92 results on '"Munsie, M"'
Search Results
2. Ethical issues and public communication in the development of cell-based treatments for COVID-19: Lessons from the pandemic
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Turner, L, Munsie, M, Levine, AD, Ikonomou, L, Turner, L, Munsie, M, Levine, AD, and Ikonomou, L
- Abstract
The significant morbidity and mortality of coronavirus disease 19 (COVID-19) prompted a global race to develop new therapies. These include interventions using cell- or cell-derived products, several of which are being tested in well-designed, properly controlled clinical trials. Yet, the search for cell-based COVID-19 treatments has also been fraught with hyperbolic claims; flouting of crucial regulatory, scientific, and ethical norms; and distorted communication of research findings. In this paper, we critically examine ethical issues and public communication challenges related to the development of cell-based therapeutics for COVID-19. Drawing on the lessons learned from this ongoing process, we argue against the rushed development of cell-based interventions. We conclude by outlining ways to improve the ethical conduct of cell-based clinical investigations and public communication of therapeutic claims.
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- 2021
3. ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update
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Lovell-Badge, R, Anthony, E, Barker, RA, Bubela, T, Brivanlou, AH, Carpenter, M, Charo, RA, Clark, A, Clayton, E, Cong, Y, Daley, GQ, Fu, J, Fujita, M, Greenfield, A, Goldman, SA, Hill, L, Hyun, I, Isasi, R, Kahn, J, Kato, K, Kim, J-S, Kimmelman, J, Knoblich, JA, Mathews, D, Montserrat, N, Mosher, J, Munsie, M, Nakauchi, H, Naldini, L, Naughton, G, Niakan, K, Ogbogu, U, Pedersen, R, Rivron, N, Rooke, H, Rossant, J, Round, J, Saitou, M, Sipp, D, Steffann, J, Sugarman, J, Surani, A, Takahashi, J, Tang, F, Turner, L, Zettler, PJ, Zhai, X, Lovell-Badge, R, Anthony, E, Barker, RA, Bubela, T, Brivanlou, AH, Carpenter, M, Charo, RA, Clark, A, Clayton, E, Cong, Y, Daley, GQ, Fu, J, Fujita, M, Greenfield, A, Goldman, SA, Hill, L, Hyun, I, Isasi, R, Kahn, J, Kato, K, Kim, J-S, Kimmelman, J, Knoblich, JA, Mathews, D, Montserrat, N, Mosher, J, Munsie, M, Nakauchi, H, Naldini, L, Naughton, G, Niakan, K, Ogbogu, U, Pedersen, R, Rivron, N, Rooke, H, Rossant, J, Round, J, Saitou, M, Sipp, D, Steffann, J, Sugarman, J, Surani, A, Takahashi, J, Tang, F, Turner, L, Zettler, PJ, and Zhai, X
- Abstract
The International Society for Stem Cell Research has updated its Guidelines for Stem Cell Research and Clinical Translation in order to address advances in stem cell science and other relevant fields, together with the associated ethical, social, and policy issues that have arisen since the last update in 2016. While growing to encompass the evolving science, clinical applications of stem cells, and the increasingly complex implications of stem cell research for society, the basic principles underlying the Guidelines remain unchanged, and they will continue to serve as the standard for the field and as a resource for scientists, regulators, funders, physicians, and members of the public, including patients. A summary of the key updates and issues is presented here.
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- 2021
4. The direct-to-consumer market for stem cell-based interventions in Australia: Exploring the experiences of patients Special Report
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Waldby, C, Hendl, T, Kerridge, I, Lipworth, W, Lysaght, T, Munsie, M, and Stewart, C
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ethical ,2201 Applied Ethics ,marketing ,legal/regulatory ,adult stem cells ,advertising ,direct-to-consumer ,health care economics and organizations ,policy ,1117 Public Health and Health Services - Abstract
The prevalence of businesses selling autologous stem cell-based interventions (ASCBI) to patients in Australia has raised serious concerns about how weaknesses in regulation have enabled the emergence of an industry that engages in aggressive marketing of unproven treatments to patients. Little is known about how patients experience this marketing and their subsequent interactions with practitioners. This paper reports results from fifteen semi-structured interviews with patients and carers, and also draws upon discussion conducted with patients, carers and family members (22 participants) in a workshop setting. We explore how Australian patients and carers understand and experience these interventions, and how their presumptions about the ethics of medical practice, and the regulatory environment in Australia have conditioned their preparedness to undergo unproven treatments
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- 2020
5. Toward Guidelines for Research on Human Embryo Models Formed from Stem Cells
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Hyun, I, Munsie, M, Pera, MF, Rivron, NC, Rossant, J, Hyun, I, Munsie, M, Pera, MF, Rivron, NC, and Rossant, J
- Abstract
Over the past few years, a number of research groups have reported striking progress on the generation of in vitro models from mouse and human stem cells that replicate aspects of early embryonic development. Not only do these models reproduce some key cell fate decisions but, especially in the mouse system, they also mimic the spatiotemporal arrangements of embryonic and extraembryonic tissues that are required for developmental patterning and implantation in the uterus. If such models could be developed for the early human embryo, they would have great potential benefits for understanding early human development, for biomedical science, and for reducing the use of animals and human embryos in research. However, guidelines for the ethical conduct of this line of work are at present not well defined. In this Forum article, we discuss some key aspects of this emerging area of research and provide some recommendations for its ethical oversight.
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- 2020
6. Gaining Clarity of the Ethicial Issues of a Possible COVID-19 Vaccine
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Munsie, M, Gyngell, C, Taylor-Sands, M, Munsie, M, Gyngell, C, and Taylor-Sands, M
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Given the implications for potential take-up of a COVID-19 vaccine, it's important to unpack religious as well as the general ethical concerns from using human cell lines.
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- 2020
7. The direct-to-consumer market for stem cell-based interventions in Australia: exploring the experiences of patients
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Waldby, C, Hendl, T, Kerridge, I, Lipworth, W, Lysaght, T, Munsie, M, Stewart, C, Waldby, C, Hendl, T, Kerridge, I, Lipworth, W, Lysaght, T, Munsie, M, and Stewart, C
- Abstract
The prevalence of businesses selling autologous stem cell-based interventions to patients in Australia has raised serious concerns about how weaknesses in regulation have enabled the emergence of an industry that engages in aggressive marketing of unproven treatments to patients. Little is known about how patients experience this marketing and their subsequent interactions with practitioners. This paper reports results from 15 semistructured interviews with patients and carers, and also draws upon discussion conducted with patients, carers and family members (22 participants) in a workshop setting. We explore how Australian patients and carers understand and experience these interventions, and how their presumptions about the ethics of medical practice, and the regulatory environment in Australia have conditioned their preparedness to undergo unproven treatments.
- Published
- 2020
8. Electrical and neurotransmitter activity of mature neurons derived from mouse embryonic stem cells by Sox-1 lineage selection and directed differentiation
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Lang, R. J., Haynes, J. M., Kelly, J., Johnson, J., Greenhalgh, J., OʼBrien, C., Mulholland, E. M., Baker, L., Munsie, M., and Pouton, C. W.
