Uncovering the gray zone: mapping the global landscape of direct-to-consumer businesses offering interventions based on secretomes, extracellular vesicles, and exosomes

Atiyeh Asadpour; Badrul Hisham Yahaya; Katrina Bicknell; Graeme S Cottrell; Darius Widera

doi:10.1186/s13287-023-03335-2

Uncovering the gray zone: mapping the global landscape of direct-to-consumer businesses offering interventions based on secretomes, extracellular vesicles, and exosomes

Stem Cell Res Ther. 2023 May 4;14(1):111. doi: 10.1186/s13287-023-03335-2.

Authors

Atiyeh Asadpour¹, Badrul Hisham Yahaya², Katrina Bicknell³, Graeme S Cottrell⁴, Darius Widera⁵

Affiliations

¹ Stem Cell Biology and Regenerative Medicine Group, School of Pharmacy, University of Reading, PO Box 226, Whiteknights, Reading, RG6 6AP, UK.
² Lung Stem Cell and Gene Therapy Group, Department of Biomedical Sciences, Advanced Medical and Dental Institute (IPPT), Universiti Sains Malaysia, Sains@Bertam, 13200, Kepala Batas, Penang, Malaysia.
³ School of Pharmacy, University of Reading, PO Box 226, Whiteknights, Reading, RG6 6AP, UK.
⁴ Cellular and Molecular Neuroscience, School of Pharmacy, University of Reading, PO Box 226, Whiteknights, Reading, RG6 6AP, UK.
⁵ Stem Cell Biology and Regenerative Medicine Group, School of Pharmacy, University of Reading, PO Box 226, Whiteknights, Reading, RG6 6AP, UK. d.widera@reading.ac.uk.

Abstract

Background: The last decade has seen a significant increase in media attention, industrial growth, and patient interest in stem cell-based interventions. This led to a rise in direct-to-consumer businesses offering stem cell "therapies" for multiple indications with little evidence of safety and efficacy. In parallel, the use of stem cell secretomes as a substitute for stem cell transplantation has become an increasing trend in regenerative medicine with multiple clinical trials currently assessing their efficacy and safety profile. As a result, multiple businesses and private clinics have now started to exploit this situation and are offering secretome-based interventions despite the lack of supporting data. This poses significant risks for the patients and could lead to a credibility crisis in the field.

Methods: Internet searches were used to locate clinics marketing and selling interventions based on stem cell secretomes, exosomes, or extracellular vesicles. Data were extracted from websites with a particular focus on the global distribution of the businesses, the cellular source of the secretome, the indication spectrum, and the pricing of the provided services. Lastly, the types of evidence used on the websites of the businesses to market their services were extracted.

Results: Overall, 114 companies market secretome-based therapies in 28 countries. The vast majority of the interventions are based on allogenic stem cells from undisclosed cellular sources and skin care is the most marketed indication. The price range is USD99-20,000 depending on the indication.

Conclusions: The direct-to-consumer industry for secretome-based therapies appears to be primed for growth in the absence of appropriate regulatory frameworks and guidelines. We conclude that such business activity requires tight regulations and monitoring by the respective national regulatory bodies to prevent patients from being conned and more importantly from being put at risk.

Keywords: Community health; Direct-to-consumer-businesses; Exosomes; Extracellular vesicles; Regenerative medicine; Secretome; Stem cells.

MeSH terms

Exosomes*
Extracellular Vesicles*
Humans
Regenerative Medicine
Secretome
Stem Cells