Regulation of Stem Cell Therapy Travel

Cohen, I. Glenn; Simana, Shelly

doi:10.1007/s40778-018-0134-8

Cited by 7 publications

(7 citation statements)

References 38 publications

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“…While some countries have implemented regulations to curb stem cell tourism, many have inadvertently created loopholes whereby the regulations leave room for varied interpretation. 42 These clinics may then exploit these loopholes and offer unproven and risky treatments directly to patients. 42 In the USA, stem cell products are regulated by the Food and Drug Administration (FDA).…”

Section: Regulation Of Stem Cell Therapiesmentioning

confidence: 99%

“… 42 These clinics may then exploit these loopholes and offer unproven and risky treatments directly to patients. 42 In the USA, stem cell products are regulated by the Food and Drug Administration (FDA). In order to circumvent the rigorous regulatory approval process mandated by the FDA, many clinics have classified their stem cell therapies as human cellular and tissue-based products (HCT/P) rather than as biological drugs, 42 because HCT/Ps that are minimally manipulated and intended for homologous use are not subject to FDA regulations.…”

Section: Regulation Of Stem Cell Therapiesmentioning

confidence: 99%

“…Another legislative challenge is the lack of harmonised regulatory schemes across the world. 42 The legal divergences between countries in relation to codes of conduct, practice or ethics, as well as the enforcement patterns and bounds of a disciplinary authority, enable clinics to evade regulatory oversight. 10 The concern is that these jurisdictional variations create a platform by which clinics can seek out the most lenient regulatory environment.…”

Section: Regulation Of Stem Cell Therapiesmentioning

confidence: 99%

“…While acknowledging the differences in legal frameworks across nations, professional guidelines, such as those published by the ISSCR, should be formalised into international governmental regulations. 42 A global accreditation system operated by the WHO or Joint Commission International should be established, 57 whereby review boards can examine the quality of the information provided by clinics. 42 National authorities should enforce penalties against clinics making false claims.…”

Section: Future Directions and Research Prioritiesmentioning

confidence: 99%

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International stem cell tourism: a critical literature review and evidence-based recommendations

Lyons

Salgaonkar

Flaherty

2021

International Health

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Stem cell tourism is an emerging area of medical tourism activity. Frustrated by the slow translation of stem cell research into clinical practice, patients with debilitating conditions often seek therapeutic options that are not appropriately regulated. This review summarises recent developments in the field of stem cell tourism and provides clinicians with the information necessary to provide basic pretravel health advice to stem cell tourists. PubMed and Scopus databases were consulted for relevant publications, using combinations of the terms ‘stem cell’, ‘tourism’, ‘regenerative medicine’, ‘international’, ‘travel medicine’ and ‘environmental health’. The leading countries in the international stem cell tourism market are the USA, China, India, Thailand and Mexico. As the majority of clinics offering stem cell therapies are based in low- and-middle-income countries, stem cell tourists place themselves at risk of receiving an unproven treatment, coupled with the risk of travel-related illnesses. These clinics do not generally provide even basic travel health information on their websites. In addition to often being ineffective, stem cell therapies are associated with complications such as infection, rejection and tumorigenesis. Physicians, researchers, regulatory bodies, advocacy groups and medical educators are encouraged to work together to improve patient and physician education and address current legislative deficiencies.

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Section: Regulation Of Stem Cell Therapiesmentioning

confidence: 99%

Section: Regulation Of Stem Cell Therapiesmentioning

confidence: 99%

Section: Regulation Of Stem Cell Therapiesmentioning

confidence: 99%

Section: Future Directions and Research Prioritiesmentioning

confidence: 99%

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International stem cell tourism: a critical literature review and evidence-based recommendations

Lyons

Salgaonkar

Flaherty

2021

International Health

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“…But in adherence to regulatory agencies' laws, and revision of policies means some are located in or have relocated to less advanced developing countries with less well defined regulation. This means that some patient may need to travel outside their country for receiving unproven SCI giving rise to the concept of "stem cell tourism" (Ryan et al, 2010;Cohen & Simana, 2018;Julian et al, 2018).…”

Section: The Growing Phenomenon Of Stem Cell Tourism Financial Explomentioning

confidence: 99%

An Overview of the Journey of Stem Cell Based Interventions from Bench to Bedside and the Growing Challenge of Unproven Interventions

Ghori¹,

Wahid²

2018

RHS

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Background: Current researches on Stem Cell Interventions (SCI) are mostly at various stages of clinical translation, and not ripe for immediate marketing. However, there is a global rise in patients opting for unproven SCI from dubious stem cell clinics.Objectives: To describes the usual stages of SCI’s clinical translation, factors fuelling the increase in unproven SCI and possible strategies for tackling the situation that have been mentioned in research articles and patient information sources. Conclusion: Stem cell tourism is on the rise. Direct to customer marketing of SCI through websites and social media using emotional narratives, patient testimonials and false claims of benefits, and unrealistically positive portrayal on social media are contributing factors. The situation may be addressed by treating stem cells as medical innovation and speeding up their clinical translation using modifications like expedited, conditional marketing approval. Medical societies can generate meta-analyses and updates for keeping clinicians informed about the latest therapies so they can guide patients. These along with organisations like ALSuntangled, can generate patient information booklets to help patients make informed decisions. Also, Patient Information Campaigns on social media and media’s coverage of increasing SCI related lawsuits can possibly help raise public awareness about unproven SCI.

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Medical Crowdfunding for Unproven Medical Treatments: Should Gofundme Become a Gatekeeper?

Snyder¹,

Cohen²

2019

Hastings Center Report

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Medical crowdfunding has raised many ethical concerns, among them that it may undermine privacy, widen health inequities, and commodify health care. One motivation for medical crowdfunding has received particular attention among ethicists. Recent studies have shown that many individuals are using crowdfunding to finance access to scientifically unsupported medical treatments. Recently, GoFundMe prohibited campaigns for antivaccination groups on the grounds that they “promote misinformation about vaccines” and for treatment at a German clinic offering unproven cancer treatments due to “the need to make sure people are equipped to make well‐informed decisions.” GoFundMe has not taken any additional actions to regulate the much larger presence of campaigns seeking to fund unproven medical interventions on the platform. In this article, we make the ethical case for intervention by GoFundMe and other crowdfunding platforms.

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Regulation of Stem Cell Therapy Travel

Cited by 7 publications

References 38 publications

International stem cell tourism: a critical literature review and evidence-based recommendations

International stem cell tourism: a critical literature review and evidence-based recommendations

An Overview of the Journey of Stem Cell Based Interventions from Bench to Bedside and the Growing Challenge of Unproven Interventions

Medical Crowdfunding for Unproven Medical Treatments: Should Gofundme Become a Gatekeeper?

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