NSW Stem Cell Network on self regulation of Autologous Cell Therapies in Australia towards innovative treatments and patient care
As a result of the 17th Workshop of the NSW Stem Cell Network, 'Cellular Therapies for Repair of Musculoskeletal Injuries', a steering committee was formed to drive development of a self regulation code of conduct for 'unproven' autologous cell therapies in Australia. Prof. Bernie Tuch presented the following poster at the International Society for Stem Cell Research meeting in Boston 2013 and also gave an oral presentation on this process the 2013 Australasian Society for Stem Cell Research meeting.
When will patients benefit from stem cell therapy in Australia? - The challenges of taking stem cells from the lab to the clinic
SYDNEY, AUSTRALIA, Tuesday 26 November 2013 – Australian stem cell experts are joining forces to address the future of stem cell research in Australia and the critical gap in taking innovative stem cell therapies from the laboratory to patients in the clinic.
Over 100 clinicians, scientists, policy makers, investors, IP lawyers, patient advocates, pharma and biotech executives are participating in the Workshop - Innovating the Marketplace with Stem Cells - hosted by the NSW Stem Cell Network to take a serious look at this vital issue facing Australia’s stem cell industry.
Professor Bernie Tuch, Founder and Director of the NSW Stem Cell Network said that Australia is the birth place of innovative ideas in stem cell research and therapies and has demonstrated commercial success as the birthplace of the world’s biggest stem cell company, Mesoblast (ASX:MSB) and Genea Biocells, world leading supplier of application-ready differentiated disease specific stem cells. Clinically we also have some of the most innovative research including success in clinical trials for stem cell treatment of a corneal eye disease at University of NSW and for treatment resistant Crohn’s disease at the University of Western Australia.
In light of these successes, the Australian industry is plagued by a loss of our IP, talent and manufacture to countries abroad, that are better supported with commercialisation and investment opportunities.
‘A collective effort is needed to push this industry forward. Basic researchers need to become educated as to the part they play in getting their technology to patients and interactions need to improve between Australia’s researchers, clinicians, commercial and regulatory bodies towards driving realistic solutions.’
‘The US, Switzerland, Germany, the UK, many countries are currently running clinical trials for which we have the expertise in Australia, many even utilise Australian technologies. We cannot miss the chance to lead this industry by sitting back and waiting’, said Professor Tuch.
Key-note speaker, Professor Igor Slukvin, University Wisconsin-Madison will be presenting a new stem cell technology, CymerusTM, which has the potential to manufacture billions of human Mesenchymal stem cells from a single embryonic stem cell and poses great therapeutic potential for patients.
Dr Slukvin invented his technology in Wisconsin laboratory alongside Professor James Thomson, who is well-known for creating the world’s first embryonic stem (ES) cell line in 1998 and human induced pluripotent stem cells in 2007.
“Stem cell therapy has not taken the path that scientists predicted over ten years ago. We have found one type of stem cell, The Mesenchymal stem cell, that shows great promise and is ready for clinical trial for a broad range of diseases right now,” says Dr Slukvin.
Mesenchymal stem cells works by stimulating the body’s own healing systems giving the potential to remedy a broad range of diseases including cardiovascular disease, diabetes, diseases of the blood, lung, kidney, eyes teeth and immune system diseases.
Dr Paul Brock who has Motor Neurone Disease and is a long time advocate of stem cell technologies in Australia says, “I have been disappointed at what has appeared to me to have been the slow take up of Australian research projects utilising the legislative green light given to stem cell research in Australia.”
However he is ‘confident that effectively resourced, internationally collaborative stem cell research, thriving within a multidisciplinary cross-siloed scientific approach to ultimately producing successful therapeutic outcomes, will play a vital role in better understanding the causes of and eventually developing cures for currently incurable, terminal neurological diseases such as Motor Neurone Disease’
Recent activity in Australian stem cell research and industry indicates that if properly supported Australian’s could be the first to benefit from clinical stem cell trials.For media enquiries contact Daniella: 0416 211 067
Early Mid Career Researcher Network NSW born to strengthen academic/industry ties
The Science Pathways 2013: Engaging with Industry meeting was run by the EMCR forum in Melbourne the 17th and 18th of October. The meeting focussed on the difficult environment into which PhDs are finding themselves, with only one in 10 likely to receive full time academic employment, and consequently how they must be informed and proactive in driving their career opportunities through developing industry contacts.
