Finally, unproven stem cell clinic practices might be curtailed

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

Tempering hope with realism. Induced pluripotent stem cells in regenerative medicine

• 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

A Supercooled Spin Liquid State in the Frustrated Pyrochlore Dy2Ti2O7

A "supercooled" liquid develops when a fluid does not crystallize upon cooling below its ordering temperature. Instead, the microscopic relaxation times diverge so rapidly that, upon further cooling, equilibration eventually becomes impossible and glass formation occurs. Classic supercooled liquids exhibit specific identifiers including microscopic relaxation times diverging on a Vogel-Tammann-Fulcher (VTF) trajectory, a Havriliak-Negami (HN) form for the dielectric function, and a general Kohlrausch-Williams-Watts (KWW) form for time-domain relaxation. Recently, the pyrochlore Dy2Ti2O7 has become of interest because its frustrated magnetic interactions may, in theory, lead to highly exotic magnetic fluids. However, its true magnetic state at low temperatures has proven very difficult to identify unambiguously. Here we introduce high-precision, boundary-free magnetization transport techniques based upon toroidal geometries and gain a fundamentally new understanding of the time- and frequency-dependent magnetization dynamics of Dy2Ti2O7. We demonstrate a virtually universal HN form for the magnetic susceptibility, a general KWW form for the real-time magnetic relaxation, and a divergence of the microscopic magnetic relaxation rates with precisely the VTF trajectory. Low temperature Dy2Ti2O7 therefore exhibits the characteristics of a supercooled magnetic liquid; the consequent implication is that this translationally invariant lattice of strongly correlated spins is evolving towards an unprecedented magnetic glass state, perhaps due to many-body localization of spin.Comment: Version 2 updates: added legend for data in Figures 4A and 4B; corrected equation reference in caption for Figure 4

Developing a Reflexive, Anticipatory, and Deliberative Approach to Unanticipated Discoveries: Ethical Lessons from iBlastoids

In this paper, we explore the recent creation of “iBlastoids,” which are 3-D structures that resemble early human embryos prior to implantation which formed via self-organization of reprogrammed adult skin cells. We explore some of the ethical, philosophical, social, and regulatory issues related to this research, with focus particularly on what it means to “anticipate” research outcomes when using novel methods or when serendipitous discoveries are made. We defend the need for reflexive, anticipatory, and deliberative ethical and conceptual work by researchers working in emerging and contentious research domains, in collaboration with interdisciplinary scholars, as well as regulators, funders, and publics.Rachel A. Ankeny, Megan J. Munsie and Joan Leac

The Stem Cell “Sell”

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

Regulating the Stem Cell Industry: Needs and Responsibilities

Emerging biotechnologies pose public health challenges1 because of both the known and unforeseen risks they carry, the uncertain medical benefits they offer, the speed at which they have disseminated and their unproven mode of application.2 The development of therapies from advances in stem cell science reveals the need to pay critical attention to stem cell treatments. Stem cells have attracted scientific, clinical and public interest because they are self-renewing and have the capacity to develop into specific cell types, depending on the source of stem cells and their biological plasticity. The hope is that stem cells could be used either to replace damaged cells or to create an environment for cellular regeneration to treat several conditions, including osteoarthritis, diabetes, macular degeneration and Parkinson disease. Although promising in theory, so far very few stem cell therapies have proven to be safe and effective in clinical trials. Yet, despite the absence of evidence to support their use, there has been a global proliferation of clinics and associated businesses offering stem cell-based interventions to patients having serious medical conditions.3 These clinics operate mostly in the private health-care sector and typically market their interventions directly to patients over the Internet. The emergence of these clinics has not only created domestic markets in many highincome countries,3 but has also fomented stem cell tourism – the movement of people across international boundaries to access putative stem cell treatments. The global reach of this expanding industry exploits weaknesses and differences in national regulatory infrastructures4 and has revealed the need for an international approach to report and monitor the harms and benefits of these putative treatments