November 10, 2021
A report published recently in Cell Stem Cell found that nearly 1,500 businesses advertise stem cell therapies that do not have a Food and Drug Administration-approved biologics license application (BLA) or investigational new drug (IND) application. To lawfully administer and market these products, a firm must have a valid BLA or IND, as specified by FDA regulations.
Between 2016 and 2021, investigators conducted online queries using an array of search terms to examine the current state of the American marketplace for putative stem cell treatments. They also used data mining on company websites and content analysis to document these marketing representations. Their report analyzed the number of these businesses and where they are located, which stem cell products they advertise, the types of diseases and injuries they purport to treat, the prices they charge, and what types of companies operate in this space.
The report identified 1,480 businesses operating 2,754 clinics engaged in direct-to-consumer marketing of purported stem cell therapies for a variety of diseases and injuries. California, Florida and Texas had the largest number of these clinics, with 347, 333 and 310 operating in each state, respectively. As Texas has a larger population than Florida, investigators noted that population does not appear to be the sole factor determining the geographic distribution of clinics.
Autologous stem cell-based products were the most commonly advertised interventions: 671 (45.3) businesses advertised autologous bone marrow-derived stem cell interventions, 437 (29.5%) advertised autologous adipose-derived stem cell products, and 42 businesses (2.8%) advertised autologous stem cell interventions reportedly obtained from peripheral blood.
Among allogeneic products, 350 businesses (23.6%) advertised umbilical cord blood- or tissue-derived stem cells, 260 (17.6%) advertised amniotic stem cell products, and 47 (3.2%) advertised placental stem cell products. Twenty-five businesses (1.68%) advertised allogeneic stem cell products with no source specified. Nearly 600 businesses advertised mesenchymal stem cell ‘‘treatments.’’ The survey also identified businesses that advertise xenogeneic stem cell products, embryonic stem cells, ‘‘very small embryonic-like’’ stem cells, and stem cell-derived exosome products.
These businesses made an array of claims about the diseases and conditions their products treat. Investigators found that the most common marketing representation was treatment for pain relief (1,262, 85.3%), followed by treatment for orthopedic diseases and injuries (689, 46.7%), sports injuries (339, 22.9%), neurological diseases (134, 9.1%) and immunological conditions (95, 6.4%).
Of the 1,480 businesses identified in the study, only 335 (22.6%) identified themselves as stem cell clinics. Most businesses did not explicitly brand themselves as stem cell companies or clinics. Instead, they advertised stem cell interventions among a range of listed therapies. Only 56 companies advertised their prices. The lowest advertised price was $1,200; the highest was $28,000. The average rate was $5,118, and the median price was $4,000.
Compared with 2016, investigators found a four-fold increase in the number of businesses and clinics selling unlicensed and unproven stem cell products in 2021. While expanded and refined search techniques likely played a role in identifying businesses and clinics during the study period, they believe the larger figures appear to be attributable in part to substantial marketplace expansion.
Furthermore, the authors noted that much of the influx of new businesses and clinics occurred during a period of enforcement discretion by FDA, which was intended to provide time for businesses to determine whether their stem cell products require FDA premarketing approval. While the period of enforcement discretion has ended, the authors concluded that the possibility of increased enforcement activity by the FDA does not appear to have deterred most of the businesses identified in this study from continuing to market purported stem cell therapies.
“This trend seems likely to continue absent substantial increases in enforcement activity by FDA, FTC, and other regulatory bodies and law enforcement agencies,” the researchers wrote.