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- 2004
9. Selling stem cells in Australia: assessing the impact of new advertising standards on business practices
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Tanner, C.E., primary, Woodward-Kron, R., additional, Stewart, C., additional, and Munsie, M., additional
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- 2019
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10. Autologous stem cell-based interventions in Australia: exploring patient experience in light of regulatory exceptionalism
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Waldby, C., primary, Hendl, T., additional, Munsie, M., additional, Lysaght, T., additional, Lipworth, W., additional, Kerridge, I., additional, and Stewart, C., additional
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- 2019
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11. Navigating the cartographies of trust: how patients and carers establish the credibility of online treatment claims
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Petersen, A, Tanner, C, Munsie, M, Petersen, A, Tanner, C, and Munsie, M
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Digital media offer citizens novel ways of 'enacting' health and illness, and treatment and care. However, while digital media may so 'empower' citizens, those searching for credible information will be confronted with various, often-conflicting claims that may have 'disempowering' effects. This article uses Gieryn's concept of the 'cultural cartography' to explore the criteria that patients and carers employ in establishing the credibility of information on alleged treatments. Drawing on data from interviews with Australian patients and carers who have travelled or considered travelling abroad for unproven commercial stem cell treatments, the article examines how individuals assess rival sources of epistemic authority - science-based and non-science-based - as they search for credible information. As we argue, in a context where conventional treatment options are perceived to be limited or non-existent - which is likely to be the case with those suffering severe, life-limiting conditions - and the credibility of sources uncertain, matters of opinion and belief are prone to being interpreted as matters of fact, with potentially far-reaching implications for citizens' health. Revealing the mechanisms by which individuals ascribe credibility to health information, we conclude, has become crucial as digital media assume a growing role in health and healthcare and governments encourage citizens to become 'digitally literate'.
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- 2019
12. Finally, unproven stem cell clinic practices might be curtailed
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Munsie, M, Stewart, C, and Kerridge, I
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stem cell risks ,regulations ,Stem cell marketing ,stem cell treatments ,stem cell clinics - Abstract
In a welcomed move, the Therapeutic Goods Administration (TGA) has this week announced reforms will be introduced in 2018 to address long held concerns about the provision of unproven stem cell treatments to increasing numbers of Australian and international patients. Regulation of stem cell treatments being offered outside hospitals will be increased. It will acknowledge the risks of these treatments, and advertising of certain treatments will be prohibited. While more specific details are not yet available, it seems at last possible the most egregious practices of suburban stem cell clinics will be severely curtailed. Stem cell marketing Over the last six years, the number of private “stem cell” clinics operating across Australia has grown from a handful to more than 60. These clinics offer treatments for myriad conditions, from anti-ageing “facial rejuvenation” to treatment for osteoarthritis, lung diseases, infertility, motor neurone disease, dementia and multiple sclerosis. Advertising their services online and in social media, the clinics use claims of efficacy and expertise to lure patients. But they offer little, if any, scientific proof their treatments work, and charge patients exorbitant fees for their services.
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- 2017
13. Selling stem cells with tokens of legitimacy: An analysis of websites in Japan and Australia
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Lysaght, T., primary, Munsie, M., additional, Hendl, T., additional, Tan, L., additional, Kerridge, I., additional, and Stewart, C., additional
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- 2018
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14. The Deadly Business of an Unregulated Global Stem Cell Industry
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Lysaght, T, Lipworth, W, Hendl, T, Kerridge, I, Munsie, M, Waldby, C, and Stewart, C
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stem cell regulation ,autologous stem cell procedures ,autologous stem cell ,stem cell interventions - Abstract
In 2016, the Office of the State Coroner of New South Wales released its report into the death of an Australian woman, Sheila Drysdale, who had died from complications of an autologous stem cell procedure at a Sydney clinic. In this report, we argue that Mrs Drysdale's death was avoidable, and it was the result of a pernicious global problem of an industry exploiting regulatory systems to sell unproven and unjustified interventions with stem cells. Research for this paper was supported with the funding from an Australian Research Council Linkage Project Grant (LP150100739) and the National University of Singapore, Office of the Deputy President (Research and Technology)—Humanities and Social Sciences Research Fund (WBS: R-171-000-055-646).
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- 2017
15. The Stem Cell 'Sell'
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Munsie, M, Kerridge, I, Stewart, C, Hendl, T, Lipworth, W, Lysaght, T, and Waldby, C
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stem cell clinic ,stem cells ,evidence ,medical tourism ,stem cell tourism ,stem cell therapy ,ethics - Abstract
In recent years, a growing number of clinics in Australia and overseas have begun to offer therapies that claim to restore health by using stem cells to replace or repair the patient's faulty or missing cells. For those who have been told that conventional medicine has nothing more to offer, a visit to a stem cell clinic may appear to be worth the time, effort and expense that this entails. What’s on Offer? Stem cell tourism is a phrase used to encompass travel – usually overseas – for a wide range of therapies involving stem cells. These therapies may involve the use of the patient’s own (autologous) stem cells from fat or their bone marrow, or donated stem cells from cord blood, embryos and foetal tissue. Therapy might be administered by having the patient inhale the cells, or by injecting the cells under the skin, into a vein or joint, directly into the fluid around the spinal cord or into the patient’s brain. Such therapies have been touted as effective treatments for many conditions and illnesses including arthritis, spinal cord injury, motor neurone disease, multiple sclerosis, cerebral palsy, neurodegenerative conditions and autism. Often the same treatment is offered for conditions with vastly different underlying pathology. Unlike other forms of medical tourism – such as travel for IVF, cosmetic surgery, joint replacement or dentistry, which are based on access to well-established conventional therapies that are available more quickly and at a more affordable price than in the patient’s home country – stem cell tourism provides patients with access to “treatments” that are yet to be proven. These treatments are not based upon rigorous scientific evidence, have not been clearly demonstrated to offer any benefit, and are not recognised or reimbursed by local health systems. The reality, sadly, is very different. Most people are unlikely to benefit, losing precious time, money, hope and trust in the course of pursuing this new form of medical tourism.
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- 2016
16. The European General Data Protection Regulation: challenges and considerations for iPSC researchers and biobanks
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Morrison, M, Bell, J, George, C, Harmon, S, Munsie, M, Kaye, J, Morrison, M, Bell, J, George, C, Harmon, S, Munsie, M, and Kaye, J
- Abstract
Increasingly, human induced pluripotent stem cells (iPSC) and their associated genetic and clinical information are being used in a wide range of applications, with large biobanks being established to support and increase their scientific use. The new European General Data Protection Regulations, which comes into effect in 2018, will have implications for biobanks that generate, store and allow research access to iPSC. This paper describes some of the challenges that iPSC biobanks face and suggests some points for the development of appropriate governance structures to address these new requirements. These suggestions also have implications for iPSC research in general.
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- 2017
17. Trends and Challenges in Biobanking
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Freckelton, I, Petersen, K, Kaye, J, Bell, J, Prictor, M, Munsie, M, Freckelton, I, Petersen, K, Kaye, J, Bell, J, Prictor, M, and Munsie, M
- Abstract
The last twenty years have seen the emergence of the phenomena of biobanks, which are now regarded as essential research infrastructure in most countries around the world. However, the very nature of biobanks, as long-term repositories of sample and data that are used for many different research purposes continues to challenge many of the legal requirements for medical research, both in the UK and Australia. This chapter will provide an overview of biobanking and discuss some of the legal challenges that these activities raise by discussing and comparing the UK and Australian legal landscapes.
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- 2017
18. An Interactive Multimedia Approach to Improving Informed Consent for Induced Pluripotent Stem Cell Research.
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Munsie M., Fenwick E., Rees G., Wong R.C.B., Vickers J.C., Summers M.J., MacGregor C., Craig J.E., McCaughey T., Liang H.H., Chen C., Hewitt A.W., Pebay A., Munsie M., Fenwick E., Rees G., Wong R.C.B., Vickers J.C., Summers M.J., MacGregor C., Craig J.E., McCaughey T., Liang H.H., Chen C., Hewitt A.W., and Pebay A.
