Stemming the tide of unproven autologous stem cell therapies in Australia

There is an increasingly alarming number of for-profit private clinics offering unproven stem cell medical treatments to vulnerable patients all over the world including Australia. There were accounts of unsubstantiated claims of cures and adverse events. Previously, these untested stem cell treatments were available primarily in developing countries with less regulation or weak enforcement. However, since 2011, Australia too has stem cell businesses offering autologous stem cell treatments (that is, stem cells from the patient's own body, not donated cells), and they have grown to more than 70. This country has among the world's highest concentration of stem cell clinics, with websites advertising medical procedures (such as for the treatment of sports injuries, stroke, osteoarthritis, and so forth) as well as anti-ageing therapies (such as facial rejuvenation). While there are various forms of regulation to govern stem cell therapies such as the traditional law and professional guidelines, they are ineffective and failing to protect vulnerable patients. In October 2017, the Therapeutic Goods Administration ('TGA') announced that there are proposed amendments to the Therapeutic Goods Regulations 1990 (Cth) to introduce regulatory requirements around the autologous human cell and tissue therapies including stem cells in 2018. It is anticipated that the proposed changes are likely to close the regulatory gap and thus this long-awaited control is welcomed.