In US, unlicensed stem cell clinic numbers keep climbing

Regulatory NewsRegulatory News | 04 November 2021 |  By 

Stem cells. Image credit: NIH

Nearly 1,500 US businesses were engaged in direct-to-consumer marketing of unproven and unlicensed stem cell therapies in 2021, marking a significant uptick over the last five years.
The figure comes from an analysis published in the journal Cell Stem Cell that breaks down the number of clinics promoting various types of putative stem cell treatments in the United States between 2016 and 2021. As of March 31, 2021, there were 1,480 U.S. business operating 2,754 clinics that were directly marketing these stem cell therapies. In 2016, there had been just 351 businesses and 570 clinics selling these products, according to findings from an earlier analysis that utilized less expansive search techniques.
“There has been, over the last five years, dramatic expansion of the marketplace in a way that’s quite surprising,” Leigh Turner, PhD, author of the analysis and a professor of health, society, and behavior at the University of California, Irvine, told Focus. While some businesses have exited the marketplace due to FDA enforcement activities, those departures have been far outnumbered by the entrance of new businesses, he said.
Profits, lack of enforcement drive increase
The proliferation of businesses and clinics offering unlicensed stem cell therapies may be driven by multiple factors, Turner explained, including profitability, the normalization of advertising around stem cell therapies, and the “lack of a robust response” by U.S. regulators.
In 2021, the most common therapies advertised were autologous bone-marrow-derived stem cell interventions, but other therapies included allogeneic birth-tissue-derived stem cell products and mesenchymal stem cell treatments. A few clinics offered xenogeneic stem cell products, embryonic stem cells, and “very small embryonic like” stem cells. Another emerging treatment – stem cell derived exosome products – was advertised by about 6% of businesses.
More than 85% of the businesses marketing these therapies claim that they treat pain, with about 47% making claims related to orthopedic conditions, according to the analysis. A smaller number of companies advertise their stem cell products as treatments for neurological diseases, immunological conditions, lung conditions, and paralysis. About 1.5% of the companies made claims that their products could treat children with cerebral palsy or autism.
In most cases, the costs of the stem cell treatments were not disclosed online, but among the 56 businesses that did list prices, advertised treatment costs ranged from $1,200 to $28,000.
FDA guidance exists, but is ignored
The expansion of the U.S. marketplace for unlicensed stem cell therapies is happening despite regulatory activity by the US Food and Drug Administration (FDA), Turner explained.
In 2017, the agency announced plans for a regulatory framework around regenerative medicine therapies and began a period of enforcement discretion that targeted the most egregious actors in the marketplace. (RELATED: FDA to Unveil New Regulatory Framework for Stem Cell Therapies, Regulatory Focus 28 August 2017)
In 2019, FDA sought to step up its enforcement activity and finalized guidance around the regulatory considerations for stem cell products with minimal manipulation and homologous use, as well as offering additional information on the same surgical procedure exception and the expedited programs for regenerative medicine therapies for serious conditions. (RELATED: FDA to Step Up Stem Cell Enforcement, Look Into Pathway for Low-Risk Treatments, Regulatory Focus 03 April 2019)
Turner praised the agency for having detailed regulations and guidance and being transparent about how they interpret and apply them. “The problem seems to be more on the side of regulatory enforcement,” he said, noting that businesses marketing unlicensed stem cell therapies know that the odds are they will not be subject to regulatory action even if they are in violation of existing regulations.
To step up enforcement to a level with the potential to shrink the unlicensed therapy marketplace, FDA needs to coordinate to a far greater extent with other regulators, Turner said, including the Department of Justice, the Federal Trade Commission, state attorneys general, as well as state legislatures and medical boards.
“I think if some people lost their licenses to practice medicine, that would have an impact,” Turner said.
The research was supported by The Pew Charitable Trusts.
Cell Stem Cell article


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