Self-regulation of autologous cell therapies

To the Editor: Tuch and Wall describe the process by the New South Wales Stem Cell Network in October 2012 of creating a national code of conduct for the self-regulation of autologous cell therapies.1 While Regeneus was an observer at the event, we were not involved in any discussions about industry self-regulation. Subsequently we were approached to participate in a committee to work on various topics, including a self-regulatory framework.

It was clear in the initial teleconferences and discussions with Tuch that the committee, while wishing to establish a code, would not meet Regeneus' views of best practice for the autologous cell therapy industry. In particular, best practice includes:

• generating clinical trial and registry evidence;
• defining the range or extent of conditions being treated;
• ensuring that treatment is delivered in appropriate point-of-care clinical settings; and
• ensuring that the medical specialists in the diagnosis and treatment of the condition are the primary providers of patient care.

Little has changed since 2012, and these key requirements still define our approach, which remains focused on musculoskeletal treatment and the principle that patients should be in the care of relevant specialists. Since early 2013, Regeneus has had no involvement in the committee and played no role in drafting the as yet unfinished self-regulation code.

The article by Tuch and Wall correctly argues that self-regulation can be effective. Interestingly, their in-vitro fertilisation example was driven by fertility specialists.

Our view is that an effective code of practice for autologous cell therapy must require medical treatment by specialist practitioners in the condition being treated, appropriate point-of-care facilities where the treatment is conducted, and independent safety and efficacy outcome measurement of the specific treatment protocol being applied.