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Thursday, December 11, 2008

Stem cell team forges global links

Scientists and regulators are straining to keep up with the rapid progress of stem cell science, writes Leigh Dayton | December 06, 2008
Article from: The Australian

IT'S been a busy week in the lab for stem cell scientist Richard Boyd.

Not only were Boyd and his colleagues beavering away at the bench, they hosted four members of a dozen-strong delegation of biotech and pharmaceutical experts from China, showing the visitors their scientific wares and discussing possible joint ventures.

"We've also had a lot of interest to collaborate from Taiwan, Singapore, Qatar, Dubai and Abu Dhabi," says Boyd, deputy director of Monash University's Monash Immunology Stem Cell Laboratories, or MISCL for short.

It's little wonder that international players are seeking out Boyd and his team. They're ready to take two experimental stem cell therapies -- based on a type of adult stem cells called mesenchymal stem cells -- into the clinic to see if they help people suffering the after-effects of chemotherapy or the ravages of auto-immune diseases such as rheumatoid arthritis.

Just back from a trip to China himself, Boyd is confident the trials will happen soon at centres in Beijing and Harbin. If so, they will be just two of many possible and ongoing international collaborations that promise to turn Australian stem cell research into real-world products and treatments for serious conditions as diverse as diabetes and cardiovascular disease.

Worldwide co-operation is the name of the game at the highest levels of stem cell science, and Australian groups such as Boyd's are major players.

In fact, last June an analysis of the performance of 16 countries engaged in human embryonic (ES) stem cell research was reported in the journal Cell Stem Cell by public policy expert Aaron Levine at the Georgia Institute of Technology in Atlanta. He concluded that Australia was among the top five "over-performing" nations, behind Singapore, China, Israel and the UK. Unlikely as it seems, Levin found that the US was a major under-performer (doi 10.1016/j.stem.2008.05.008).

Such good news may come as a surprise. After all, it's no secret that the hub of Australia's stem cell endeavours -- the Melbourne-based Australian Centre for Stem Cell Research -- has fallen on troubled times. As reported last September in Weekend Health, internal disputes, a scathing independent review of the centre's management and progress, sackings, resignations and "please explains" from Science Minister Kim Carr have left the ultimate fate of the ASCC in limbo.

Right now Carr has received the final report of the 2008 Review of the Australian Stem Cell Centre, which is understood to contain detailed recommendations about the ASCC's destiny. A spokeswoman for the minister says Carr is awaiting advice from his department about public release of the document.

Carr has also asked the centre's interim board and CEO to develop a new modus vivendi and business plan, to be submitted to him next March.

It's not as if the ASCC has closed shop. Stem cell scientist Megan Munsie, ASCC director of government affairs and policy, notes the centre continues to fund and conduct research and is carrying on with educational and international activities.

There is obviously, though, widespread concern within the research community that the centre will not survive beyond 2011 when current funding arrangements end -- if it gets that far. Researchers such as Boyd worry that the pioneering work on policy, ethical guidelines, regulation and national and global leadership, let alone on stem cells themselves, could be tossed out with the ASCC bathwater.

"That's why we don't want to lose the initiative here in Australia," argues Boyd. "All the glory will go elsewhere overseas, not here where we did the hard work."

But for now Carr won't offer any assurances that the ASCC, or any national body, will exist post-2011. Researchers must be content with noises of general support, as this from his spokeswoman: "Stem cell research is at the cutting edge of scientific endeavour, and the Government is firmly behind this fast-moving science. The potential of stem cell science is enormous, both in terms of growing healthy tissue to replace diseased or damaged organs and developing therapies for a wide range of debilitating diseases, including cancer and heart disease."

Meanwhile, as the University of Western Australia's George Yeoh says, "life goes on". Yeoh is an expert in liver diseases and adult liver stem cells, and also associate dean of research at the UWA Faculty of Medicine, Dentistry and Health Science. He agrees the "hiccup" at the ASCC has slowed his group's progress: "It was an infrastructure for the provision of cells (for research), expertise and it ran workshops and meetings." Regardless, Yeoh claims formal and informal networks of stem cell scientists, clinicians and people with allied expertise in areas such as biomedicine, biopharmacy and medical ethics can help plug the gap, at least for now.

A case in point is the brand new Australasian Society for Stem Cell Research. A few years ago Yeoh met up in Melbourne with a handful of colleagues, among them ASCC founding CEO Alan Trounson -- who is now head of the state-funded California Institute of Regenerative medicine in San Francisco -- and Bernie Tuch, director of the Diabetes Transplant Unit at the University of NSW. Their idea was to get something going for groups such as Yeoh's and Tuch's, whose areas do not neatly fit under the ASCC umbrella.

Last year MISCL scientist Susan Hawes -- an expert on how Human ES cells develop into liver cells -- grabbed the reins. The infant society held its first conference and AGM on November 17, during the Australian Health and Medical Research Congress in Brisbane.

Yeoh was elected inaugural president. "We need to fly the flag for stem cell research in Australia," he says, listing a string of goals and jobs to be done working with professional and promotional organisations such as the National Health and Medical Research Council, Research Australia and state-based networks like the NSW Stem Cell Network, headed by Tuch.

According to Tuch, the to-do list focuses on "translational research", readying products and treatments for human trials. That can be as specific as building a central source of home-grown stem cell lines -- from embryonic and adult to the new embryo-free induced pluripotent (iPS) stem cells which ASCC scientist Andrew Laslett and colleague Naoki Nakayama are studying.

At the broader level, Yeoh and Tuch argue for a specialist panel of the NHMRC to look after stem cell grant funding applications, because the field is progressing so rapidly. For example, iPS cells didn't exist a year ago, and progress like that challenges existing review systems.

"Stem cell applications are mixed in with everything else," explains Yeoh.

Similarly, the existing and internationally respected system for regulating stem cell research under federal anti-cloning and embryo research legislation needs tweaking to ensure researchers have a stem cell-specific regulatory framework to move their "translational research" into trials.

Currently the Therapeutic Goods Administration is developing guidelines for so-called Human Cellular and Tissue Therapies. A TGA spokesperson says legislation for the HCT regulatory framework should be ready for introduction to Parliament early next year, with a three-year phase in of implementation to begin in 2010.

Until then, it's catch-as-catch-can for the TGA, research groups and firms like Melbourne-based Mesoblast, which want to trial stem cell therapies -- so far all based on adult stem cells -- with patients. They can adapt existing TGA schemes, lean on guidelines for stem cell trials released this week by the International Society for Stem Cell Research, or team up with overseas centres.

But the push is coming for embryonic cells, and more. There's no need to guess why Richard Boyd's passport is well worn.

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