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Stem Cell Treatments: A quick guide for medical practitioners and FAQ: a resource for patients submission

ID: 
13
This submission reflects the views of
Organisation Name: 
Multiple Sclerosis Research Australia
Personal Details
Questions
1. Is the document in the appropriate format? If not, how could the document be better formatted?: 

The documents are generally well formatted and present the information in a logical and easily to follow order.

The Document ‘Frequently Asked Questions – A Resource for Patients’ Needs a heading as per the medical practioners document. I.e. ‘Stem Cell Treatments – Frequently Asked Questions – A Resource for Patients’.

2. Is the language appropriate for the target audience (i.e. medical practitioner for the quick guide on stem cell treatments and patient for the FAQ resource)?: 

The language and tone of the documents is appropriate for the target audiences.

3. Does the document contain relevant information? If not, which sections do you consider to be irrelevant?: 

All information contained in the documents is relevant and should be retained.

4. Does the document exclude any important information that would be useful to medical practitioners or patients?: 

We see that the documents may inadvertently give false reassurance with regard to a number of "Stem Cell" clinics within Australia. One interpretation is that if a clinic is in Australia (not abroad) then it must be bona-fide. This is not the case, as we are aware of a number of private medical practioners who are providing unproven stem cell treatments. These clinics are, in particular, offering treatments based on autologous ‘stem cells’, frequently derived from adipose tissue. These practices fall outside of TGA regulation, but are not illegal. Practioners are very careful in the wording they use to describe these treatments and therefore also fall outside of the regulations that govern false advertising. None-the-less the treatments offered have not been subject to careful clinical trials to assess their safety and efficacy.

We recommend that the wording of both documents is amended to recommend that an equally cautionary approach is taken by patients when considering stem cell treatments at clinics within Australia.

We also recommend that the documents are amended to draw attention to the fact that the use of autologous stem cells (i.e. cells that are removed and returned to the same patient with minimal ex vivo manipulation) do not come under the jurisdiction of the TGA regulatory framework for cell and tissue based therapies in Australia.

We also recommend that the wording is amended to emphasise the importance of seeking treatments that have only been validated by appropriate clinical trials or are currently being assessed in an approved clinical trial.

In relation to clinical trials, we recommend that the following points are emphasised:

  • · Clinical trials within Australia should have received approval from a Human Research Ethics Committee (HREC)
  • · Clinical trials within Australia or overseas should be listed on a clinical trials register approved by the World Health Organisation such as clinicaltrials.gov or ANZCTR
  • · The trial should be following a clearly defined protocol and the nature of the stem cells and the method used to obtain them should be precisely delineated
  • · The patient should be asked to read and sign a detailed Patient Informed Consent Form
  • · There should be no charge to a patient when they participate in an approved clinical trial
  • · Participating in formal clinical trials means that the patient is contributing to progress towards safe and effective treatments for all people with the same condition as them.

In the Guide for Medical Practitioners, we recommend that question 5 is amended to redefine ‘Stem Cell Tourism’ as including the use of private clinics or private health practioners that fall outside of a person’s usual healthcare team and may indeed include clinics in Australia.

Again the 3rd paragraph of question 5 in the Guide for Medical Practitioners should be amended to incorporate clinics in Australia that are also offering unproven treatments that fall outside of TGA regulation. The Quick Tips section should include the question ‘Is the treatment offered as part of an approved clinical trial?’ (see earlier comments relating to clinical trials).

5. How could this information best be disseminated to patients and medical practitioners?: 

This information is a valuable resource for patients and their medical practitioners. The resource should be widely publicised to medical practitioners via medical journals, both online and print, and via direct mail to general practitioners. Notification should also go out via the RACP and the GP colleges. Disease-specific consumer organisations such as MS Australia and MSRA will readily provide links to these documents via our websites and other print and online resources.

6. How could general practitioners best access this information (i.e. an appropriate website)?: 

The Consumers Health Forum may provide an appropriate location to host this information, as well as the website of the Royal Australian College of General Practitioners

http://www.racgp.org.au/.

Specific Comments
Specific Comments: 
General Comments
Comments: 

Question 7. Are there any other questions or comments you have?

Consideration should perhaps also be given to amending the document for medical practitioners to include a statement advising medical practitioners to consider their responsibilities and potential legal liabilities in relation to their patients’ care. While giving due consideration to a patient’s right to choose, it may be advisable to use an approach that balances respect for a patient’s desire for unproven stem cell treatment with direct advice against an unproven intervention.

 

(Background – Multiple Sclerosis and stem cell research and therapies

Multiple Sclerosis Research Australia (MSRA) is the research arm of MS Australia (MSA) and works closely with the state-based MS client service organisations to represent the interests of people with multiple sclerosis (MS).

MSRA’s mission is to accelerate Australian MS research toward the prevention, better treatments and a cure for MS. We achieve this by working in partnership with relevant medical research institutes and scientists around Australia, encouraging collaborations and focus on our strengths in this research.

In this capacity, MSRA is carefully monitoring international developments in stem cell research for MS and is funding a number of Australian researchers who are working in this field. We have also established the Australian Haematopoetic Stem Cell Transplant Register to monitor the protocols used, and the outcomes achieved, following bone marrow transplants for the indication of MS.

Currently this high-risk, experimental procedure is the only stem cell based treatment that is available to only a very small subset of people with MS through mainstream health-care providers. It is provided only on a case by case basis and very much at the discretion of the treating hospital. To date we are aware of only around 24 people with MS who have received this form of treatment.

Never-the-less there is a high level of interest in stem cell therapies amongst people with MS. We are aware from MSA and its state-based service organisations and through neurologists that some people with MS are visiting clinics both overseas and within Australia, to procure unproven stem cell based treatments.

As such we recognise the great need for reliable resources that assist people with MS and other chronic conditions to make carefully informed choices about their healthcare.

MSRA and MSA are keen to keep people with MS informed of the research progress in the stem cell fields. However we are keen to ensure that this information is presented in a format that keeps people with MS informed without engendering false hope and a false sense of what is currently possible. Care must be taken to convey the significant challenges that must still be overcome before stem cell therapies become part of the standard array of evidence-based therapies for MS.

These documents produced by the NHMRC are a valuable and timely contribution to address this need. MSRA and MSA welcome these documents and have made some suggestions in our responses to the Consultation Questions below.

Of particular note is our concern that the documents do not address the proliferation of clinics within Australia that are currently offering unproven stem cell therapies to people with MS and a wide range of other conditions.)

Page reviewed: 17 February, 2014