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- 2016
19. Blindspots and boundaries: Exploring the role and ethical responsibilities of facilitators of stem cell tourism
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Lundin, S, Krolokke, C, Muller, E, Peterson, M, MUNSIE, M, Martin, DE, Lundin, S, Krolokke, C, Muller, E, Peterson, M, MUNSIE, M, and Martin, DE
- Published
- 2016
20. Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines
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Daley, GQ, Hyun, I, Apperley, JF, Barker, RA, Benvenisty, N, Bredenoord, AL, Breuer, CK, Caulfield, T, Cedars, MI, Frey-Vasconcells, J, Heslop, HE, Jin, Y, Lee, RT, McCabe, C, Munsie, M, Murry, CE, Piantadosi, S, Rao, M, Rooke, HM, Sipp, D, Studer, L, Sugarman, J, Takahashi, M, Zimmerman, M, Kimmelman, J, Daley, GQ, Hyun, I, Apperley, JF, Barker, RA, Benvenisty, N, Bredenoord, AL, Breuer, CK, Caulfield, T, Cedars, MI, Frey-Vasconcells, J, Heslop, HE, Jin, Y, Lee, RT, McCabe, C, Munsie, M, Murry, CE, Piantadosi, S, Rao, M, Rooke, HM, Sipp, D, Studer, L, Sugarman, J, Takahashi, M, Zimmerman, M, and Kimmelman, J
- Abstract
The International Society for Stem Cell Research (ISSCR) presents its 2016 Guidelines for Stem Cell Research and Clinical Translation (ISSCR, 2016). The 2016 guidelines reflect the revision and extension of two past sets of guidelines (ISSCR, 2006; ISSCR, 2008) to address new and emerging areas of stem cell discovery and application and evolving ethical, social, and policy challenges. These guidelines provide an integrated set of principles and best practices to drive progress in basic, translational, and clinical research. The guidelines demand rigor, oversight, and transparency in all aspects of practice, providing confidence to practitioners and public alike that stem cell science can proceed efficiently and remain responsive to public and patient interests. Here, we highlight key elements and recommendations in the guidelines and summarize the recommendations and deliberations behind them.
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- 2016
21. 220 - Selling stem cells with tokens of legitimacy: An analysis of websites in Japan and Australia
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Lysaght, T., Munsie, M., Hendl, T., Tan, L., Kerridge, I., and Stewart, C.
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- 2018
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22. Tempering hope with realism. Induced pluripotent stem cells in regenerative medicine
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Fung, R, Kerridge, I, Skene, L, and Munsie, M
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human induced pluripotent stem (iPS) cells ,regenerative medicine ,iPS cell therapy ,human embryonic stem cells ,cell transplantation - Abstract
• Since their discovery in 2007, human induced pluripotent stem (iPS) cells have been widely championed as the future for regenerative medicine. • By differentiating iPS cells into specialised cells for transplantation, it may be possible to replace diseased cells and “cure” patients of various chronic degenerative conditions, including Parkinson’s disease. • Such putative iPS cell-based therapies would avoid the need to procure transplantable cells from (and in the process, destroy) human embryos, and could be administered to patients without immunosuppressive therapy. • In reality, however, the optimism surrounding iPS cell research has outpaced progress to date and likely emanates, in part, from the “moral panic” surrounding human embryo research. • At such an early stage of development, questions remain about whether iPS cells are strictly equivalent to human embryonic stem cells as a source of transplantable cells. The Heerey Committee considered this point in its recent review of the Commonwealth legislation governing embryo research and human cloning and its Report (tabled in federal Parliament in July 2011) recommended that embryonic stem cell research should continue in Australia. • In addition, there are many ethical issues which will need to be considered when enrolling vulnerable patients in trials of iPS cell therapy given the uncertain benefits and risks involved. • In the rush to embrace iPS cell therapy, there is a real risk that the public may overrate the benefits and expect imminent translation to the clinic.
- Published
- 2012
23. What if stem cells turn into embryos in a dish?
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Pera, M.F., Pera, M.F., de Wert, G., Dondorp, W., Lovell-Badge, R., Mummery, C.L., Munsie, M., Tam, P.P., Pera, M.F., Pera, M.F., de Wert, G., Dondorp, W., Lovell-Badge, R., Mummery, C.L., Munsie, M., and Tam, P.P.
- Abstract
Recent studies show that pluripotent stem cells can undergo self-organized development in vitro into structures that mimic the body plan of the post-implantation embryo. Modeling human embryogenesis in a dish opens up new possibilities for the study of early development and developmental disorders, but it may also raise substantial ethical concerns.
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- 2015
24. Managing the potential and pitfalls during clinical translation of emerging stem cell therapies
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Main, H, Munsie, M, O'Connor, MD, Main, H, Munsie, M, and O'Connor, MD
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We are moving into a new era of stem cell research where many possibilities for treatment of degenerative, chronic and/or fatal diseases and injuries are becoming primed for clinical trial. These reports have led millions of people worldwide to hope that regenerative medicine is about to revolutionise biomedicine: either through transplantation of cells grown in the laboratory, or by finding ways to stimulate a patient's intrinsic stem cells to repair diseased and damaged organs. While major contributions of stem cells to drug discovery, safety and efficacy testing, as well as modelling 'diseases in a dish' are also expected, it is the in vivo use of stem cells that has captured the general public's attention. However, public misconceptions of stem cell potential and applications can leave patients vulnerable to the influences of profit driven entities selling unproven treatments without solid scientific basis or appropriate clinical testing or follow up. This review provides a brief history of stem cell clinical translation together with an overview of the properties, potential, and current clinical application of various stem cell types. In doing so it presents a clearer picture of the inherent risks and opportunities associated with stem cell research translation, and thus offers a framework to help realise invested expectations more quickly, safely and effectively.
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- 2014
25. Therapeutic journeys: the hopeful travails of stem cell tourists
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Petersen, A., Seear, Kathryn, Munsie, M., Petersen, A., Seear, Kathryn, and Munsie, M.
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The recent growth of so-called stem cell tourism reflects the high optimism that currently surrounds stem cell science. Stem cell treatments for various conditions are increasingly advertised over the Internet as being available at hospitals and clinics around the world. However, most are clinically unproven. Despite numerous warnings from scientists about the dangers posed by such treatments, many individuals are evidently prepared to take the risk, sometimes on more than one occasion. This article explores the dynamics of hope that underpin stem cell tourism. Drawing on ideas from the sociology of hope, as applied to biomedicine, the article explores how hope is constructed and shapes actions in relation to stem cell treatments. Making reference to the findings from an Australian study of patients and carers who travelled overseas to receive stem cell treatments, it is argued that hope has an ambiguous significance in the context of deregulated health care. As we explain, this has implications for patients' and carers' treatment decisions and experiences. The findings are discussed in light of current responses to stem cell tourism.
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- 2014
26. Expression of stem cell factor in the postnatal rat testis.
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Loveland K.L., Schlatt S., Munsie M., DeKretser D.M., Loveland K.L., Schlatt S., Munsie M., and DeKretser D.M.