The meeting began with an address from Australian Chief Scientist Prof. Ian Chubb who stated the flaws in the all too common ‘we just need more money’ argument. He described how Australian government funding for research has only ever increased and how we should spend less time moaning about money and the titles of ministers and more time making well structured strategies for a technology based future that addresses key issues in society. Australia has some of the strongest basic research and advanced manufacture in the world though our technologies are being sold off internationally due to the lack of intimate interaction between researchers and commercial bodies that nurtures security in innovations. While competing advanced manufacturers like Germany have 80% of their PhD’s in industry R and D, Australia has only 30%, reflecting the weakness of our Academic/Industry relations.
With representation from IBM Australia, CSL and the Medical Research Commercialisation Fund there was a lot of discussion about attitudes. The attitude that commercialisation is evil and research should be undirected has lead to a generation where tax payer money is being used for research that due to lack of industry contacts is never translated and thus never benefits society. "
The meeting concluded with the generation of solutions at the national, institutional and individual level, for the latter including researchers taking the risks to become more proactive about realising the market in which their career exists and taking initiative to put aside misconceptions and make industry contacts for mutual benefit. Interestingly a great importance was put towards PhD training that does not narrow students into academic thinking, where only one in ten are likely to receive long term employment. "
The EMCR Network NSW has been founded by Dr Heather Main to support researchers in understanding the climate into which their careers are moving and providing support and networking events to aid their progress. Regular meetings will ensure interactions with Australian R and D companies towards improved academic/industry relationships, driving innovations, Australian R and D and manufacture. Free membership is available to all interested in assisting the career development of our budding scientific innovators. "To register as a member and to hear about upcoming events please contact
NSW Stem Cell Network hosted forum attracts media attention warning against unproven stem cell treatments
An expert panel of scientists and clinicians adressed over 250 members of the public at the recent forum at the Cerebral Palsy Alliance, Allambie Heights, Sydney. The event was live streamed to an international audience warned people against going overseas for costly and unproven stem cell treatments for cerebral palsy.
The Cerebral Palsy Alliance estimates as many as 500 Australians have sought stem cell therapies overseas often spending up to $40,000 on unproven treatments.
"A lot of these stem cell tourism companies don't even describe what type of cells they're giving, so first we don't even know if they're human cells... so, of course, it is a very risky procedure. "There has been a couple of cases internationally of children actually dying from these treatments."ABC Report (from Tanya Nolan) regarding the recent Sydney Based forum (http://www.abc.net.au/news/2013-05-22/warning-against-going-overseas-for-cerebral-palsy-treatment/4706408
The Network recommended that there be:
1. No change to the existing legislation regarding the use of human embryonic stem cells for medical research, including the creation of cell lines by somatic cell nuclear transfer (also called therapeutic cloning).
2. Improved communication between the NHMRC Licensing Committee and the Human Research Ethics Committees involved in applications from researchers seeking licences for creation of stem cell lines. This change in operative arrangements should ensure there is only one set of instructions given to researchers for their application to be considered.
3. No change to the existing legislation regarding the banning of reproductive cloning.
To read the complete submission click here
Stem Cells Used to Treat Children With Life-Threatening, Blistering Skin Disease
Science Daily http://www.sciencedaily.com - 12/08/2010
Scientists from the University of Minnesota have been able to treat children with Recessive Dystrophic Epidermolysis Bullosa (RDEB) using bone marrow stem cells. Science Daily reports on the results which have been published in the New England Journal of Medicine.
Stem-cell therapy to begin on humans
Sydney Morning Herald http://www.smh.com.au/ - 01/08/2010
US Company, Geron, has received approval by the FDA for human clinical trials of its new GRNOPC1 therapy. This embryonic stem cell therapy aims to treat spinal cord injuries.
Stem cell therapy 'first' in trial on arthritic knees
Bristish Broadcasting Corporation http://www.bbc.co.uk/ - 13/07/2010
A trial by Arthristis Research UK aims to use stem cells to repair damage in those suffering from osteoarthritis.
Patients Beware: Commercialized Stem Cell Treatments on the Web
Cell Stem Cell http://www.cell.com - 17/06/2010
Prompted by concerns of "miracle cures" and medical tourism, the International Society for Stem Cell Research (ISSCR) has recently developed a task force to assist potential patients and their doctors in assessing merits of stem cell therapies offered by different organisations.
You can also connect directly to the ISSCR's task force by visiting their website: http://www.closerlookatstemcells.org
The Network's Response to the TGA Discussion Paper on the Regulation of Autologous Stem Cell Therapies
The Network recommended:
1. AHPRA be requested to review the advertising being carried out by clinics promoting autologous cell treatments, and officials from this organization be asked to guide those who are deemed to be in breach of the regulations to improve. Repeated offenders should be prosecuted.
