The ISSCR appreciates the new framework proposed by Australia’s Therapeutic Goods Administration (TGA) for the regulation of human cell and tissue products that use a person’s own cells (‘autologous use’). These new
“Australia’s new regulatory framework will protect patients from unproven therapies marketed as stem cell treatments,” said ISSCR President Hans Clevers. “It aligns the country’s rules with those of the European Union and the United States, which regulate stem cell therapies as biologics, requiring safety and efficacy testing before commercialization,” he said. “We also support the TGA’s prohibition on marketing and selling autologous human cell and tissue products to patients, and appreciate the specific guidance regarding adipose tissue, a common source of cells and tissue used for unproven therapies marketed as stem cell treatments,” he said.
In its 2016 Guidelines for Stem Cell Research and Clinical Translation, the ISSCR encourages regulators around the world to modernize regulation of stem cell products in order to protect patients from potentially risky cell-based interventions that have not yet been tested in peer-reviewed clinical trials to assess safety and efficacy.
In March 2018, the ISSCR urged the Australian TGA to carefully draft guidelines to allow common medical procedures like skin grafts and breast reconstructions to continue, while more stringently regulating complex and more speculative therapies as biological products. In additional comments to the TGA, the ISSCR supported placing strict limits on the marketing and sale of stem cell therapies until their safety and effectiveness is established in regulated clinical trials.