Earlier this year, the Australian Therapeutic Goods Administration (TGA) solicited input from interested parties about the regulation of autologous cell and tissue products. The ISSCR’s comments addressed the options that were presented in a 2016 Consultation Paper.
In its comments, the ISSCR supported Option 4, which would require regulation of autologous products that involve more than minimal manipulation of a patient’s cells and place strict limitations on the direct advertisement of cell-based therapies. This is the highest level of regulatory oversight put forward in the Consultation Paper.
The ISSCR continues to highlight the importance for proactive regulatory oversight for the use and marketing of autologous stem cell-based interventions. The proliferation of clinics offering unproven ‘stem cell’ interventions over the last five years is of concern to the ISSCR, which advocates that stem cell therapies provided to patients be evidence-based. In supporting option 4, the ISSCR cites several recommendations made in its 2016 Guidelines for Stem Cell Research and Clinical Translation, an overarching principle of which is that therapies should only be sold to patients after safety and effectiveness have been established in clinical trials, with institutional and regulatory oversight, peer-review, and systematic reporting of results.
Note: In 2013, the ISSCR called for proactive regulatory oversight for processing or manipulation of any medical product, including autologous cell based therapies.