clinics that market unsafe and unproven therapies.

References

[1] Associated Press. Stem cell clinics run amok amid lack of regulation. The Mercury News. May 18, 2015 (updated August 12, 2016). http://www.mercurynews.com/2015/05/18/stem-cell-clinics-run-amok-amid-lack-of-regulation/. Accessed September 19, 2017.

[2] Turner L, Knoepfler P. Selling stem cells in the USA: Assessing the direct-to-consumer industry. Cell Stem Cell. 2016;19(2):154-157.

[3] Ibid.

[4] Food and Drug Administration. Warning letter to US Stem Cell Clinic. August 24, 2017. https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm573187.htm. Accessed September 19, 2017.

[5] Associated Press. Stem cell clinics run amok amid lack of regulation. The Mercury News. May 18, 2015 (updated August 12, 2016). http://www.mercurynews.com/2015/05/18/stem-cell-clinics-run-amok-amid-lack-of-regulation/. Accessed September 19, 2017.

[6] Cyranoski D. Cowboy culture. Nature. 2013;494(7436):166-168.

[7] Food and Drug Administration. Warning letter to US Stem Cell Clinic. August 24, 2017. https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm573187.htm. Accessed September 19, 2017.

[8] Food and Drug Administration. FDA news release: FDA warns US Stem Cell Clinic of significant deviations. August 28, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573431.htm. Accessed September 19, 2017.

[9] Food and Drug Administration. FDA news release: FDA acts to remove unproven, potentially harmful treatment used in ‘stem cell’ centers targeting vulnerable patients. August 28, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573427.htm. Accessed September 19, 2017.