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The expression of stem cell factor (SCF) mRNA and protein was examined in the postnatal rat testis. Northern blot analysis of total RNA from 1-4 days postpartum (dpp) testes showed none or barely detectable levels of the ~6.5 kb SCF transcript. At 5 dpp, there was a striking elevation in this mRNA, a timing that coincides with the onset of spermatogonial proliferation. Immunohistochemical staining of testes showed that SCF protein was readily detected within Sertoli cells at 1-7 dpp and in the adult. Immunoreactive material was also detected within gonocytes and within Leydig cells at 1-7 dpp and in Leydig cells in the adult. Given the intense staining of Leydig cells by two different antibodies to SCF, the potential synthesis of SCF mRNA by these cells was investigated. Northern blot and reverse transcription/polymerase chain reaction analysis indicated that adult Leydig cells do not synthesize SCF mRNA, and Sertoli cells do. The significance of these findings is discussed in the context of germ cell-Sertoli cell interactions and Leydig cell function.
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- 2012
27. Unconventional practice, 'innovative' interventions and the national law
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Stewart, C., Kerridge, I., Waldby, C., Lipworth, W., Munsie, M., Lysaght, T., Rudge, C., Ghinea, N., Eckstein, L., Neilsen, J., Kaldor, J., and Dianne Nicol
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1801 Law ,unsatisfactory professional practice ,2201 Applied Ethics ,Health Personnel ,informed consent ,Australia ,Humans ,unconventional practice ,innovation ,professional misconduct ,1117 Public Health and Health Services - Abstract
This column explores a recent health profession disciplinary case which throws light on the problems of unconventional interventions by medical practitioners under the Health Practitioner Regulation National Law Act 2009 (Qld). The case involved “innovative” practices which were later found to have been scientifically unsupported, dangerous to patients and grounds for cancelling the health practitioner’s registration. The article looks at common features of these kinds of cases in Australia and then examines recent attempts by the Medical Board of Australia to draft policy guidance around the use of unconventional practice in medicine. The article concludes with a number of changes to improve the effectiveness of the proposed policy.
28. What is known about healthcare professional-patient communication when discussing stem cell therapies? A scoping review.
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Rees L, Friis T, Woodward-Kron R, and Munsie M
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- Humans, Health Personnel psychology, Physician-Patient Relations, Communication, Stem Cell Transplantation, Professional-Patient Relations
- Abstract
Objectives: When therapeutic options are limited, patients may invest hope in therapies proposed by healthcare professional, or those they find online. This review aims to explore how healthcare professional-patient communication is realised when discussing stem cell therapies., Method: Four electronic databases were systematically searched for relevant studies. Twenty-six studies met the inclusion criteria. Descriptive analyses and a thematic analysis guided by a functions of medical communication framework were performed on extracted data., Results: Most included studies addressed communication in contexts of conventional stem cell therapies, such as bone marrow transplants for blood cancers. Few studies investigated communication in contexts of experimental stem cell therapies yet to receive regulatory approval. Two themes were identified as informational and relational aspects of communication, and a third theme being a mismatch in orientations., Conclusions: Communication between healthcare professionals and patients about stem cell therapies is practised using a combination of communication approaches that do not always align with patients' needs, hopes or expectations., Practice Implications: The context of healthcare settings and health conditions are important when communicating about stem cell therapies. Acknowledging healthcare professionals' environmental and personal determinants can inform strategies to navigate complex discussions about stem cell therapies with patients., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)
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- 2025
- Full Text
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29. Effective regulatory responses to predatory stem cell markets in Australia and Canada.
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Ikonomou L, Munsie M, Power C, Sipp D, Turner L, and Rasko JEJ
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- Australia, Canada, Humans, Direct-to-Consumer Advertising legislation & jurisprudence, Stem Cells cytology
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The rapid proliferation of businesses engaged in direct-to-consumer advertising of unproven stem cell interventions has raised troubling questions about whether government bodies can regulate this health market effectively. Recent developments in Australia and Canada suggest that such fears are unfounded and that targeted regulatory action can have meaningful effects., Competing Interests: Declaration of interests J.E.J.R. has advisory roles in the Gene Technology Technical Advisory Committee, Office of the Gene Technology Regulator, Australian Government; in the Human Research Ethics Committee, Genea; and as a member of the Data Safety Monitoring Board for a Fanconi anemia trial. He has shareholdings with Rarecyte and Woke and receives grant/research support from the NHMRC (GNT1177305), the NSWCC, the CINSW, the MRFF, Therapeutic Innovation Australia, and philanthropic foundations. J.E.J.R. receives supply of material (MTA), consultancy, or honoraria from Rarecyte; Novartis; bluebird bio; Spark Therapeutics, Inc.; Cynata Therapeutics; Pfizer; and CRISPRTx. He is a member of the board of directors or an advisory committee for these bodies: AAVec Bio, cofounder, and Kennerton Capital, non-executive director. He is employed by the Sydney Local Health District at Royal Prince Alfred Hospital. L.T. served as a compensated expert witness for the US government in a criminal case and as a pro bono expert witness in a class action lawsuit. He is a member of the International Society for Cell & Gene Therapy and its Ethics of Cell and Gene Therapy Committee. He is also a member of the International Society for Stem Cell Research and its Ethics Committee. L.T.’s research program has received funding from the Pew Charitable Trusts and the University of California, Irvine. L.I. served as a pro bono expert witness in a class action lawsuit. He is a member of the International Society for Cell & Gene Therapy and its Ethics of Cell and Gene Therapy Committee. He is also a member of the International Society for Stem Cell Research. L.I.’s research program has received funding from the US National Institutes of Health and the University at Buffalo. M.M. serves on the board of the International Society for Stem Cell Research and is a member of its Ethics and Public Policy Committees. She is the President of the Australasian Society for Stem Cell Research and a board member of the National Stem Cell Foundation of Australia. M.M.’s research program receives funding from reNEW, the Novo Nordisk Foundation Center for Stem Cell Medicine (NNF21CC0073729), and the Australian Government Medical Research Future Fund (APP2007623)., (Copyright © 2024 Elsevier Inc. All rights reserved.)
- Published
- 2024
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30. Towards stem cell therapies for hearing loss: awareness and perspectives of Australian audiologists and their patients.
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Iem D, Carney G, Munsie M, and Nayagam BA
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- Humans, Australia, Adult, Male, Female, Middle Aged, Surveys and Questionnaires, Awareness, Health Knowledge, Attitudes, Practice, Hearing Loss therapy, Stem Cell Transplantation, Audiologists
- Abstract
Aim: Over the last two decades, numerous experimental studies have examined the feasibility of delivering stem cells into the cochlea to restore hearing. While these studies have spawned new cell therapy companies, there is little information on what patients understand or expect from these emerging therapies. Methods: This study sought to understand the awareness and perspectives of Australian audiologists and their adult patients toward stem cell therapies for treating hearing loss. Results: An anonymous survey indicated 91% of patients and 39% of audiologists were unaware of these therapies being developed. Thirty percent of audiologists reported being asked about stem cell therapies for hearing loss, but 70% were not confident answering patient queries about this and were unsure where to gather information. Primary concerns reported by patients were cost (45%) and safety of treatment (42%). Interestingly, 58% of patients were unsure of how this therapy would improve their hearing, yet 25% of these patients expected that their hearing would return to normal. Conclusion: There was strong support for development of educational materials for both patient and clinician. The increasingly important role of audiologists in providing patient counselling was reflected in overwhelming support (from both patient and clinician) for audiologists providing such information.
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- 2024
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31. Author Correction: 'Ceci n'est pas un embryon?' The ethics of human embryo model research.
