Academy calls for tighter stem cell therapy regulation

The Australian Academy of Science has responded to the TGA’s review into the regulation of autologous stem cell therapies, calling for the closure of a loophole which apparently allows practitioners to offer experimental and potentially risky therapies to vulnerable patients.

Human cell and tissue products (HCTs) can be derived and used as part of medical practice or supplied as products manufactured for therapeutic use. Autologous cells are those that are removed from, and applied to, the same person.

The autologous HCTs under consideration are those that are taken from a patient and used under the supervision of a medical practitioner who is caring for that patient for a single indication in a single course of treatment. These are captured under Therapeutic Goods (Excluded Goods) Order No. 1 of 2011, meaning they are declared not to be therapeutic goods for the purpose of the Therapeutic Goods Act 1989 and not regulated by the TGA.

Medical practitioners currently use autologous HCTs as part of a range of proven treatments, including bone marrow transplants and heart bypass surgery. However, some unethical practitioners are using this loophole to treat patients with conditions like cancer, Alzheimer’s disease and multiple sclerosis.

The Australian Academy of Science recommends that all doctors using human tissue for treatment purposes comply with the strongest standards of manufacturing safety and evidence-based medicine. According to the chair of the academy’s National Committee for Cellular and Developmental Biology, Professor Richard Harvey, “We need to give patients confidence that the treatments being offered by doctors are safe, tested and based on rigorous science.”

The academy’s submission is available here.