Stem Cell Treatments are Regulated

Macquarie Stem Cells are governed by 4 major bodies as listed below;

  1. Code of Conduct for Stem Cell Treatments 
  2. TGA (Therapeutic Goods Association) Guidelines 
  3. The Australian Medical Association (AMA) 
  4. Australian Health Practitioner Regulation Agency (AHPRA)

Code of Conduct for Stem Cell Therapies

  

Dr. Ralph Bright and the team at Macquarie Stem Cells are registered medical and scientific professionals.  We strictly follow the Australian guidelines as indicated by the Therapeutic Goods Association (TGA).

HISTORY OF THE CODE

In 2012, we were called in along with a group of other medical practitioners and research scientists from multiple disciplines, with a common interest in Autologous Cell-Based Interventions (ACBIs), formed the Australian Autologous Cell Therapy consortium. The aim of the consortium was to establish a professional organisation (the Australian Cell Therapy Society – ACTS) and fund the development of a Code of Practice (‘the Code’), to guide members in the safe, ethical, beneficial and timely clinical development and practice of ACBIs, within the existing regulatory framework. 

SCOPE OF THE CODE

The Code will apply to the practice of ACBIs and use of HCT, which meet the requirements of item 4(q) of the Therapeutic (Excluded Goods) Order No.1 of 2011 (the EGO) and therefore are not regulated as therapeutic goods.

Item 4(q) of the EGO only relates to Human Cells and Tissue (HCT) that are:

  • collected from a patient who is under the clinical care and treatment of a registered medical practitioner in Australia, and
  • manufactured by that medical practitioner, or by a person or persons under the professional supervision of that medical practitioner, for 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

The Code does not apply to the use of haematopoietic stem and progenitor cells in accredited clinical settings for treatment of various haematological, immunological and metabolic disorders, which have been established as standard of care.

Any medical practitioner who is a non-member treating patients with innovative ACBIs under item 4(q) of the EGO is also invited to accept and observe this Code as it is considered that the standards to be followed apply to the industry as a whole if it is to maintain the confidence of all stakeholders and meet regulatory requirements and standards for professional conduct.

Whilst all medical practitioners can, and are encouraged to refer directly to laws, codes of conduct and guidelines applicable to their profession, the Code provides a convenient central reference document, which brings all these elements together, as they relate to the use of ACBIs by medical practitioner’s under the EGO) and guides members through the complex regulatory framework within which they practice.


PURPOSE OF THE CODE

  • guide translation of safe and effective therapies to improve patient’s lives
  • highlight the principles of evidence-based medicine as applied to the practice of innovative ACBIs
  • encourage meaningful and ethical clinical research to develop beneficial therapies
  • outline regulatory requirements and professional standards applicable to the practice and advertising of ACBIs
  • highlight the above requirements and provide additional guidance and ethical advice and make these ethical standards transparent
  • outline informed consent processes designed to ensure patients are provided with comprehensive advice allowing them to make fully informed decisions before documenting their consent to undergo an innovative ACBI.
  • Introduce recommendations for the development of an Accreditation Scheme to monitor high quality patient care and laboratory performance according to recognised standards.
  • establish processes for monitoring compliance and independent complaints and adjudication procedures

You can download this 66 page copy of the code here.

 

TGA Regulations

Autologous adipose-stromal vascular faction cell therapy is a refinement of fat transfer that has been used in cosmetic surgery since 1983. Refinement comes as the fat cells are removed leaving the stromal vascular fraction (SVF) cells also known as processed lipoaspirate (PLA).

Once separated from adipose tissue we do not manipulate the SVF cells. They are injected unchanged. We do not culture the cells. We do not use any animal products. A large body of scientific evidence suggests that adipose 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.

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. 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 on the TGA wbsite.

 

AMA & AHPRA Registration

About AMA

Directly stated by the AMA website ” The Australian Medical Association (AMA) is the most influential membership organisation representing registered medical practitioners and medical students of Australia.

The AMA exists to promote and protect the professional interests of doctors and the health care needs of patients and communities.”  (AMA, 2017)

The AMA improves patient care by supporting the medical profession through a range of essential services including:

  • protecting the academic, professional, and economic independence of medical practitioners
  • protecting the wellbeing of medical practitioners
  • promoting and advancing ethical behaviour of the medical profession
  • protecting the integrity and independence of the doctor/patient relationship
  • preserving and protecting the political, legal and industrial interests of medical practitioners

(AMA, 2017)

All medical professionals in Australia have obligations to follow. Dr. Bright has to maintain satisfactory standards of practice that are appropriate to health sector. Dr. Bright is 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.

What does AHPRA do?

Taken directly from the AHPRA website “AHPRA’s operations are governed by the Health Practitioner Regulation National Law, as in force in each state and territory (the National Law), which came into effect on 1 July 2010. This law means that for the first time in Australia, 16 health professions are regulated by nationally consistent legislation under the National Registration and Accreditation Scheme.

AHPRA supports the 15 National Boards that are responsible for regulating the health professions. The primary role of the National Boards is to protect the public and they set standards and policies that all registered health practitioners must meet. Each Board has entered into a health profession agreement with AHPRA which sets out the fees payable by health practitioners, the annual budget of the Board and the services provided by AHPRA. ” (AHPRA 2017)

Please click on the picture below to follow through to the AHPRA website.

AHPRA
What does AHPRA do? Image ref: (AHPRA, 2017)

 

Furthermore, Macquarie Stem Cells 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.

 

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