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de Graeff N, De Proost L, and Munsie M
- Published
- 2024
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32. Ethical analysis of the first porcine cardiac xenotransplantation.
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Gyngell C, Munsie M, Fujita M, Thiessen C, Savulescu J, and Konstantinov IE
- Subjects
- Animals, Humans, Swine, Informed Consent ethics, Maryland, Heterografts, Patient Compliance, Male, Tissue Donors ethics, Transplantation, Heterologous ethics, Heart Transplantation ethics, Ethical Analysis
- Abstract
In this article, we provide an ethical analysis of the first porcine cardiac xenotransplant, performed in Maryland, USA in early 2022. David Bennett was offered the experimental procedure after he was deemed ineligible for human heart transplantation and mechanical circulatory support, based on a history of non-compliance. It was reported that Mr Bennett's previous instances of non-compliance were for medically non-life-threatening conditions years earlier, where the risks of non-compliance were not as high. We argue that, in Mr Bennett's case, a history of non-compliance in a different context, should not necessarily rule him ineligible for a potentially life-saving treatment now. Furthermore, using previous non-compliance to exclude individuals from donor organs may have the unintended effect of placing the burden of testing xenotransplantation on those who are already disadvantaged. We then argue that it is not enough to rely on patient consent to ethically justify xenotransplantation research. Taking a broad ethical perspective is crucial when mapping a clinical pathway for xenotransplantation., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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33. Searching for information about stem cells online in an age of artificial intelligence: How should the stem cell community respond?
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Hoeyer K, Couturier A, Barawi K, Drew C, Grundtvig A, Lane E, Munk AK, Whiteley LE, and Munsie M
- Subjects
- Humans, Stem Cell Research, Artificial Intelligence, Internet
- Abstract
Patients and their families routinely use the Internet to learn about stem cell research. What they find, is increasingly influenced by ongoing changes in how information is filtered and presented online. This article reflects on recent developments in generative artificial intelligence and how the stem cell community should respond., Competing Interests: Declaration of interests M.M. is a board member of the International Society for Stem Cell Research (ISSCR); has been involved in the design and delivery of the ISSCR A Closer Look at Stem Cells website and ISSCR Guidelines, and is on the International Advisory Panel for EuroGCT. A.C. is a staff member of EuroGCT and serves on the Education Committee of the ISSCR., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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34. Using Google Analytics with Health Information-Seeking Model to Evaluate the Design of Health Information Websites.
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Pang PC, Munsie M, and Chang S
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- Health Behavior, Information Seeking Behavior, Search Engine
- Abstract
Health information websites can be useful for information seekers, and their design is crucial for the success of accessing the needed information. While web analytical tools (e.g. Google Analytics) used by such websites can provide descriptive measures of users, there is a disconnection between this data and the current understanding of health information-seeking behaviour. In this work, we leverage a theoretical model to interpret the Google Analytics data. Drawn on the visualisation of user behaviours based on this model, our research shows that better website design can be informed, and the evaluation of health websites can be performed on the basis of different user profiles.
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- 2024
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35. 'Ceci n'est pas un embryon?' The ethics of human embryo model research.
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de Graeff N, De Proost L, and Munsie M
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- 2023
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36. How Great a Risk Do You Take? A Qualitative Study Exploring Attitudes of Individuals with Friedreich Ataxia Toward Gene Therapy.
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Lieschke K, Scott V, Delatycki MB, Lewis S, Munsie M, Tanner C, and Corben LA
- Subjects
- Child, Humans, Adolescent, Young Adult, Adult, Australia, Friedreich Ataxia genetics, Friedreich Ataxia therapy
- Abstract
Scientists and pharmaceutical companies are working toward delivering gene therapy (GT) for Friedreich ataxia (FRDA). Understanding the views of people with lived experience of FRDA and their parents toward GT is essential to inform trial design and identify potential barriers to participation in clinical trials. The goals of this study were to identify the attitudes toward GT held by individuals with FRDA and parents of individuals with FRDA, and to explore how these may impact future trials for this condition. Audiorecorded, semistructured, qualitative interviews with 19 Australians explored experiences of FRDA, knowledge about clinical trials, views on GT, including risks and benefits, and potential barriers to participation in trials. Participants included thirteen individuals living with FRDA aged between 15-43 years, and six parents of children with FRDA aged 4-12 years of age. Thematic analysis of the interviews identified six main themes. Findings from this study indicate there is strong desire for information regarding GT in FRDA, however the current level of uncertainty around GT makes decision making challenging. The desire to maintain functional status and avoid additional risk of deterioration from an investigational treatment was apparent. Importantly, neurological targets were identified as preferred for GT trials. Further research is required to identify if attitudes and perceptions differ according to geographical location and disease stage.
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- 2023
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37. International Society for Cell & Gene Therapy Position Paper: Key considerations to support evidence-based cell and gene therapies and oppose marketing of unproven products.
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Ikonomou L, Cuende N, Forte M, Grilley BJ, Levine AD, Munsie M, Rasko JEJ, Turner L, Bidkhori HR, Ciccocioppo R, Grignon F, Srivastava A, Weiss DJ, Zettler P, and Levine BL
- Subjects
- Humans, Regenerative Medicine, Genetic Therapy, Cell- and Tissue-Based Therapy, Marketing
- Abstract
The field of regenerative medicine, including cellular immunotherapies, is on a remarkable growth trajectory. Dozens of cell-, tissue- and gene-based products have received marketing authorization worldwide while hundreds-to-thousands are either in preclinical development or under clinical investigation in phased clinical trials. However, the promise of regenerative therapies has also given rise to a global industry of direct-to-consumer offerings of prematurely commercialized cell and cell-based products with unknown safety and efficacy profiles. Since its inception, the International Society for Cell & Gene Therapy Committee on the Ethics of Cell and Gene Therapy has opposed the premature commercialization of unproven cell- and gene-based interventions and supported the development of evidence-based advanced therapy products. In the present Guide, targeted at International Society for Cell & Gene Therapy members, we analyze this industry, focusing in particular on distinctive features of unproven cell and cell-based products and the use of tokens of scientific legitimacy as persuasive marketing devices. We also provide an overview of reporting mechanisms for patients who believe they have been harmed by administration of unapproved and unproven products and suggest practical strategies to address the direct-to-consumer marketing of such products. Development of this Guide epitomizes our continued support for the ethical and rigorous development of cell and cell-based products with patient safety and therapeutic benefit as guiding principles., Competing Interests: Declaration of Competing Interest Hamid R. Bidkhori is the chancellor of the Biomedical Research Ethics Committee of Academic Center for Education, Culture and Research (ACECR) - Mashhad. He is a member of the International Society for Cell & Gene Therapy (ISCT), the International Society for Extracellular Vesicles (ISEV) and the ISCT Committee on the Ethics of Cell and Gene Therapy. Rachele Ciccocioppo is a member of the Advisory Board of Takeda (Italy) for the use of mesenchymal stromal cells in fistulizing Crohn's disease. Natividad Cuende is a member of the Governing Council of the Agencia Española de Medicamentos y Productos Sanitarios (Spanish Medicine and Medical Device Agency). She is member of the ISCT Committee on the Ethics of Cell and Gene Therapy and the ISCT Legal and Regulatory Affairs Committee–Europe. She is also member of the Spanish Guarantee Committee for Donation and Use of Human Cells and Tissues of the Spanish Ministry of Science and Innovation. She is not