• bioethics
• health policy
• medical tourism
• stem cells

• Humans
• Cell- and Tissue-Based Therapy/methods
• Cell- and Tissue-Based Therapy/trends
• Stem Cell Transplantation/methods
• Evidence-Based Medicine

• EEC-1648035 National Science Foundation

• US Food and Drug Administration
• US federal regulations
• ethics
• online advertising
• patient safety
• perinatal stem cell products

• United States
• Direct-to-Consumer Advertising
• Pharmaceutical Preparations
• United States Food and Drug Administration
• Marketing
• Stem Cells

• US FDA
• US Food and Drug Administration
• US federal regulations
• direct-to-consumer online advertising
• regulatory claims
• state legislation
• stem cell interventions

• Direct-to-Consumer Advertising
• Exosomes
• Marketing
• Commerce
• Stem Cells

• Pew Charitable Trusts

• decision-making
• donation
• saudi arabia
• stem cell
• transplantation

• biomaterials
• bioprinting
• bioreactors
• legal/regulatory
• regeneration
• regulation
• repair
• stem cells
• tissue engineering

• Tissue Engineering/methods
• Bioprinting/methods
• Printing, Three-Dimensional
• Regenerative Medicine/methods
• Cell- and Tissue-Based Therapy
• Tissue Scaffolds

• education
• healthcare
• next generation
• pipeline
• regenerative medicine
• training
• translation
• undergraduate

• Humans
• Musculoskeletal Diseases
• Regenerative Medicine
• Societies, Medical
• Sports Medicine
• United States

• environmental health, ethics
• medical tourism
• regenerative medicine
• stem cell
• travel health

• Attitude of Health Personnel
• Cross-Sectional Studies
• Female
• Health Knowledge, Attitudes, Practice
• Humans
• Jordan
• Male
• Physicians
• Reproducibility of Results
• Stem Cells
• Surveys and Questionnaires

• Cell-based therapies
• epicondylitis
• msc
• rotator cuff pathology
• sports injuries
• tenocytes

Heart failure continues to be one of the leading causes of morbidity and mortality worldwide. Myocardial infarction is the primary causative agent of chronic heart failure resulting in cardiomyocyte necrosis and the subsequent formation of fibrotic scar tissue. Current pharmacological and non-pharmacological therapies focus on managing symptoms of heart failure yet remain unable to reverse the underlying pathology. Heart transplantation usually cannot be relied on, as there is a major discrepancy between the availability of donors and recipients. As a result, heart failure carries a poor prognosis and high mortality rate. As the heart lacks significant endogenous regeneration potential, novel therapeutic approaches have incorporated the use of stem cells as a vehicle to treat heart failure as they possess the ability to self-renew and differentiate into multiple cell lineages and tissues. This review will discuss past, present, and future clinical trials, factors that influence stem cell therapy outcomes as well as ethical and safety considerations. Preclinical and clinical studies have shown a wide spectrum of outcomes when applying stem cells to improve cardiac function. This may reflect the infancy of clinical trials and the limited knowledge on the optimal cell type, dosing, route of administration, patient parameters and other important variables that contribute to successful stem cell therapy. Nonetheless, the field of stem cell therapeutics continues to advance at an unprecedented pace. We remain cautiously optimistic that stem cells will play a role in heart failure management in years to come.

• Stem cells
• Heart failure
• Myocardial infarction
• Regeneration
• Remodeling
• Ethical issues

• cell therapy regulation
• cell-based treatments
• engraftment
• lung stem/progenitor cells
• stromal cells

It is imperative that researchers studying medical tourism connect their work with policy, so that its real-world challenges can be better understood, and more effectively addressed. This article gauges the scope and evolution of policy thinking in medical tourism research through a bibliometric review of published academic literature, to establish the extent to which researchers apply public policy theories and frameworks in their investigation of medical tourism, or consider the policy imperatives of their work.

