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Self-regulation of autologous cell therapies

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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.

Our concern remains that this is an unregulated industry, and thus self-regulation seemed a sensible first step to reduce risk. Indeed it is astonishing to note the differences in regulation between Australia and the United States, which recently reaffirmed the Food and Drug Administration’s oversight of certain autologous cell therapies in the US Court of Appeals.1

If adverse events arise from the use of autologous cells in Australia, all practitioners of the art are likely to be adversely affected. It is in the interest of all — companies, clinicians and their patients — to limit the risks of this unregulated industry.