The deadly business of an unregulated global stem cell industry

Lysaght, Tamra; Lipworth, Wendy; Hendl, Tereza; Kerridge, Ian; Lee, Tsung Ling; Munsie, Megan; Waldby, Catherine; Stewart, Cameron

doi:10.1136/medethics-2016-104046

Cited by 38 publications

(21 citation statements)

References 16 publications

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“…Mainstream scientific influencers have argued that uninformed patients and health consumers may be exploited if appropriate regulatory oversight is not imposed and implemented for so-called unproven stem cell interventions. Stronger regulation and oversight, they argue, are needed to protect patients' and consumers' health, mitigate risks, and safeguard informed choice (Regenberg et al, 2009;ISSCR, 2010;McLean et al, 2015;Lysaght et al, 2017).…”

Section: Analytical Perspectives: Medical Knowledge (Making) In the Dmentioning

confidence: 99%

“…Critical commentaries calling for stronger regulation and customer protection around such therapies have multiplied (e.g. Regenberg et al, 2009;ISSCR, 2010;McLean et al, 2015;Lysaght et al, 2017;Sipp, 2017). The success of commercial stem cell businesses suggests that large numbers of health consumers are nonetheless choosing to undergo experimental stem cell interventions marketed online, directly contravening healthcare authorities' advice.…”

Section: Introductionmentioning

confidence: 99%

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Marketing Experimental Stem Cell Therapies in the UK: Biomedical Lifestyle Products and the Promise of Regenerative Medicine in the Digital Era

2019

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Stem cell research has attracted much public and biomedical anticipation centred on the possibility of using stem cells to treat various diseases and conditions, but the number of evidence-based therapies is currently limited. Numerous commercial direct-to-consumer (DTC) businesses are nonetheless marketing experimental stem cell therapies online for myriad medical conditions and aesthetic ailments, which has attracted critique due to safety and efficacy concerns. Existing research has largely focused on the problem of unproven therapies and regulatory pathways for addressing it. The proliferation of these experimental products must also be examined, however, in the broader socio-technological context of consumer culture and changing practices of knowledge-making in the digital era. DTC stem cell therapies have emerged as a new biomedical 'lifestyle' product that blurs the boundaries between 'science,' 'medicine,' and 'consumer culture.' In using, conceptualising and marketing stem cells, commercial businesses build on and commercially co-opt alternative epistemic and ontological frames that challenge scientific medicine. They advance promissory narratives about their potential that tap on cultural aspirations around the future of medicine and health. This is key, not only for understanding how and why these therapies have proliferated but also in conceptualising what the 'problem' around them actually is.

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Section: Analytical Perspectives: Medical Knowledge (Making) In the Dmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Marketing Experimental Stem Cell Therapies in the UK: Biomedical Lifestyle Products and the Promise of Regenerative Medicine in the Digital Era

2019

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“…Is it possible that some pa-tients classified as having a superficial infection did not really have an SSI? The authors used the US Centers for Disease Control and Prevention (CDC) criteria for superficial and deep infections, 5 in which local cellulitis, stitch abscesses, and pin site infections are not considered SSIs. Of 58 patients in the superficial infection group, only 2 had surgery to address it, and 9 were managed without antibiotics, which would argue against a true SSI.…”

Section: Antibiotic Prophylaxis For Removal Of Lower Leg Orthopedic Imentioning

confidence: 99%

Crowdfunding for Unproven Stem Cell–Based Interventions

Snyder

Turner

Crooks

2018

JAMA

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Because insurers typically will not pay for unproven stem cell interventions, patients seeking these services must purchase them out-of-pocket or use alternative funding mechanisms such as crowdfunding (ie, using online social networks to solicit donations). 1 Crowdfunding for stem cell interventions raises questions concerning how their benefits and risks are depicted in crowdfunding campaigns. Given the increasing visibility and prevalence of health-related crowdfunding, it is important to understand how such interventions are described by campaigners to potential donors.

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“…It is known that after intravenous administration of MSCs, they are initially trapped in the lungs (Fischer et al, 2009;Eggenhofer et al, 2012;Prologo et al, 2016). Intravenous infusion of ASCs is safe (Ra et al, 2011a;Ra et al, 2011b;Kang and Park, 2014), but cryopreserved or freshly thawed cells may cause a potential risk of pulmonary embolism, oedema, and even death (Furlani et al, 2009;Cyranoski, 2010;Jung et al, 2013;Tatsumi et al, 2013;Lysaght et al, 2017). It could be provoked by the aggregate formation in blood vessels as well as the response of the complement and immune system to infused ASCs (Eggenhofer et al, 2014;Moll and Le Blanc, 2015).…”

Section: Introductionmentioning

confidence: 99%

Characterisation and In Vivo Safety of Canine Adipose-Derived Stem Cells

Bērziņš

Matise-VanHoutana

Pētersone

et al. 2018

Proceedings of the Latvian Academy of Sciences. Section B. Natural, Exact, and Applied Sciences.

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The study characterises canine adipose-derived stem cells (cASCs) in comparison to human ASCs (hASCs) and tests their safety in a canine model after intravenous administration. cASCs from two dogs were cultured under hypoxic conditions in a medium supplemented with autologous serum. They were plastic adherent, spindle-shaped cells that expressed CD73, CD90, and CD44 but lacked CD45, CD14, HLA-DR, and CD34. cASCs differentiated toward adipogenic, osteogenic, and chondrogenic lineages, although adipogenic differentiation capacity was low. Blast transformation reaction demonstrated that these cells significantly suppress T-cell proliferation, and this ability is dose-dependent. Intravenous administration of a cell freezing medium, therapeutic dose of cASCs (2 × 106 live cells/kg), and five times higher dose of cASCs showed no significant side effects in two dogs. Microscopic tissue lesions were limited to only mild, non-specific changes. There were no signs of malignancy. The results of the study indicate that cASCs are similar to hASCs and are safe for therapeutic applications in a canine model. The proposed methodology for ASC preparation on a non-routine basis, which includes individually optimised cell culture conditions and offers risk-adapted treatment, could be used for future personalised off-the-shelf therapies, for example, in myocardial infarction or stroke.

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The deadly business of an unregulated global stem cell industry

Cited by 38 publications

References 16 publications

Marketing Experimental Stem Cell Therapies in the UK: Biomedical Lifestyle Products and the Promise of Regenerative Medicine in the Digital Era

Marketing Experimental Stem Cell Therapies in the UK: Biomedical Lifestyle Products and the Promise of Regenerative Medicine in the Digital Era

Crowdfunding for Unproven Stem Cell–Based Interventions

Characterisation and In Vivo Safety of Canine Adipose-Derived Stem Cells

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