A Boolean search of the Web of Science (WoS) Core Collection was performed to identify policy-related publications on medical tourism. We analyzed the results using bibliometrics and a data visualization software called VOSviewer to identify patterns in knowledge production and underlying network linkages in policy research on the subject.

Our findings suggest that only a small proportion of medical tourism research explicitly addresses policy issues or applies policy paradigms in their study approach. Field-specialized journals serving practitioners publish less research as compared to interdisciplinary social and health policy journals. Moreover, there are significant geographical and disciplinary disparities in the policy-orientation of research, and a predilection towards select policy areas such as reproductive and transplant tourism to the neglect of more holistic governance and health system considerations.

This article is a call to action for greater engagement by policy scholars on medical tourism, and for health researchers to more explicitly consider how their research might contribute to the understanding and resolution of contemporary policy challenges of medical tourism. Failure to clearly and consistently make the policy connection is a lost opportunity for researchers to frame the public debate, and influence policy thinking on medical tourism.

• Bibliometric analysis
• Health tourism
• Healthcare tourism
• Medical tourism
• Policy research
• Policy thinking

• consultation service
• ethical
• evidence-based medicine
• information for patients
• patient education
• patient navigation
• regenerative medicine education
• responsible translation
• unproven stem cell therapies

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Child
• Child, Preschool
• Communication
• Evidence-Based Medicine
• Female
• Humans
• Infant
• Interviews as Topic
• Male
• Middle Aged
• Minnesota/epidemiology
• Osteoarthritis/epidemiology
• Osteoarthritis/therapy
• Patient Navigation/standards
• Patient Participation/statistics & numerical data
• Referral and Consultation/standards
• Regenerative Medicine
• Retrospective Studies
• Young Adult

• UL1 TR002377 NCATS NIH HHS

The promise of stem cell (SC) therapies to restore functions of damaged tissues and organs brings enormous hope to patients, their families, loved ones, and caregivers. However, limits may exist for which indications SC therapies might be useful, efficacious, and safe. Applications of innovative therapies within regulatory boundaries and within the framework of controlled clinical trials are the norm in the scientific and medical community; such a system minimizes patient risk by setting a clear and acceptable safety and efficacy profile for new therapeutics before marketing authorization. This careful clinical validation approach often takes time, which patients suffering from terminal or debilitating diseases do not have. Not validated, unproven stem cell interventions (SCI) that promise a working treatment or cure for severe diseases have therefore found their way into the patient community, and providers of such treatments often take advantage of the public's willingness to pay large amounts of money for the misguided hope of a reliable recovery from their illnesses. We conducted a review of scientific publications, clinical case reports, and mass media publications to assess the reported cases and safety incidents associated with unproven SCI. The review also analyzes the main factors that were identified as contributing to the emergence and global rise of the “stem cell tourism” phenomenon. stemcellstranslationalmedicine2018;1–10

• Adverse events
• Clinical trials
• Ethics
• Hype
• Mesenchymal stromal cells
• Regulations
• Risks
• Stem cell clinics
• Stem cell tourism
• Stem cells
• Unproven interventions

• learning health system
• regenerative medicine
• stem cells

Direct to consumer offerings of unproven stem cell interventions (SCIs) is a pressing scientific and policy issue. According to media reports, providers of SCIs have emerged in Canada. This study provides the first systematic scan of Canadian providers and associated trends and claims.

The study sample consisted of 15 websites retrieved from a Google™ keyword search. The websites were assessed by a rater using a peer-reviewed coding frame that queried treatment location, stem cell offerings, treatment claims, supporting evidence, and legal and regulatory compliance. A second rater reviewed a subset of the websites for purposes of inter-rater reliability. Disagreements between raters were resolved by consensus. Data collected by the raters was analyzed in SPSS.

