AUG 30, 2016 08:00 AM PDT

Regulation of Autologous Cell Clinical Interventions

  • Director, NSW Stem Cell Network, Australia
      Dr. Bernie Tuch is Director of the NSW Stem Cell Network and a Professor of Medicine at both The University of Sydney and Monash Universities. He is involved in cutting-edge research with clinical applications, looking at novel ways of achieving positive outcomes. Attempts to examine the safety and efficacy of novel interventions have been through phase 1b/2a clinical trials, including the use of human fetal pancreas, and more recently encapsulated human islets, as a therapy for type 1 diabetes. His former research group was responsible for the creation of the first human embryonic stem cell lines at an Australian public hospital. Over the past few years he and his colleagues have grappled with the issue of trying to move the stem cell field forwards expeditiously in humans with interventions, many of which are unproven.

    Autologous cell based interventions, which include mesenchymal stem cells, are mostly unproven therapies increasingly being applied for musculoskeletal and other medical disorders by medical practitioners, with limited regulatory control. A self-regulated Code of Practice written for such Australian practitioners was released in February 2015. It required external review of the medical practices amongst other checks and balances that included (a) practising evidence based medicine; (b) ensuring fully informed consent was obtained from patients; (c) manufacturing the autologous product to be injected into the patient using internationally accepted standards; and (d) following the advertising standards set for medical practitioners by the Australian Health Practitioner Regulation Agency (AHPRA). Whilst the Code of Practice is beginning to be followed by some, with clinical trials approved by a Human Research Ethics Committee, and a Register of Adverse Events created, it may be too little too late. In July 2016, the NSW Coroner released findings of a case whereby an elderly person given autologous stromal cells derived from lipoaspirate to try and assist progressive dementia died within 24 hours of the procedure. This appears to be the first recorded death in Australia of a recipient of an autologous (stem) cell intervention.

    In September, the Therapeutic Goods Administration released a Consultation paper inviting feedback on proposed tightening of the regulations. These include no direct marketing to the public, upgrading of manufacturing standards, registering with the TGA, and reporting of serious adverse events. If the regulations are indeed tightened, as now seems likely, the number of unproven autologous cell based interventions should diminish, as will the risk to recipients. However, at the same time innovation is likely to be reduced, as the cost for carrying out the interventions increases to meet the new standards required.

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