paid for these roles. Bambi Grilley is affiliated with QBRegulatory Consulting LLC that has provided regulatory affairs and project management support to AlloVir, Marker Therapeutics, LOKON Pharma, Tessa Therapeutics and March Biosciences. She is a member of ISCT and its Ethics of Cell and Gene Therapy (ECGT) Committee and is the incoming Chief Regulatory Officer of ISCT. She is not paid for her roles in ISCT. Conflict of interest is managed in accordance with Baylor College of Medicine policy and oversight. Laertis Ikonomou has written an expert report in a class action lawsuit filed against a business selling unproven “stem cell”-based interventions, and wrote the report on a pro bono basis. He is a member of the ISCT and the International Society for Stem Cell Research (ISSCR) and the chair of the ISCT Committee on the Ethics of Cell and Gene Therapy. He is not paid for these roles. Conflict of interest is managed in accordance with University at Buffalo policy and oversight. Aaron D. Levine is a member of ISCT and its ECGT committee. He is not paid for these roles. Levine's research program is supported by the National Science Foundation (NSF) (Grant No. EEC-1648035). Bruce Levine has received compensation for serving on the scientific advisory boards of Akron Bio, Avectas, Immuneel, Immusoft, In8bio, Ori Biotech, Oxford Biomedica, UTC Therapeutics and Vycellix. He has received compensation for consulting for GSK. He has received compensation and equity from Capstan Therapeutics as a co-founder and member of the Scientific Advisory Board. As co-founder of Tmunity Therapeutics, he received equity. Conflict of interest is managed in accordance with University of Pennsylvania policy and oversight. Megan Munsie is a member of the International Society for Stem Cell Research and its Ethics Committee and Public Policy Committee. She is also the President of the Australasian Society for Stem Cell Research. Munsie's research program is supported by the Novo Nordisk Foundation Center for Stem Cell Medicine (NNF21CC0073729). John E. J. Rasko: employment: Royal Prince Alfred Hospital; consultancy and honoraria: Rarecyte, Gilead, Roche, Novartis, Bluebird Bio, Spark therapeutics, Cynata, Pfizer; equity: Genea; shareholder: Rarecyte, Woke; DSMB: Diamond Fanconi anemia trial; research funding: National Health and Medical Research Council (NHMRC), New South Wales Cancer Council, Cancer Institute NSW (CINSW), Therapeutic Innovation Australia, Philanthropic foundations; Chair, Gene Technology Technical Advisory Committee, Office of The Gene Technology Regulator, Australian Government. Leigh Turner served as a compensated expert witness for the US government in a criminal case and as a pro bono expert witness in a class action lawsuit. He is a member of ISCT and its ECGT committee. He is also a member of the International Society for Stem Cell Research and its Ethics Committee and Membership Committee. Turner's research program is supported by the Pew Charitable Trusts. Daniel J. Weiss served as a compensated expert witness for the US government in a criminal case and as a pro bono expert witness in a class action lawsuit. He is a member of ISCT and its ECGT committee and is former Chief Scientific Officer of the ISCT. He is not paid for his roles in the ISCT. Dr. Weiss has received compensation for consulting with Mesoblast Inc., NextCell Inc., United Therapeutics. Inc. and Vertex Inc. Conflict of interest is managed in accordance with University of Vermont policy and oversight. Patricia J. Zettler reports serving as a consultant to the US Food & Drug Administration. All the other authors have no commercial, proprietary, or financial interest in the products or companies described in this article., (Copyright © 2023 International Society for Cell & Gene Therapy. Published by Elsevier Inc. All rights reserved.)
- Published
- 2023
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38. Participatory Design and Evaluation of the "Stem Cells Australia" Website for Delivering Complex Health Knowledge: Mixed Methods Study.
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Pang PC, Munsie M, Chang S, Tanner C, and Walker C
- Subjects
- Humans, Research Design, Learning, Stem Cells, Internet, Communication, Delivery of Health Care
- Abstract
Background: The internet has become a commonly used information source for people seeking to understand their health care options. However, inconsistent representation about what stem cell treatments are available and from whom, coupled with the lack of transparency about what has been shown to work or is even safe, can distract and mislead users. Given these challenges, there is a need to develop effective evidence-based tools for delivering information about health care options involving stem cells., Objective: A need to redesign an existing website in Australia was identified to provide trustworthy information about stem cell research and to counter misinformation. Using a participatory design approach to generate an understanding of what information users need for stem cell treatments, the Stem Cells Australia website serves as a case study for the development and evaluation of websites delivering complex messages about science and health., Methods: This study comprised 3 steps. First, a focus group and several one-on-one interviews with a purposive sample of users (n=12) were conducted to identify their needs and requirements. Second, we designed a new version of the website based on findings from the focus group and interviews. Finally, for evaluating the participatory design process, we collected 180 days of Google Analytics data for both the original and redesigned versions (90 days for each) and compared their differences using 2-sample z tests., Results: The feedback from participants was grouped into 3 themes-needed and unwanted information, how and where to obtain information, and their information preferences. These were translated into requirements for rebuilding the website. The redesigned version reached users in other continents, despite the daily numbers of users (-61.2%; P<.001) and sessions (-61.7%; P<.001) decreasing. The redesigned version also showed substantial decrease in daily bounce rate (-97.2%; P<.001), significant increase in the daily average of page reads per session (+110.8%; P<.001), and long daily average for session duration (+22.9%; P=.045). Navigation flow analysis showed more traffic toward web pages related to health conditions in the redesigned version., Conclusions: Websites about stem cell research need to provide content for vulnerable global audiences. Participatory design that addresses knowledge gaps and information needs can produce better performance and engagement, which can be evaluated using Google Analytics, a common web analytics tool used by many websites. Learnings for improving the metrics regarding website identity, research updates, and clinical trials are concluded, which can inform the future design of websites seeking to engage users and provide reliable and accessible science and health information including but not limited to stem cell research and therapies., (©Patrick Cheong-Iao Pang, Megan Munsie, Shanton Chang, Claire Tanner, Christine Walker. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 20.07.2023.)
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- 2023
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39. Critical considerations for public engagement in stem cell-related research.
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Sugarman J, Clark A, Fishkin J, Kato K, McCormack K, Munsie M, Peluso MJ, René N, and Solomon SL
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- Stem Cell Research, Translational Research, Biomedical
- Abstract
Public engagement is increasingly recognized as being integral to basic and translational research. Public engagement involves effective communication about research along with the mutual exchange of views and opinions among a wide variety of members in society. As such, public engagement can help to identify issues that must be addressed in order for research to be ethically sound and trustworthy. It is especially critical in research that potentially raises ethical concerns, for example research involving embryos, germline genome editing, stigmatized conditions, and marginalized communities. Therefore, it is not surprising that there have been prominent recent calls for public engagement in the emerging sciences. However, given that there is arguably little agreement about how this should be done and the best ways of doing so, those involved with planning and implementing public engagement can benefit from understanding a broad range of prior experiences on related issues., Competing Interests: Conflict of interests J.S. is a member of Merck KGaA’s Ethics Advisory Panel and Stem Cell Research Oversight Committee; a member of IQVIA’s Ethics Advisory Panel; a member of Aspen Neurosciences Clinical Advisory Panel; a member of a Merck Data Monitoring Committee; and a consultant to Biogen. None of these activities are related to the material discussed in this manuscript. A.C. is a board member of the ISSCR and is on the advisory board for Stem Cell Reports. K.K. was a member of the WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing and currently is the chair of the Ethics Committee of the ISSCR. M.M. is a board member of the health charity, National Stem Cell Foundation of Australia., (Copyright © 2023.)
