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

A examine printed by Stem Cell Reviews, an open entry discussion board, recognized 38 companies promoting purported stem cell interventions and exosome merchandise for COVID-19, and analyzed their direct-to-consumer (DTC) internet advertising claims.¹

These firms operated or supplied entry to 60 clinics. Greater than 75% of those clinics have been primarily based within the US and Mexico. Thirty-six of the companies marketed their stem cell and exosome merchandise as therapies for Lengthy COVID, six marketed them as “immune boosters,” 5 claimed to deal with sufferers within the acute an infection section, and two claimed their merchandise have been preventive.¹

The least costly product price $2,950, the costliest was $25,000, and the common listed price for sufferers was $11,322. The promotion of those merchandise is regarding as a result of they haven’t been accepted by nationwide regulators and don’t look like supported by convincing security and efficacy knowledge.¹

Companies promoting colloidal silver, vitamin-based “immune boosters,” echinacea, elderberry elixir, ozone and hyperbaric oxygen remedy, important oils, cannabidiol merchandise, natural teas, Thymosin Alpha-1, and different purported therapies have used on-line direct-to-consumer promoting instruments to draw prospects.^2-4 Corporations promoting believed stem cell therapies and exosome therapies are among the many entities selling merchandise that haven’t been accepted to be used or approved for emergency use by the FDA and different nationwide regulators.

Inside the world market of companies engaged in DTC promoting of stem cell interventions and exosome merchandise for a variety of illnesses and accidents, some firms have tailor-made their gross sales pitches to the pandemic and now market these interventions as therapies for COVID-19.⁵ Their shoppers have included people hoping to keep away from an infection by the SARS-CoV-2 virus, sufferers in search of remedy through the acute section of COVID-19 an infection, and people in search of reduction from signs labeled utilizing such diagnostic classes as “Lengthy COVID,” “Submit-Acute COVID-19 Syndrome” (PACS), and “Submit-COVID.” ^6-8 Such claims have prompted issues about affected person security, misleading promoting representations, exploitation of susceptible individuals, and deceptive appropriation of credible scientific analysis.⁹ This examine examines this troubling market by analyzing on-line representations made by companies promoting stem cell-based interventions and exosome merchandise as purported therapies or preventive measures for COVID-19.

Some nationwide regulatory our bodies have additionally gotten concerned within the matter of companies promoting unapproved and unproven stem cell-based interventions or exosome merchandise for COVID. This included the US Federal Commerce Fee (FTC), who issued warning letters to firms promoting such merchandise, and the FDA has additionally issued warning letters and untitled letters to companies.⁵

The evaluation additionally alludes to a clinician dealing with penalties for involvement, noting that “Not less than one clinician in america was convicted of federal fees related to advertising and marketing stem cell merchandise as therapies for COVID-19, and state Attorneys Normal Workplaces have additionally sued companies utilizing alleged misrepresentations to promote such merchandise. Acknowledging these essential enforcement actions, different companies appeared to have averted attracting the eye of regulatory our bodies regardless of utilizing apparently deceptive claims to promote stem cell-based interventions and exosome merchandise as putative therapies for COVID-19. This exercise suggests the significance of continued vigilance by organizations such because the Meals and Drug Administration, Federal Commerce Fee, and different nationwide regulators.”

References

1. Turner L., et al. Companies advertising and marketing purported stem cell therapies and exosome therapies for COVID-19: An evaluation of direct-to-consumer internet advertising claims. Stem Cell Reviews. Printed October 26, 2023. DOI :https://doi.org/10.1016/j.stemcr.2023.09.015. Accessed November 14, 2023.

2. Bramstedt Okay.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 web: a content material evaluation of Google searchresults. BMJ Open. 2020; 10: e040989

4. Tran, A.; Sheikhan N.Y.; Sheikhan T.; Nowak D.A.; Witek Jr., T.J. Unsubstantiated well being claims for COVID-19 infections are led by cannabidiol: return of snake oil medication.J. Hashish 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: Companies Promoting Unproven and Unlicensed “Stem Cell Remedies” 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. Lengthy-term Well being Penalties of COVID-19.JAMA. 2020; 324: 1723-1724. https://doi.org/10.1001/jama.2020.19719

7. Groff, D.; Solar, 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. Brief-term and Lengthy-term Charges of Postacute Sequelae of SARS-CoV-2 An infection: A Systematic Evaluation. JAMA Netw. Open. 2021; 4e2128568 https://doi.org/10.1001/jamanetworkopen.2021.28568

8. Nalbandian, A.; Sehgal, Okay.; Gupta, A.; Madhavan, M.V.; McGroder, C.; Stevens, J.S.; Prepare dinner, J.R.; Nordvig, A.S.; Shalev, D.;Sehrawat T.S. et al.Submit-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 promote in 2021: U.S. companies promoting unlicensed and unproven stem cell interventions. Cell Stem Cell. 2021; 28: 1891-1895. https://doi.org/10.1016/j.stem.2021.10.008