Autologous cell therapies are being practised by an increasing number of clinicians for the treatment of rheumatological conditions, sports injuries and other disorders. The source of cells is mostly the vascular stromal fraction from lipoaspirates, and platelet rich plasma. Oversight by the Therapeutic Goods Administration (TGA) is not required because of a broad exemption permitting clinicians to treat their patients with autologous cells without restrictions on the extent of manipulation or whether the cells are used in a homologous manner.
Because of this lack of oversight, there is concern about safety, efficacy, ethics, and advertising. To address these concerns, the NSW Stem Cell Network held a Workshop in Sydney during October 2012. Four key companies practising autologous therapies for rheumatological conditions presented their data, as did Mesoblast, which is conducting allogeneic clinical trials. A representative of the TGA spoke about the regulatory requirements, and cell manufacturing requirements were addressed by the regional branch of the International Society for Cellular Therapy.
After the workshop a Steering Committee was created to discuss self regulation by those practising autologous therapies. The Committee met on 6 occasions, and its autologous members agreed to create a Written Code of Conduct (Code). This will include (a) the need for the development of evidence based medicine; (b) ensuring fully informed consent is obtained; (c) following international manufacturing standards; and (d) using advertising standards set by Australian Health Practitioner Regulation Agency. The input of regulatory bodies, stem cell organizations and end users also will be sought.
The Code is being funded by companies using autologous cells. It is argued by some that self regulation will not be possible because of the financial interest of the organizations involved. Further, many using autologous cells are not currently following all aspects of what will appear in the Code. Yet, there are good examples of self regulation working in both the Australian pharmaceutical industry and with clinics practising in vitro fertilization. In summary, we are cautiously hopeful that the Code will be beneficial, especially in the absence of external regulatory oversight.