Physicians are the dominant treatment providers in Canada. Providers operate in urban and semi-urban areas in the most populous provinces. SCIs provided are mainly autologous adult stem cells for multiple conditions including musculoskeletal disorders, spinal cord injury (SCI) and diabetes. Efficacy and benefits of treatment are prominently and positively portrayed, while risks are not mentioned or portrayed as trivial. Regulatory concerns are not discussed.

The involvement of physicians in promoting and providing unproven and unapproved SCIs raises significant ethical, legal and regulatory concerns. Treatment claims and trends appear to contravene applicable professional standards, statutory obligations, and consumer protection laws. While the number of providers observed is still marginal, urgent and proactive regulatory response is needed to prevent proliferation of a potentially exploitative and harmful market for unproven SCIs in Canada.

The online version of this article (10.1186/s12910-018-0273-6) contains supplementary material, which is available to authorized users.

• Canada
• False advertising
• Physicians
• Stem cell
• Stem cell interventions (SCIs)
• Stem cell tourism
• Stem cell treatment
• Unproven treatments

• ethics
• regenerative medicine
• regulation
• research translation
• stem cells

• Bioethics
• Health Services Accessibility
• Humans
• Internationality
• Marketing of Health Services
• Medical Tourism
• Patient Rights
• Regenerative Medicine/ethics
• Stem Cell Transplantation/ethics
• Translational Research, Biomedical/ethics

• Wellcome Trust
• 204403/Z/16 Wellcome Trust

• Cooperative Behavior
• Government Regulation
• Health Policy/legislation & jurisprudence
• Humans
• Patient Safety/legislation & jurisprudence
• Policy Making
• Risk Assessment
• Stakeholder Participation
• Stem Cell Transplantation/adverse effects
• Stem Cell Transplantation/legislation & jurisprudence

• Parkinson
• communication
• eHealth
• media
• treatment

Alzheimer’s disease (AD) is the most common form of dementia which typically manifests as loss of memory and cognitive functions. Currently, available treatments for AD provide only symptomatic improvement and the benefit is minimal. Stem cell therapy (SCT) has been considered a promising treatment option for AD. We investigated the caregiver’s perception about implementation of SCT in their AD patients, and determined the factors related to SCT.

A total of 100 caregivers, who cared for their AD patients, were interviewed at two hospitals. Structured open and closed questions about SCT for AD were asked by trained interviewers using the conventional in-person method. In addition, 60 dementia-related physicians were randomly interviewed via an e-mail questionnaire.

Of the 100 subjects, 61 caregivers replied that they wanted their AD patients to receive SCT. Approximately 50% of the caregivers expected high improvement in cognitive function, behavioral and psychological symptoms, and activities of daily living, and physical improvements among their AD patients. However, physicians had much lower expectations of improvements in the above parameters. Multi-variate analysis revealed that female gender [odds ratio (OR): 3.747, 95% confidence interval (CI): 1.425–9.851] and familiarity with stem cells (OR: 3.873, 95% CI: 1.290–11.622) were independently associated with caregivers’ desire that their AD patients should undergo SCT. The major source of information on SCT was television (76.7%), and the most reliable source of information on SCT was physicians (83.6%).

In this study, many caregivers of AD patients fantasized and overestimated the need for SCT in comparison with physicians’ expectation. Therefore, it is necessary for physicians to develop strategies for educating caregivers about the appropriate risks and benefits of SCT.

• Alzheimer’s disease
• caregiver
• stem cell therapy

Although the safety and effectiveness of stem cell therapies are yet to be proven, recent studies show that such therapies are being advertised with some questionable marketing techniques to effect positive portrayal of the therapies on the webpages of private-practice clinics to sell their therapies worldwide. In such context, those clinics communicate directly with consumers (patients and their family members) via the clinics’ websites. Meanwhile, the Health Science Council at the Ministry of Health, Labour, and Welfare (MHLW) in Japan has pointed out noncompliance of some local clinics with the provisions concerning medical advertising in the Medical Care Act in the past. However, locally little is known about the current status of those clinics including the quality of their webpage information disseminated.