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- 2023
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40. The peril of the promise of speculative cell banking: Statement from the ISCT Committee on the Ethics of Cell and Gene Therapy.
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Levine BL, Munsie M, Levine AD, and Ikonomou L
- Subjects
- Genetic Therapy
- Published
- 2022
- Full Text
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41. Academic Physician Specialists' Approaches to Counseling Patients Interested in Unproven Stem Cell and Regenerative Therapies-A Qualitative Analysis.
- Author
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Smith C, Crowley A, Munsie M, Behfar A, DeMartino ES, Staff NP, Shapiro SA, and Master Z
- Subjects
- Humans, Interviews as Topic, Patient Education as Topic methods, Physician-Patient Relations, Physicians, Qualitative Research, Referral and Consultation, Counseling methods, Regenerative Medicine, Stem Cell Transplantation psychology, Therapies, Investigational adverse effects, Therapies, Investigational psychology
- Abstract
Objective: To explore the experiences, approaches, and challenges of physicians consulting patients about experimental stem cell and regenerative medicine interventions (SCRIs)., Participants and Methods: From August 21, 2018, through July 30, 2019, semistructured interviews of 25 specialists in cardiology, ophthalmology, orthopedics, pulmonology, and neurology were conducted and qualitatively analyzed using modified grounded theory., Results: All specialists used informational approaches to counsel patients, especially orthopedists. Informational approaches included explaining stem cell science, sharing risks, and providing principles. Several specialists also used relational counseling approaches including emphasizing that physicians want what is best for patients, acknowledging suffering, reassuring continued care, empathizing with patients and families, and underscoring that patients have the final decision. Many specialists reported being comfortable with the conversation, although some were less comfortable and several noted challenges in the consultation including wanting to support a patient's decision but worrying about harms from unproven SCRIs, navigating family pressure, and addressing stem cell hype and unrealistic expectations. Specialists also desired that additional resources be available for them and patients., Conclusion: Physicians relied more heavily on providing patients with information about SCRIs than using relational counseling approaches. Efforts should be directed at helping physicians address the informational and relational needs of patients, including providing tools and resources that inform physicians about the unproven SCRI industry, building skills in empathic communication, and the creation and dissemination of evidence-based resources to offer patients., (Copyright © 2021 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
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42. Ethical issues and public communication in the development of cell-based treatments for COVID-19: Lessons from the pandemic.
- Author
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Turner L, Munsie M, Levine AD, and Ikonomou L
- Subjects
- Humans, COVID-19 therapy, Communication, Pandemics ethics, SARS-CoV-2, Stem Cell Transplantation ethics, Therapeutics ethics
- Abstract
The significant morbidity and mortality of coronavirus disease 19 (COVID-19) prompted a global race to develop new therapies. These include interventions using cell- or cell-derived products, several of which are being tested in well-designed, properly controlled clinical trials. Yet, the search for cell-based COVID-19 treatments has also been fraught with hyperbolic claims; flouting of crucial regulatory, scientific, and ethical norms; and distorted communication of research findings. In this paper, we critically examine ethical issues and public communication challenges related to the development of cell-based therapeutics for COVID-19. Drawing on the lessons learned from this ongoing process, we argue against the rushed development of cell-based interventions. We conclude by outlining ways to improve the ethical conduct of cell-based clinical investigations and public communication of therapeutic claims., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
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43. Regulating autologous stem cell interventions in Australia: updated review of the direct-to-consumer advertising restrictions.
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Rudge C, Ghinea N, Munsie M, and Stewart C
- Subjects
- Advertising, Australia, Humans, Stem Cells, Direct-to-Consumer Advertising
- Abstract
Objective This paper provides an update and overview of the law governing direct-to-consumer (DTC) advertising of autologous stem cell interventions (ASCIs) in Australia. It follows significant changes to the advertising regulations made in 2018. Methods The paper reviews the three primary sources or 'centres' of law regulating ASCIs in Australia, together with the relevant guidance documents that supplement these sources. It provides analysis of how the post-2018 advertising regulations, contained in the Therapeutic Goods Act 1989 (Cwlth), apply to all 'biologicals', including ASCIs. It demonstrates how these three sources of law interact with one another and outlines the new tiered offence regime that applies to contraventions of these prohibitions. Results The analysis demonstrates that DTC advertising of ASCIs in Australia is strictly controlled, with primary legislation prohibiting the advertising of biologicals altogether. Conclusions The polycentric legal regime regulating biologicals in Australia clearly makes DTC advertising of ASCIs unlawful. Health practitioners who promote ASCIs, either online, in print or in other media forms, may be penalised in different ways and by different authorities. What is known about the topic? Although several analyses have examined the regulation of ASCIs in Australia, no analysis has studied the reforms made in 2018 relating to the advertising of biologicals. As such, this analysis contributes a fresh examination of these relatively recent reforms. What does this paper add? This analysis clarifies the effects of these new advertising regulations, providing clear guidance on the relevant legal provisions for the benefit of health practitioners and health professionals more generally. What are the implications for practitioners? Health practitioners, especially those who offer ASCIs, should be aware that civil and criminal penalties are likely to be imposed on individuals who promote biologicals in Australia by any means.
- Published
- 2021
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44. Academic physician specialists' views toward the unproven stem cell intervention industry: areas of common ground and divergence.
- Author
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Smith C, Crowley A, Munsie M, DeMartino ES, Staff NP, Shapiro S, and Master Z
- Subjects
- Humans, Stem Cells, Physicians, Specialization
- Abstract
Background and Aims: Premature commercialization of unproven stem cell interventions (SCIs) has received significant attention within the regenerative medicine community. Patients considering SCIs may encounter misinformation and seek out guidance from their physicians who are trusted brokers of health information. However, little is known about the perspectives of academic physician specialists toward the SCI industry. The purpose of this study was to capture the attitudes of physician specialists with experience addressing patient questions about unproven SCIs., Methods: The authors undertook 25 semi-structured interviews with academic physicians in cardiology, ophthalmology, orthopedics, pulmonology and neurology primarily from one academic center., Results: The authors identified two major themes: concerns and mediators of appropriateness of offering SCIs as therapies to patients. Specialists were generally aware of the industry and reported scientific and commercial concerns, including the scientific uncertainty of SCIs, medical harms to patients, misleading marketing and its impact on patient informed consent and economic harms due to large out-of-pocket costs for patients. All specialists outside of orthopedics voiced that it was inappropriate to be offering SCIs to patients today. These views were informed by previously expressed concerns surrounding safety and properly informing patients, levels of evidence needed prior to offering SCIs therapeutically and desired qualifications for clinicians. Among the specialties, orthopedists reported that under certain conditions, SCIs may be appropriate for patients with limited clinical options but only when safety is adequate, expectations are managed and patients are well informed about the risks and chances of benefit. Most participants expressed a desire for phase 3 studies and Food and Drug Administration approval prior to marketing SCIs, but some also shared the challenges associated with upholding these thresholds of evidence, especially when caring for out-of-option patients., Conclusions: The authors' results suggest that medical specialists are aware of the industry and express several concerns surrounding SCIs but differ in their views on the appropriateness and clinical evidence necessary for offering SCIs currently to patients. Additional educational tools may help physicians with patient engagement and expectation management surrounding SCIs., (Copyright © 2021 International Society for Cell & Gene Therapy. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
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45. From the margins to mainstream: How providers of autologous 'stem cell treatments' legitimise their practice in Australia.
