Open Access Forum Analyzes COVID-19 Stem Cell and Exosome Therapies

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A study published by Stem Cell Reports, an open access forum, identified 38 businesses advertising purported stem cell interventions and exosome products for COVID-19, and analyzed their direct-to-consumer (DTC) online advertising claims.¹

These companies operated or provided access to 60 clinics. More than 75% of these clinics were based in the US and Mexico. Thirty-six of the businesses marketed their stem cell and exosome products as treatments for Long COVID, six advertised them as “immune boosters,” five claimed to treat patients in the acute infection phase, and two claimed their products were preventive.¹

The least expensive product cost $2,950, the most expensive was $25,000, and the average listed cost for patients was $11,322. The promotion of these products is concerning because they have not been approved by national regulators and do not appear to be supported by convincing safety and efficacy data.¹

Businesses selling colloidal silver, vitamin-based “immune boosters,” echinacea, elderberry elixir, ozone and hyperbaric oxygen therapy, essential oils, cannabidiol products, herbal teas, Thymosin Alpha-1, and other purported therapies have used online direct-to-consumer advertising tools to attract customers.^2-4 Companies selling believed stem cell treatments and exosome therapies are among the entities promoting products that have not been approved for use or authorized for emergency use by the FDA and other national regulators.

Within the global marketplace of businesses engaged in DTC advertising of stem cell interventions and exosome products for a wide range of diseases and injuries, some companies have tailored their sales pitches to the pandemic and now market these interventions as treatments for COVID-19.⁵ Their clients have included individuals hoping to avoid infection by the SARS-CoV-2 virus, patients seeking treatment during the acute phase of COVID-19 infection, and individuals seeking relief from symptoms classified using such diagnostic categories as “Long COVID,” “Post-Acute COVID-19 Syndrome” (PACS), and “Post-COVID.” ^6-8 Such claims have prompted concerns about patient safety, deceptive advertising representations, exploitation of vulnerable persons, and misleading appropriation of credible scientific research.⁹ This study examines this troubling marketplace by analyzing online representations made by businesses advertising stem cell-based interventions and exosome products as purported treatments or preventive measures for COVID-19.

Some national regulatory bodies have also gotten involved in the matter of businesses selling unapproved and unproven stem cell-based interventions or exosome products for COVID. This included the US Federal Trade Commission (FTC), who issued warning letters to companies selling such products, and the FDA has also issued warning letters and untitled letters to businesses.⁵

The analysis also alludes to a clinician facing penalties for involvement, noting that “At least one clinician in the United States was convicted of federal charges connected to marketing stem cell products as treatments for COVID-19, and state Attorneys General Offices have also sued businesses using alleged misrepresentations to sell such products. Acknowledging these important enforcement actions, other businesses appeared to have avoided attracting the attention of regulatory bodies despite using apparently misleading claims to sell stem cell-based interventions and exosome products as putative treatments for COVID-19. This activity suggests the importance of continued vigilance by organizations such as the Food and Drug Administration, Federal Trade Commission, and other national regulators.”

References

1. Turner L., et al. Businesses marketing purported stem cell treatments and exosome therapies for COVID-19: An analysis of direct-to-consumer online advertising claims. Stem Cell Reports. Published October 26, 2023. DOI :https://doi.org/10.1016/j.stemcr.2023.09.015. Accessed November 14, 2023.

2. Bramstedt K.A.Unicorn Poo and Blessed Waters: COVID-19 Quackery and FDA Warning Letters.Ther. Innov. Regul. Sci. 2021; 55: 239-244. https://doi.org/10.1007/s43441-020-00224-1

3. Rachul C.; Marcon A.R.; Collins B.; Caulfield T. COVID-19 and ‘immune boosting’ on the internet: a content analysis of Google searchresults. BMJ Open. 2020; 10: e040989

4. Tran, A.; Sheikhan N.Y.; Sheikhan T.; Nowak D.A.; Witek Jr., T.J. Unsubstantiated health claims for COVID-19 infections are led by cannabidiol: return of snake oil medicine.J. Cannabis Res. 2021; 3: 49 https://doi.org/10.1186/s42238-021-00109-6

5. Turner, L. Preying on Public Fears and Anxieties in a Pandemic: Businesses Selling Unproven and Unlicensed “Stem Cell Treatments” for COVID-19. Cell Stem Cell. 2020; 26: 806-810. https://doi.org/10.1016/j.stem.2020.05.003

6. Del Rio, C.; Collins, L.F.; Malani P. Long-term Health Consequences of COVID-19.JAMA. 2020; 324: 1723-1724. https://doi.org/10.1001/jama.2020.19719

7. Groff, D.; Sun, A.; Ssentongo, A.E.; Ba ,D.M.; Parsons, N.; Poudel, G.R.; Lekoubou, A.; Oh, J.S;. Ericson, J.E.; Ssentongo, P.; Chinchilli, V.M. Short-term and Long-term Rates of Postacute Sequelae of SARS-CoV-2 Infection: A Systematic Review. JAMA Netw. Open. 2021; 4e2128568 https://doi.org/10.1001/jamanetworkopen.2021.28568

8. Nalbandian, A.; Sehgal, K.; Gupta, A.; Madhavan, M.V.; McGroder, C.; Stevens, J.S.; Cook, J.R.; Nordvig, A.S.; Shalev, D.;Sehrawat T.S. et al.Post-acute COVID-19 syndrome. Nat. Med. 2021; 27: 601-615. https://doi.org/10.1038/s41591-021-01283-z

9. Turner, L. The American stem cell sell in 2021: U.S. businesses selling unlicensed and unproven stem cell interventions. Cell Stem Cell. 2021; 28: 1891-1895. https://doi.org/10.1016/j.stem.2021.10.008