To evaluate the quality of website information of private-practice clinics offering cell therapies in Japan.

Twenty-four websites with 77 treatments from the Google search were identified for evaluation. The following three exploratory analyses were performed: first in order to ascertain web-based portrayal of private-practice clinics offering cell therapies, a descriptive analysis was conducted using a coding frame; second we evaluated the quality of the target website information from the viewpoint of the level of consideration taken for patients and their family members, using 10 quality criteria (“the Minimum Standard”) from the e-Health Code of Ethics 2.0; third we counted and coded expressions that matched set categories for “name-dropping” and “personalized medicine” in the information posted on these websites.

Analysis on the treatments (N=77) revealed 126 indications (multiple response): the top three indications were “cancer,” “skin-rejuvenation/antiaging/anti–skin aging,” and “breast augmentation/buttock augmentation.” As for the portrayal of treatment risks and benefits, 78% (60/77) of treatments were mentioned with “benefits,” whereas 77% (59/77) of treatments were mentioned with “risks.” As for the source(s) cited for the discussions of treatment risks and benefits, no treatment quoted an expert’s opinion for the risks, whereas 7% (6/77) treatments quoted external sources for the benefits. As for the results with e-Health Code of Ethics 2.0, not a single clinic fulfilled all the 10 criteria; 63% (15/24) of the clinics was found exercising “name-dropping,” and 21% (5/24) of the clinics mentioned expressions related to “personalized medicine” on their websites.

Our website content analyses confirmed the following: (1) the clinics mentioned the risks or benefits of the treatments with hardly any scientific citations, (2) the way the website information was disseminated was inappropriate for patients and their families, and (3) many websites seemed to be using marketing techniques in order to draw patients’ interests or attentions. It is important that more similar studies are undertaken globally to enable an orchestrated regulatory approach toward private-practice clinics.

• descriptive analysis
• direct-to-consumer
• health information
• medical tourism
• misrepresentation
• online marketing
• regenerative medicine
• regulations
• stem cell
• web survey

• commercialization
• pressure to commercialize
• applied research
• knowledge translation
• risks versus benefits
• science hype
• ethics
• science policy
• university research
• science funding

• Financing, Government/ethics
• Humans
• Policy Making
• Public Opinion
• Research Personnel/ethics
• Research Support as Topic/ethics
• Risk Assessment
• Technology Transfer
• Universities/economics
• Universities/ethics
• Universities/organization & administration

• Canadian Institutes of Health Research

Cell therapies are an emerging form of healthcare that offer significant potential to improve the practice of medicine and provide benefits to patients who currently have limited or no treatment options. Ideally, these innovative therapies can complement existing small molecule, biologic and device approaches, forming a so-called fourth pillar of medicine and allowing clinicians to identify the best treatment approach for each patient. Despite this potential, cell therapies are substantially more complex than small molecule or biologic interventions. This complexity poses challenges for scientists and firms developing cell therapies and regulators seeking to oversee this growing area of medicine.

In this project, we retrospectively examined the development of seven cell therapies – including three autologous interventions and four allogeneic interventions – with the aim of identifying common challenges hindering attempts to bring new cell therapies to market. We complemented this analysis with a series of qualitative interviews with experts in various aspects of cell therapy. Through our analysis, which included review of extant literature collected from company documents, newspapers, journals, analyst reports and similar sources, and analysis of the qualitative interviews, we identified several common challenges that cell therapy firms must address in both the pre- and post-market stages. Key pre-market challenges included identifying and maintaining stable funding to see firms through lengthy developmental timelines and uncertain regulatory processes. These challenges are not unique to cell therapies, of course, but the novelty of cell-based interventions complicates these efforts compared to small molecule or biologic approaches. The atypical nature of cell therapies also led to post-market difficulties, including challenges navigating the reimbursement process and convincing providers to change their treatment approaches. In addition, scaling up production, distributing cell therapies and managing the costs of production were challenges that started pre-market and continued into the post-market phase.