2. Support the establishment of a self-regulated Code of Conduct, and suggest that it also include mandatory reporting of Adverse Events.
3. Monitor the outcome of the Code of Conduct on an annual basis.
4. Educate health and medical practitioners about stem cells and their uses.
5. Educate the general public about stem cells and their uses.
6. The TGA make no change to the current regulations (Option 1), which excludes autologous stem cell therapies from regulation as therapeutic goods, and is akin to how bone marrow transplants are regulated in Australia.
7. Review of progress in the field occur in 3 years (January 2018), with a view to determining if there should be a recommendation to COAG to tighten the rules and no longer exclude stem cell therapies from regulation as therapeutic goods.To view the TGA Consultation Report, click here For The Network's response click here
The 19th NSW Stem Cell Network Workshop hailed as the best yet and drives steps towards addressing stem cell research translation
'Innovating the Marketplace with Stem Cells' attracted 131 registrants from 76 organisations representing sectors as diverse as, commercial and academic research/management, investors, policy makers, lawyers, patent attorneys, venture capitalists, regulators, clinicians, GPs and cell therapy providers. Integration of these sectors is crucial to bringing stem cell therapies to patients.
Twenty one speakers described the progress of stem cell research and innovation in Australia and on a global perspective, outlining the issues faced by the Australian Industry and the cooperative nature of strategies required for successful delivery of stem cell therapies to patients. Breakout sessions, cabaret style cross disciplinary allocated seating, an open floor panel session and informal end of day refreshments encouraged communication and collaboration towards solutions for commercial, educational and regulatory restrictions facing the stem cell industry. The full program and abstract booklet can be downloaded from our 'past events' workshops list.
Based on presentations and discussions on the day a report of calls to action towards building the Australian stem cell industry and reducing the barriers towards getting innovative treatments to patients has been developed and can be accessed below. Development of infrastructure, relationships, collaborations, knowledge exchange and a novel business model which addresses both commerical and compassionate grounds was identified as crucial to the success of the industry, which is measured in patient benefit.
As a result of the workshop a committee is being formed to submit a proposal for funding to set up an alpha stem cell clinic in NSW and efforts are being made to build infrastructure for better communication and collaboration between stem cell researchers and clinicians.
The NSW Stem Cell Networks thanks everyone involved in this project thus far and looks forward to working with you in the future to ensure results.For the full PDF report click here
NSW Stem Cell Network hosts schools screening of Stem Cell Revolutions
On the 30th of October the NSW Stem Cell Network hosted a schools screening of the film Stem Cell Revolutions at the Museum of Contemporary Art. With 4 Sydney schools registered, 60 students attended the film screening, followed by a lively discussion between students and scientists about stem cells and scientific careers.
This award-winning film, produced by Amy Hardie and Clare Blackburn from EuroStemCell, previously won Best Documentary at the Vedera la Scienze festival 2012. The film relates the history of stem cell science as told through the eyes of leading international scientists. It tracks the discovery of stem cells and evolution of the field, through to modern day personalised medicine applications. In a world where technology moves so quickly and promises of miracle cures tempt the vulnerable, the film takes the viewer on the journey of the very scientists who have made major discoveries in stem cell research, together with the repercussions arising from the application and regulation of these technologies.
The film screening was followed by a question and answer discussion which gave the opportunity for students to ask anything they had ever wanted to know about stem cells and where they stand in Australia and the world. The distinguished panel represented a comprehensive range of Sydney research institutes and major Australian stem cell institutions, and consisted of Dr Michael Morris (University of Sydney, ASSCR Secretary, and NSW Stem Cell Network), Dr Nick Di Girolamo (University of NSW), Dr Uli Schmidt (Genea Biocells), Dr Alexis Bosman (Victor Chang Cardiac Institute and Stem Cells Australia) and Dr Clare Blackburn (University of Edinburgh and EuroStemCell). The questions were many and varied, and created a stimulating personal and scientific discussion between the panel and students with a sci fi twist of the future possibilities of stem cells.
The hot topics of discussion included the ability to grow organs in the lab, clone organs from dead people, clone people from dead people. Would these organs retain the memories/experiences of the person from which cells were taken, could we clone dinosaurs? The students were fascinated by the possibilities of stem cells and the idea that they could one day be sitting on the panel as the future researchers of Australia. The event provided a useful platform for transmission of information for students including what is possible, what ethical and technical problems are associated with stem cell technologies. It is only with good communication between the scientists and our up and coming minds that we can all reap the maximum benefits of research, and events like this provide an example of how to promote this communication.
