- Editors' Introduction to the Special Section on Ethics, Policy, and Autologous Cellular Therapies
Bioethical, legal, and professional discussions concerning human stem cell science have moved away from the contentious, and possibly irreconcilable, debates about human embryos to other sources of pluripotent stem cells. While there is an array of ethical and legal issues associated with all types of pluripotent stem cells (Sugarman 2008), in recent years complex issues have arisen with regard to the premature use of somatic or "adult" stem cells. Of particular concern is the global emergence of an industry selling products and services marketed as stem cells direct to the consumer, typically over the internet, for a range of serious medical conditions that lack credible evidence of safety and efficacy (Sipp et al. 2017). The worries are that such practices are placing patients at risk of unnecessary harms and are exploiting vulnerable populations with unsubstantiated claims of clinical benefit.
This industry has emerged over the last decade from the edges of medical tourism to penetrate the global marketplace (Regenberg et al. 2009). An international study published by Berger and colleagues (2016) identified 417 unique websites marketing stem cell products and services, with almost half (44.7%) of those being from the United States; the rest were distributed across countries as diverse as India (35), Mexico (28), China (23), Australia (19), the United Kingdom (16), Germany (11), and Japan (4). Other evaluations indicate that these figures are conservative and underestimate the size of the industry. Specifically, a concurrently published study identified 351 websites marketing putative stem cell therapies [End Page 1] at 570 clinics across the United States (Turner and Knoepfler 2016). Both studies found that, where stated, the majority of those clinics are administering autologous stem cells. Unlike allogeneic cells, which come from another donor, autologous stem cells come from the patient who receives them. Furthermore, a comparative study of websites marketing autologous stem cells in Australia and Japan also identified higher numbers than previously reported, with 70 clinics in Australia and 88 in Japan (Berger et al. 2016; Fujita et al. 2016; McLean, Stewart, and Kerridge 2014; Munsie and Pera 2014; Munsie et al. 2017).
In addition to cosmetic applications, the industry is marketing autologous stem cells for serious medical conditions that vary widely, from muscle and tendon injuries and osteoarthritis to heart disease, diabetes, spinal cord injury, and neurological disorders, to name but a few (Berger et al. 2016; Munsie et al. 2017; Turner and Knoepfler 2016). Yet the efficacy and safety profile of many these approaches is not well supported by scientific evidence, nor is the assumption that explanted stem cells can home in and effectively repair tissue damage, which are important components of the rationale for using them (Marks, Witten, and Califf 2017). Even though autologous stem cells lack the safety issues typically associated with the immune-raising responses of allogeniec cells, their clinical use is not without serious risks. Indeed, reports of deaths and severe injuries attest to the need for effective regulation and oversight of this industry (Cyranoski 2010; Freeman 2014; Kuriyan et al. 2017; Lysaght et al. 2017; Tuffs 2010).
Globally, stem cells generally fall within regulatory frameworks for the marketing of biological and drug products. However, within these frameworks are mechanisms that exclude or exempt from regulation certain uses of autologous stem cells within the practice of medicine—for example, rescuing bone marrow function with stem cell transplantation following high-dose chemotherapy for the treatment of blood cancers. These mechanisms vary slightly across international jurisdictions, but in general they have enabled the industry to focus on providing autologous stem cells to patients primarily within the context of private clinical practices, where drug regulators lack authority (Lysaght et al. 2017). However, the clinical use of biological drugs, cells, and tissues, still falls under the governance frameworks that regulate the medical profession (Taylor 2010). And while professional governance bodies in some countries have taken action against practitioners for misleading or outright deceptive claims, the effects of these cases on the industry as a whole seems to be negligible (Lysaght et al. 2017).
Despite the potential impacts of this industry on patients, health-care systems, and...