PerspectiveStem Cells

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

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Science Translational Medicine  05 Jul 2017:
Vol. 9, Issue 397, eaag0426
DOI: 10.1126/scitranslmed.aag0426

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  • RE: “Marketing of unproven stem cell–based interventions: A call to action” Sipp et al.,
    • Alessondra T Speidel, Completed English version of manuscript, and added some references, Department of Medical Biochemistry and Biophysics, Karolinska Institute, Stockholm, Sweden
    • Other Contributors:
      • Kazuo Yano, Provided information on regulations of regenerative medicine, Institute of Advanced Biomedical Engineering and Science, Tokyo Women’s Medical University, Tokyo, Japan
      • Masayuki Yamato, Made a draft of the manuscript, and the corresponding author, Institute of Advanced Biomedical Engineering and Science, Tokyo Women’s Medical University, Tokyo, Japan

    Regulatory authorities, such as those in Japan (Pharmaceuticals and Medical Devices Agency; PMDA, Ministry of Health Labour and Welfare; MHLW), the US (Food and Drug Administration; FDA), and the EU (European Medicines Agency; EMA), each have their own unique legislation for the regulation of cell therapy; however, these bodies are only effective domestically. There are some international collaborations for the codification of medical device regulations, such as the Global Harmonization Task Force (GHTF),which was disbanded in 2012 and was renamed as International Medical Device Regulators Forum (IMDRF), and the US – Japan Medical Device Harmonization by Doing (HBD)[1]. There are also international collaborations for codification of pharmaceutical regulations and registration, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)[2]. However, no such international collaborations yet exist for cell therapies. As the article by Douglas Sipp, et al, (“Marketing of unproven stem cell-based interventions: A call to action”, Science Translational Medicine, 5 Jul 2017, Vol. 9, Issue 397) mentions, international regulation is needed, but we cannot expect such existing regulatory bodies to make internationally effective and coherent regulation. The World Health Organization (WHO) seems capable of having such responsibility, as suggested by the article, but currently no action has been undertaken to indoctrinate such...

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    Competing Interests: None declared.