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Regulations

Stromal vascular fraction (SVF) was first used as a therapy over 12 years ago in 2004. In Australia, autologous SVF therapy has been used over the past 6 years in medical practice in the treatment of osteoarthritis.

Cell-Innovations have developed proprietary technology which uses ultrasound cavitation to extract the autologous Stromal Vascular Fraction (SVF) with extra-cellular matrix from adipose tissue. Once separated from adipose tissue, the SVF is not manipulated or cultured. A large body of scientific evidence suggests that adipose-derived SVF may act by replacing lost or damaged cells, reducing inflammation, improving the function of cells at the site and recruiting cells from other parts of the body to assist in these processes.

The TGA Guidelines Followed By Cell-Innovations

On May 31, 2011 the new legislative framework for regulation of human cell and tissue products by the Therapeutic Goods Administration (TGA) came into effect (http://www.tga.gov.au/industry/legislation-excluded-goods-order-1101.htm). The Therapeutic goods [Excluded Goods] Order No1 of 2011 (the Excluded Goods Order) allows products that are derived from human tissue and cells during medical procedures that are considered part of medical practice to be excluded from regulation under the new framework. Provided that they are:

  1. Collected from a patient who is under the clinical care and treatment of a medical practitioner registered under a law of a state or an internal territory; and
  2. Manufactured by that medical practitioner, or by a person or persons under the professional supervision of that medical practitioner, for the therapeutic application in the treatment of a single indication and in a single course of treatment of that patient by the same medical practitioner, or by a person or persons under the professional supervision of the same medical practitioner;

Further information can also be found at http://www.tga.gov.au/industry/legislation-excluded-goods-order-1101-guidance-4opqr.htm

AACT

In October, 2012, a number of practitioners, treating patients for musculoskeletal disorders presented their results at the 17th Workshop organised by the NSW Stem Cell Network. There was a panel discussion regarding regulation of autologous therapies in Australia and it was decided to form a steering committee to develop an industry specific voluntary code of conduct to encourage responsible use of the Exclusion order. The Australian Autologous Cell Therapy (AACT) Consortium, with the involvement of approximately ten independent clinical and research member groups was formed. Cell-Innovations is an Executive Member. Four goals were agreed to: practise evidence-based medicine; ensure fully informed consent is obtained; process injected autologous products using internationally accepted standards; and follow the advertising standards set for medical practitioners by AHPRA. Clinicians and companies are encouraged to join and develop responsible self -regulation of the industry. Contact Sarah Walke at sarahwalke@gmail.com

AHPRA

Professional responsibilities of treating medical practitioners

The exclusion from the operation of the Act and Regulations of HCT in the circumstances described in the Item has no effect on the professional obligations of medical practitioners to maintain satisfactory standards of practice that are appropriate to their profession. The treating medical practitioner should be mindful of adherence to professional standards when using products that have not been evaluated for safety and efficacy by the TGA. This would include consideration of whether the treatment being undertaken is necessary and safe and whether its efficacy is supported by credible clinical evidence.

Also, with use of a product that is not approved for use in Australia, patients should be provided with adequate information to enable them to give informed consent to treatment.

Professional standards include professional performance and conduct, which are governed by the Medical Board of Australia. Guidance is contained in Good Medical Practice: A Code of Conduct for Doctors in Australia.

In addition to the Australia Regulatory bodies Cell-Innovations respect the opinions of bodies such as the International Society for Stem Cell Research (ISSCR).

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