Global Distribution of Businesses Marketing Stem Cell-Based Interventions

Berger, Israel; Ahmad, Amina; Bansal, Akhil; Kapoor, Tanvir; Sipp, Douglas; Rasko, John E.J.

doi:10.1016/j.stem.2016.07.015

Cited by 136 publications

(78 citation statements)

References 11 publications

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“…The growth of the industry engaged in direct-to-consumer marketing of unproven stem cell interventions online has become impossible to ignore 1,2 . Effective measures for regulating this sector both nationally and internationally are urgently needed.…”

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confidence: 99%

“…Such practices first emerged in the peripheries of international biomedical research and development 4 , but providers have been making inroads in some leading global markets, including Japan 5 , Australia 2,6 , and the United States 1,7 . Public warnings by scientific and medical groups 8,9 , government organizations 10 , and the media 11 Efforts to ensure that stem cell-based interventions rest on a foundation of scientific evidence have not all been in vain.…”

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confidence: 99%

“…In this Perspective, we draw on the mounting body of literature describing the growth and characteristics of direct-to-consumer marketing of stem cell-based therapies 1,2,18,19 to highlight a number of key features and challenges for broad-based efforts to regulate this industry. We also examine how past successes in countering the premature commercialization of stem cell-based therapies in medicine can inform coordinated responses to this phenomenon nationally and internationally.…”

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confidence: 99%

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Marketing of unproven stem cell–based interventions: A call to action

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Marketing of unproven stem cell–based interventions: A call to action

et al. 2017

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“…Providers offer to treat a range of diseases with stem cell interventions creating a global, direct-to-consumer market. While originally unproven stem cell interventions were thought to be offered in countries with lax regulatory standards [104], these interventions are beginning to be offered in highly regulated countries most notably the USA [105][106][107]. Educating scientists about the features of the stem cell tourism industry and strategies to mitigate SCR have been met with much excitement and enthusiasm by scientists [108][109][110][111][112][113].…”

Section: Teaching Stem Cell Ethics and Policymentioning

confidence: 99%

A Primer on Ethics Education for Stem Cell and Biomedical Scientists

et al. 2016

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Stem cell research is an exciting field with clinical potential and has been rapidly moving towards the goal of translating research into therapeutics. Like all scientific fields, there are many ethical, legal, and social issues (ELSI) associated with stem cell research and stem cell scientists, especially trainees, should be aware of them. In this paper, we describe how course directors at academic institutions can develop training on ELSI of stem cell research for scientists. We describe how to perform a needs assessment and planning to develop pedagogical tools. We cover elements of course design, content and venue, and course evaluation. Lastly, we broadly discuss course topics including the responsible conduct of research, ethics of research involving animals and humans, and stem cell ethics and policy. This paper is meant to be a practical guide for course directors interested in developing ELSI pedagogy for stem cell scientists.

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“…Private hospitals' business models from companies such as the now closed XCell Center in Germany [6] are mobile and hundreds of thousands of patients have bought such treatments, especially in Asia and in certain states in the USA [7][8][9][10]. The inevitable limitation of national or, in the case of Europe, transnational laws and regulations has been discussed widely in the literature on life science governance and SC research [11,12]. International professional associations occasionally take on the role of setting global standards, in this case the International Society for SC Research (ISSCR), which issued and re-issued guidelines for translation in 2008 and 2016 [13,14].…”

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Can Harmonized Regulation Overcome Intra-European Differences? Insights From a European Phase III Stem Cell Trial

Hauskeller

2017

Regen. Med.

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Harmonized regulation of research with human stem cells in Europe has shaped innovation in regenerative medicine. Findings from a Phase III academic clinical trial of an autologous cell procedure illustrate the obstacles that a multinational trial faces. A typology of the obstacles encountered, may help other teams embarking upon trials. The findings throw light on the situation of clinician-scientists in clinical innovation, as the expertise to run scientific trials is very complex. The innovation route of clinical translation takes insufficient account of the interdependencies between multiple social and cultural factors from outside the laboratory and the clinic. For ethical reasons, however, academic and business routes to stem cell treatments ought to be enabled by the regulators. Suggestions arise, how academics can prepare for trials, that academic research needs better institutional support and that new models of medical innovation may need to be developed for regenerative medicine. The landscape of regulations applying to innovations and medicine, and especially with human cells and tissues is chequered and shapes the socio-political environments in which regenerative medicine (RM) proceeds. Europe has very strict governance regimes in place that not only prevents rogue marketing of cell treatments, but also adds a high logistical and cost burden to the development of future therapies. Progress in approved clinical treatments is slow and pathways toward them are sought that solve the conundrum of pressing consumer demand and patient need, the problems arising from existing forms of regulatory oversight and the long time and high financial stakes involved in bringing new treatments into the clinic via the staggered model of the scientific clinical trial (CT). Medical translation from the laboratory bench to the bedside has become increasingly fraught with problems while it has become imperative for science to demonstrate its applicability [1][2][3].Salter, Zhou and Datta [4,5] discuss four innovation models for stem cell (SC) therapies. Model I is called "Scientific SC Innovation." This model follows the multistep process from basic research to clinical application in the established well-defined stages of the CT. They then discuss three other models (II, III and IV) that bridge the gulf between the traditional CT and patient-based or exemption-based uses of new treatments. Models II-IV make use of different ways of collecting data about the effects of experimental treatments, processes of scaling up from a physician or hospital exemption that are not formal CTs and tensions between the professional ethos of medicine and the technical approach to standardize that characterizes most regulations. For these models, they use the umbrella term "Medical SC Innovation." Models II, III and IV follow a wider set of prerogatives than the scientific model. They are often build on patients' self-reported health improvements and respond to the individual patient's needs or to the patient-consumers, who apply -and of...

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Global Distribution of Businesses Marketing Stem Cell-Based Interventions

Cited by 136 publications

References 11 publications

Marketing of unproven stem cell–based interventions: A call to action

Marketing of unproven stem cell–based interventions: A call to action

A Primer on Ethics Education for Stem Cell and Biomedical Scientists

Can Harmonized Regulation Overcome Intra-European Differences? Insights From a European Phase III Stem Cell Trial

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