- Author
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MacGregor C, Petersen A, and Munsie M
- Subjects
- Australia, Biomedical Research standards, Communication, Direct-to-Consumer Advertising, Humans, Internet, Physicians economics, Stem Cell Transplantation adverse effects, Bioethics, Medical Tourism economics, Physicians standards, Stem Cell Transplantation legislation & jurisprudence, Stem Cell Transplantation standards
- Abstract
This article examines how Australian providers of unproven autologous 'stem cell treatments' legitimise these products and their practices. We focus on the strategies employed by providers in their efforts to create and sustain a market for procedures that have yet to be proven safe and clinically efficacious. Drawing on the work of Thomas Gieryn and Pierre Bourdieu and the findings of research involving an analysis of direct-to-consumer online advertising of clinics that sell purported 'stem cell treatments' and interviews with clinicians who provide them, we examine the mechanisms by which medical legitimacy for these products is established and defended. We argue that Australian providers employ a number of strategies in order to create medical legitimacy for the use and sale of scientifically unproven therapies. A key strategy employed by providers of stem cell treatments is to use markers of social distinction, drawing strongly on the symbols of science, to confirm their legitimacy and differentiate their own practices from those of other providers, who are posited as operating outside the boundary of accepted practice and hence illegitimate. We argue there is a paradox at the heart of the autologous stem cell treatment market. Providers aim to create legitimacy for their work by emphasising the potential benefits of their 'treatments', their expertise and the professionalisation of their practices in an environment where regulators are yet to take a firm stance; they are also required to undertake the challenging task of managing patients' hopes and expectations that both enable and potentially jeopardise their operations and revenue. We conclude by suggesting that providers' creation of symbolic capital to establish medical legitimacy is a crucial means by which they seek to bring unproven 'stem cell treatments' from the margins of medicine into the mainstream and to portray themselves as medical pioneers rather than medical cowboys who exploit vulnerable patients.
- Published
- 2021
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46. Unconventional Practice, "Innovative" Interventions and the National Law.
- Author
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Stewart C, Kerridge I, Waldby C, Lipworth W, Munsie M, Lysaght T, Rudge C, Ghinea N, Eckstein L, Neilsen J, Kaldor J, and Nicol D
- Subjects
- Australia, Humans, Health Personnel
- Abstract
This column explores a recent health profession disciplinary case which throws light on the problems of unconventional interventions by medical practitioners under the Health Practitioner Regulation National Law Act 2009 (Qld). The case involved "innovative" practices which were later found to have been scientifically unsupported, dangerous to patients and grounds for cancelling the health practitioner's registration. This column looks at common features of these kinds of cases in Australia and then examines recent attempts by the Medical Board of Australia to draft policy guidance around the use of unconventional practice in medicine. This column concludes with a number of changes to improve the effectiveness of the proposed policy., Competing Interests: None.
- Published
- 2020
47. Toward Guidelines for Research on Human Embryo Models Formed from Stem Cells.
- Author
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Hyun I, Munsie M, Pera MF, Rivron NC, and Rossant J
- Subjects
- Humans, Internationality, Embryo Research ethics, Embryo, Mammalian cytology, Guidelines as Topic, Models, Biological, Stem Cells cytology
- Abstract
Over the past few years, a number of research groups have reported striking progress on the generation of in vitro models from mouse and human stem cells that replicate aspects of early embryonic development. Not only do these models reproduce some key cell fate decisions but, especially in the mouse system, they also mimic the spatiotemporal arrangements of embryonic and extraembryonic tissues that are required for developmental patterning and implantation in the uterus. If such models could be developed for the early human embryo, they would have great potential benefits for understanding early human development, for biomedical science, and for reducing the use of animals and human embryos in research. However, guidelines for the ethical conduct of this line of work are at present not well defined. In this Forum article, we discuss some key aspects of this emerging area of research and provide some recommendations for its ethical oversight., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2020
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48. Australian regulation of autologous human cell and tissue products: implications for commercial stem cell clinics.
- Author
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Ghinea N, Munsie M, Rudge C, and Stewart C
- Subjects
- Australia, Government Regulation, Humans, Quality Assurance, Health Care standards, Stem Cell Transplantation standards, Advertising legislation & jurisprudence, Cell- and Tissue-Based Therapy standards, Marketing of Health Services legislation & jurisprudence, Practice Guidelines as Topic standards, Quality Assurance, Health Care legislation & jurisprudence, Stem Cell Transplantation legislation & jurisprudence, Stem Cells cytology
- Abstract
In 2018, Australia's Therapeutic Goods Administration introduced regulatory reforms that set stricter criteria around the regulation of products derived from a patient's own cells and tissues, posing significant implications for clinics offering stem cell treatments. We review the regulatory framework and discuss its potential commercial implications, including the ambiguities that may arise from it in practice, as well as the likely impact it will have on product development and advertising practices in the future.
- Published
- 2020
- Full Text
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49. The direct-to-consumer market for stem cell-based interventions in Australia: exploring the experiences of patients.
- Author
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Waldby C, Hendl T, Kerridge I, Lipworth W, Lysaght T, Munsie M, and Stewart C
- Subjects
- Direct-to-Consumer Advertising legislation & jurisprudence, Direct-to-Consumer Advertising trends, Female, Humans, Interviews as Topic, Male, Marketing of Health Services legislation & jurisprudence, Marketing of Health Services trends, Middle Aged, Stem Cell Transplantation legislation & jurisprudence, Stem Cell Transplantation trends, Transplantation, Autologous, Direct-to-Consumer Advertising standards, Marketing of Health Services standards, Stem Cell Transplantation standards, Stem Cells cytology
- Abstract
The prevalence of businesses selling autologous stem cell-based interventions to patients in Australia has raised serious concerns about how weaknesses in regulation have enabled the emergence of an industry that engages in aggressive marketing of unproven treatments to patients. Little is known about how patients experience this marketing and their subsequent interactions with practitioners. This paper reports results from 15 semistructured interviews with patients and carers, and also draws upon discussion conducted with patients, carers and family members (22 participants) in a workshop setting. We explore how Australian patients and carers understand and experience these interventions, and how their presumptions about the ethics of medical practice, and the regulatory environment in Australia have conditioned their preparedness to undergo unproven treatments.
- Published
- 2020
- Full Text
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50. Contact us for more information: an analysis of public enquiries about stem cells.
- Author
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Zarzeczny A, Tanner C, Barfoot J, Blackburn C, Couturier A, and Munsie M
- Subjects
- Humans, Public Health, Information Dissemination methods, Information Seeking Behavior, Internet standards, Stem Cell Research, Stem Cells, Therapies, Investigational statistics & numerical data, Trust
- Abstract
Aim: This study examines online enquiries received by two prominent stem cell science initiatives operating in different geographical jurisdictions. Materials & methods: Combined quantitative and qualitative analysis undertaken of internet-based queries (n = 1047) received by Stem Cells Australia and EuroStemCell from members of the public over a two-year period (May 2014-2016). Results: Findings reveal striking similarities between the two datasets and highlight the range of uncertainties, priorities and needs of those seeking information about stem cells online. Conclusion: Sustained and in-depth tailored guidance is needed to effectively meet the diverse stem cell-related information-based needs of communities internationally. Such efforts should be prioritized by regenerative medicine research initiatives and organizations, given the trust and hope diverse publics appear to place in these groups.
- Published
- 2019
- Full Text
- View/download PDF
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