Marketing of unproven stem cell–based interventions: A call to action

Sipp, Douglas; Caulfield, Timothy; Kaye, Jane; Barfoot, Jan; Blackburn, C. Clare; Chan, Sarah; Luca, Michele De; Kent, Alastair; McCabe, Christopher; Munsie, Megan; Sleeboom-Faulkner, Margaret; Sugarman, Jeremy; Zimmeren, Esther van; Zarzeczny, Amy; Rasko, John E.J.

doi:10.1126/scitranslmed.aag0426

Cited by 161 publications

(121 citation statements)

References 28 publications

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“…In addition, ethical considerations are a necessity when translating research from the bench to bedside. Furthermore, governmental restrictions and regulations may negatively affect the speed of translation of stem cell therapy into clinical practice . Strategies to manipulate cells using genetic and viral transduction approaches in vitro to potentially enhance their effect in vivo (as recently reviewed) raise additional regulatory considerations.…”

Section: Current State Of Clinical Translationmentioning

confidence: 99%

Stem‐cell–based therapies to enhance peripheral nerve regeneration

et al. 2019

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Peripheral nerve injury remains a major cause of morbidity in trauma patients. Despite advances in microsurgical techniques and improved understanding of nerve regeneration, obtaining satisfactory outcomes after peripheral nerve injury remains a difficult clinical problem. There is a growing body of evidence in preclinical animal studies demonstrating the supportive role of stem cells in peripheral nerve regeneration after injury. The characteristics of both mesoderm‐derived and ectoderm‐derived stem cell types and their role in peripheral nerve regeneration are discussed, specifically focusing on the presentation of both foundational laboratory studies and translational applications. The current state of clinical translation is presented, with an emphasis on both ethical considerations of using stems cells in humans and current governmental regulatory policies. Current advancements in cell‐based therapies represent a promising future with regard to supporting nerve regeneration and achieving significant functional recovery after debilitating nerve injuries.

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Section: Current State Of Clinical Translationmentioning

confidence: 99%

Stem‐cell–based therapies to enhance peripheral nerve regeneration

et al. 2019

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“…As reported by Dominique McMahon,38 a global industry of rogue stem cell clinics has emerged since the mid‐2000s. Hundreds of clinics in numerous countries, including the United States and other high‐income countries, offer unauthorized stem cell interventions whose safety and effectiveness have not been systemically proven 39…”

Section: Challenges For Fertility Patients and Babiesmentioning

confidence: 99%

“…Moreover, the expansion of the Internet and social media have created new possibilities for the marketing of reproductive and therapeutic services. The ability of online advertising to reach worldwide audiences makes the enforcement of national laws more difficult, if not impossible 49. Due to the decentralized and borderless nature of the Internet and to more affordable international travel, national governments alone cannot solve the problem of irresponsible, transnational advertising practices 50…”

Section: Policy Optionsmentioning

confidence: 99%

Heritable Genome Editing in a Global Context: National and International Policy Challenges

Rosemann¹,

Balen²,

Nerlich³

et al. 2019

Hastings Center Report

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A central problem for the international governance of heritable germline gene editing is that there are important differences in attitudes and values as well as ethical and health care considerations around the world. These differences are reflected in a complicated and diverse regulatory landscape. Several publications have discussed whether reproductive uses would be legally permissible in individual countries and whether clinical applications could emerge in the context of regulatory gaps and gray areas. Systematic comparative studies that explore issues related to the governance of this technology from different national and international perspectives are needed to address the lack of knowledge in this area. In this research report, we contribute to filling this gap by presenting views of stakeholders in the United Kingdom on challenges to the governance of heritable genome editing. We present findings from a multistakeholder study conducted in the United Kingdom between October 2016 and January 2018 and funded by the Wellcome Trust. This research included interviews, literature analysis, and a workshop. We involved leading U.K. scientists, in vitro fertilization clinicians, and representatives from regulatory bodies, patient organizations, and other civil societal organizations, as well as fertility companies. Part one of this article explores stakeholder perceptions of possible global developments in heritable genome editing and associated risks and governance challenges. Part two presents a range of policy options that were generated during the workshop in relation to the challenges discussed in part one.

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“…To date, efforts to regulate this global problem have had little success4 and, whilst patient autonomy must be respected, clinicians also have a responsibility to discuss potential risks and to advise patients against interventions considered inappropriate, unproven and potentially harmful. However, while neurologists may understand the level of evidence for stem cell therapy, they may be less familiar with the procedures and risks associated with transplantation, and with internationally agreed standards for transplant centres.…”

Section: Introductionmentioning

confidence: 99%

Advising patients seeking stem cell interventions for multiple sclerosis

et al. 2018

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Given the intuitive potential of stem cell therapy and limitations of current treatment options for progressive multiple sclerosis (MS), it is not surprising that patients consider undertaking significant clinical and financial risks to access stem cell transplantation. However, while increasing evidence supports autologous haematopoietic stem cell transplantation (AHSCT) in aggressive relapsing-remitting MS, interventions employing haematopoietic or other stem cells should otherwise be considered experimental and recommended only in the context of a properly regulated clinical study. Understandably, most neurologists are unfamiliar with AHSCT procedures and the specific requirements for quality assurance and safety standards, as well as post-procedure precautions and follow-up. Consequently they may feel ill-equipped to advise patients. Here, we highlight important points for discussion in consultations with patients considering stem cell 'tourism' for MS.

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Marketing of unproven stem cell–based interventions: A call to action

Abstract: Commercial promotion of unsupported therapeutic uses of stem cells is a global problem that should be addressed by coordinated approaches at the national and international levels.

Cited by 161 publications

References 28 publications

Stem‐cell–based therapies to enhance peripheral nerve regeneration

Stem‐cell–based therapies to enhance peripheral nerve regeneration

Heritable Genome Editing in a Global Context: National and International Policy Challenges

Advising patients seeking stem cell interventions for multiple sclerosis

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