Letters
Health services administration
Volume 201 - Issue 9

Self-regulation of autologous cell therapies

Authors:  Bernard E Tuch and Dominic Wall

Med J Aust 2014; 201 (9): 514-516. || doi: 10.5694/mja14.01069
Published online: 3 November 2014
In reply: It is in the interest of all to limit the risks of this unregulated industry
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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.

Authors

  • Bernard E Tuch1,2
  • Dominic Wall3,4
  • 1. NSW Stem Cell Network, Sydney, NSW.
  • 2. Centre for Genetic Diseases, Monash Institute of Medical Research, Monash University, Melbourne, VIC.
  • 3. Australia and New Zealand Region, International Society for Cellular Therapy, Melbourne, VIC.
  • 4. Department of Pathology, University of Melbourne, Melbourne, VIC.

Correspondence: b.tuch@stemcellnetwork.org.au

Competing interests

No relevant disclosures.

References

View this article on Wiley Online Library

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