The event illustrates the success of collaboration between Australia's major stem cell entities, the NSW Stem Cell Network, Stem Cells Australia and the National Stem Cell Foundation. As a follow up from the 9th December 2012 public screening event, this screening continues strengthening Australia's interaction with the European stem cell body EuroStemCell. The NSW Stem Cell Network is continuing its association with the Museum of Contemporary Art towards developing further science/art promotions. We would also like to thank the Scottish Documentary Institute for permission to screen the film.
More information on stem cell research and stem cell tourism is available from the Stem Cells Australia or Australasian Society for Stem Cell Research websites. EuroStemCell also has a lot of accessible information and resources on stem cell research and regenerative medicine, for teachers, patients and other non-specialist audiences - including more films!Anyone interested in hosting a screening of the film in Australia should contact
NSW Stem Cell Network hosted diabetes forum is a packed house!
It was a packed house at our free forum earlier this week at which people heard from leading scientists and clinicians about the latest developments using stem cells to combat type 1 diabetes.
Australian Diabetes Council members and other interested observers listened to presentations from Professor Bernie Tuch (NSW Stem Cell Network and CSIRO), Associate Professor Maria Craig (Children’s Hospital, Westmead) and Professor Allan Robins (ViaCyte Inc, USA) about different approaches to the issue, including an implant made from stem cells that would allow the production of insulin within the body, and a new study to investigate how to prevent or delay the onset of type 1 diabetes in high-risk children using cord blood.
Since 2009, ADC has supported the NSW Stem Cell Network, a wonderful organisation with over 450 members dedicated to building public knowledge and awareness of the role which both adult and embryonic stem cells may play in dealing with the diabetes epidemic."See the whole story at http://www.australiandiabetescouncil.com/media/news/report-diabetes-and-stem-cells-seminar
Stem-Cell Scientists Win Nobel Prize in Medicine
We salute two of our colleagues, Professors John Gurdon of the U.K. and Shinya Yamanaka of Japan, who share this year's Nobel Prize in Physiology or Medicine for their work in so-called cellular reprogramming.
In the 1950’s Professor Gurdon cloned a frog by replacing the DNA from a frog egg with that from a tadpole. Half a century later, Professor Yamanaka showed it was possible to de-differentiate skin and other cells into pluripotent stem cells, by introducing a cocktail of pluripotent genes. These cells are called induced pluripotent stem cells, and have similar properties to those that are found in pluripotent stem cells derived from embryos.
The innovative studies of these two distinguished scientists highlight the wonderful world of stem cells, and the ever present need to think laterally, and to challenge existing paradigms.ABC Report (from Leigh Dayton) regarding the recent Nobel Prize announcement (http://mpegmedia.abc.net.au/rn/podcast
Eye Grown from Stem Cells
The Scientist http://www.the-scientist.com/ - 06/04/2011
With the proper culture conditions, mouse embryonic stem (ES) cells can spontaneously form the rudiments of a retina -- the neural tissue and most complex component of the eye
ISSCR announces task torce on unproven stem cell therapies
An invaluable resource for patients and clinicians. Read the report here to find out more about its purpose, or visit the website to use this service
Stem cells, obesity finding lead Nobel Predictions
Reuters http://www.reuters.com - 21/09/2010
Amongst those predicted to win Nobels this year are researchers from the Ontario Cancer Institute for the discovery of stem cells in bone marrow, and Shinya Yamanaka for the discovery of how to create iPSCs from skin cells.
US stem cell researchers get temporary stay on funding ban
Australian Life Scientist http://www.lifescientist.com.au - 13/09/2010
The injunction placed on federally funded ESC research by a District Court Judge has been suspended to give both sides time to prepare arguments for a September 20 deadline.
First child stem cell trachea transplant a success
Life Scientist http://www.lifescientist.com.au/ - 10/08/2010
Ciaran Finn-Lynch is the first child to have successfully undergone a trachea transplant using his own stem cells to reduce the risk of rejection.
Mesoblast advancing towards Phase III trials hope
Life Scientist Australia http://www.lifescientist.com.au/ - 14/07/2010
Melbourne-based company, Mesoblast, is on its way to FDA approval for phase 3 clinical trials. Mesoblast works with adult stem cells, and this new therapy is targeted at improving the success of bone marrow transplants.
Stem Cell News
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