Log in with your email address username.

×

Attention doctorportal newsletter subscribers,

After December 2018, we will be moving elements from the doctorportal newsletter to MJA InSight newsletter and rebranding it to Insight+. If you’d like to continue to receive a newsletter covering the latest on research and perspectives in the medical industry, please subscribe to the Insight+ newsletter here.

As of January 2019, we will no longer be sending out the doctorportal email newsletter. The final issue of this newsletter will be distributed on 13 December 2018. Articles from this issue will be available to view online until 31 December 2018.

Self-regulation of autologous cell therapies

- Featured Image

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.

email