AUG 30, 2016 08:00 AM PDT

Regulation of Autologous Cell Clinical Interventions

Speakers
  • Director, NSW Stem Cell Network, Australia
    Biography
      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.

    Abstract:
    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.
     

    Show Resources
    You May Also Like
    OCT 02, 2019 11:00 AM PDT
    OCT 02, 2019 11:00 AM PDT
    DATE: October 2, 2019TIME: 11:00am PDT, 2:00pm EDT Ditch the Excel spreadsheets and manage your molecular workflows entirely in your LIMS Achieve configuration of molecular workf...
    AUG 27, 2019 09:00 AM PDT
    C.E. CREDITS
    AUG 27, 2019 09:00 AM PDT
    DATE: August 27, 2019 TIME: 9:00am PDT, 12:00pm EDT Immunotherapies targeting PD-1 or PD-L1 have proven remarkably effective for treating cancer in some patients, with considerabl...
    SEP 05, 2019 04:00 PM CEST
    C.E. CREDITS
    SEP 05, 2019 04:00 PM CEST
    DATE: September 5, 2019TIME: 7:00am PT, 10:00am ET, 4:00pm CEST PCR (Polymerase Chain Reaction) has gone through a massive evolution since its development in 1983. Besides it...
    JAN 23, 2020 09:00 AM PST
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    C.E. CREDITS
    JAN 23, 2020 09:00 AM PST
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    DATE: TIME: adadf adfadf...
    FEB 26, 2020 09:00 AM PST
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    C.E. CREDITS
    FEB 26, 2020 09:00 AM PST
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    DATE: February 26, 2020 TIME: 9:00am PST 3D cell culture and analysis and the study of organoids and spheroids are becoming more prevalent as a research method in publications as traditional...
    FEB 25, 2020 09:00 AM PST
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    C.E. CREDITS
    FEB 25, 2020 09:00 AM PST
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    Learn about how to generate a small scale CAR-T workflow using ThermoFisher products See detailed characterization tools that can be utilized and applied in a CAR-T workflow...
    Loading Comments...
    Show Resources