In reply: We agree with Vesey on the need for clinical governance, but urge him to remain involved with the development of a national code of conduct in this area. His company's experience would be invaluable. Our observations regarding self-regulation were qualified because, unlike the fertility treatments, many of the therapeutic claims of autologous cell therapies are unproven. Consequently, there should be a goal of developing an evidence framework.
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- 1. United States of America v Regenerative Sciences, LLC, et al, 12-5254 (DC Cir 2014).
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