Our analysis highlights several interrelated challenges hindering the development of cell therapies. Identifying strategies to address these challenges may accelerate the development and increase the impact of novel cell therapies.

• Advertising
• Age Factors
• Cell Extracts/adverse effects
• Cell Extracts/therapeutic use
• Consumer Health Information
• Cosmetic Techniques/adverse effects
• Evidence-Based Medicine
• Humans
• Internet
• Language
• Marketing of Health Services
• Public Opinion
• Rejuvenation
• Risk Assessment
• Risk Factors
• Skin Aging
• Stem Cells

• Bioethics
• Biomedical innovation
• Governance
• Health consumers
• Hegemony
• Market
• Political economy
• Stem cells

An increasing number of private clinics in Australia are marketing and providing autologous stem cell therapies to patients. Although advocates point to the importance of medical innovation and the primacy of patient choice, these arguments are unconvincing. First, it is a stark truth that these clinics are flourishing while the efficacy and safety of autologous stem cell therapies, outside of established indications for hematopioetic stem cell transplantation, are yet to be shown. Second, few of these therapies are offered within clinical trials. Third, patients with chronic and debilitating illnesses, who are often the ones who take up these therapies, incur significant financial burdens in the expectation of benefiting from these treatments. Finally, the provision of these stem cell therapies does not follow the established pathways for legitimate medical advancement. We argue that greater regulatory oversight and professional action are necessary to protect vulnerable patients and that at this time the provision of unproven stem cell therapies outside of clinical trials is unethical.

• Animals
• Australia
• Autografts
• Cell- and Tissue-Based Therapy
• Humans
• Stem Cell Transplantation/economics
• Stem Cell Transplantation/ethics
• Stem Cell Transplantation/legislation & jurisprudence
• Stem Cells/cytology
• Treatment Outcome

• global healthcare market
• health consumer
• medical innovation
• regulation
• scientific innovation
• stem cell therapy

The pursuit of unproven stem cell-based interventions (“stem cell tourism”) is an emerging issue that raises various concerns. Physicians play different roles in this market, many of which engage their legal, ethical and professional obligations. In Canada, physicians are members of a self-regulated profession and their professional regulatory bodies are responsible for regulating the practice of medicine and protecting the public interest. They also provide policy guidance to their members and discipline members for unprofessional conduct.

We conducted semi-structured telephone interviews with representatives from six different provincial Colleges of Physicians and Surgeons in Canada to discuss their experiences and perspectives regarding stem cell tourism. Our focus was on exploring how different types of physician involvement in this market would be viewed by physicians’ professional regulatory bodies in Canada.

When considering physicians’ professional obligations, participants drew analogies between stem cell tourism and other areas of medical tourism as well as with some aspects of complementary alternative medicine where existing policies, codes of ethics and regulations provide some guidance. Canadian physicians are required to act in the best interests of their patients, respect patient autonomy, avoid conflicts of interest and pursue evidence-based practice in accordance with accepted standards of care. Physicians who provide unproven treatments falling outside the standard of care, not in the context of an approved research protocol, could be subject to professional discipline. Other types of problematic conduct include referrals involving financial conflict of interest and failure to provide urgent medically necessary care. Areas of ambiguity include physicians’ obligations when asked for information and advice about seeking unproven medical treatments, in terms of providing non-urgent follow-up care, and when asked to support efforts to go abroad by providing tests or procedures in advance that would not otherwise be medically indicated.

Specific policy guidance regarding the identified areas of tension or ambiguity may prove helpful for physicians struggling with these issues. Further consideration of the complex interplay of factors at issue in how physicians may (should) respond to patient demands related to unproven medical interventions while meeting their professional, legal and ethical obligations, is warranted.