Uncovering the gray zone: mapping the global landscape of direct-to-consumer businesses offering interventions based on secretomes, extracellular vesicles, and exosomes
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...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-05-01
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| Series: | Stem Cell Research & Therapy |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13287-023-03335-2 |
| _version_ | 1797832216480317440 |
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| author | Atiyeh Asadpour Badrul Hisham Yahaya Katrina Bicknell Graeme S. Cottrell Darius Widera |
| author_facet | Atiyeh Asadpour Badrul Hisham Yahaya Katrina Bicknell Graeme S. Cottrell Darius Widera |
| author_sort | Atiyeh Asadpour |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-09T14:04:15Z |
| format | Article |
| id | doaj.art-4ed3126082e54f7daef957e93c82d92a |
| institution | Directory Open Access Journal |
| issn | 1757-6512 |
| language | English |
| last_indexed | 2024-04-09T14:04:15Z |
| publishDate | 2023-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Stem Cell Research & Therapy |
| spelling | doaj.art-4ed3126082e54f7daef957e93c82d92a2023-05-07T11:07:16ZengBMCStem Cell Research & Therapy1757-65122023-05-011411710.1186/s13287-023-03335-2Uncovering the gray zone: mapping the global landscape of direct-to-consumer businesses offering interventions based on secretomes, extracellular vesicles, and exosomesAtiyeh Asadpour0Badrul Hisham Yahaya1Katrina Bicknell2Graeme S. Cottrell3Darius Widera4Stem Cell Biology and Regenerative Medicine Group, School of Pharmacy, University of ReadingLung Stem Cell and Gene Therapy Group, Department of Biomedical Sciences, Advanced Medical and Dental Institute (IPPT), Universiti Sains MalaysiaSchool of Pharmacy, University of ReadingCellular and Molecular Neuroscience, School of Pharmacy, University of ReadingStem Cell Biology and Regenerative Medicine Group, School of Pharmacy, University of ReadingAbstract 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.https://doi.org/10.1186/s13287-023-03335-2Stem cellsExosomesSecretomeExtracellular vesiclesDirect-to-consumer-businessesCommunity health |
| spellingShingle | Atiyeh Asadpour Badrul Hisham Yahaya Katrina Bicknell Graeme S. Cottrell Darius Widera Uncovering the gray zone: mapping the global landscape of direct-to-consumer businesses offering interventions based on secretomes, extracellular vesicles, and exosomes Stem Cell Research & Therapy Stem cells Exosomes Secretome Extracellular vesicles Direct-to-consumer-businesses Community health |
| title | Uncovering the gray zone: mapping the global landscape of direct-to-consumer businesses offering interventions based on secretomes, extracellular vesicles, and exosomes |
| title_full | Uncovering the gray zone: mapping the global landscape of direct-to-consumer businesses offering interventions based on secretomes, extracellular vesicles, and exosomes |
| title_fullStr | Uncovering the gray zone: mapping the global landscape of direct-to-consumer businesses offering interventions based on secretomes, extracellular vesicles, and exosomes |
| title_full_unstemmed | Uncovering the gray zone: mapping the global landscape of direct-to-consumer businesses offering interventions based on secretomes, extracellular vesicles, and exosomes |
| title_short | Uncovering the gray zone: mapping the global landscape of direct-to-consumer businesses offering interventions based on secretomes, extracellular vesicles, and exosomes |
| title_sort | uncovering the gray zone mapping the global landscape of direct to consumer businesses offering interventions based on secretomes extracellular vesicles and exosomes |
| topic | Stem cells Exosomes Secretome Extracellular vesicles Direct-to-consumer-businesses Community health |
| url | https://doi.org/10.1186/s13287-023-03335-2 |
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