• Stem Cell Res Ther · Nov 2018

    Review

    Overcoming barriers to facilitate the regulation of multi-centre regenerative medicine clinical trials.

    • Erika Kleiderman, Audrey Boily, Craig Hasilo, and Bartha Maria Knoppers.
    • Centre of Genomics and Policy, Department of Human Genetics, McGill University, Montreal, QC, H3A 0G1, Canada. erika.kleiderman@mcgill.ca.
    • Stem Cell Res Ther. 2018 Nov 8; 9 (1): 307.

    AbstractIn the context of regenerative medicine and cellular therapies, the treatment under study often targets a less common disease or condition for which recruitment of a large number of research participants at any given site is challenging, if not impossible. One way to overcome this challenge is with a multi-centre clinical trial. This manuscript first aims to briefly outline the existing ethical, legal and social implications as well as the regulatory frameworks associated with multi-centre regenerative medicine clinical trials. Second, it considers the regulatory limitations and barriers surrounding the initiation of such trials in Canada, the USA and Europe. Third, it concludes with a set of recommendations for facilitating multi-centre clinical trials, at both national and international levels.

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