According to this article, Australia allows autologous stem cell treatments. So where is KT Lim and where is Cytori in this country? WTF?
The national drugs regulator has been urged to clamp down on an increasing number of clinics charging desperate patients thousands of dollars for experimental stem cell treatments.
Leading medical and research organisations have backed stringent restrictions proposed to close a legal loophole that allows doctors to offer the unproven autologous stem cell therapies, where the patient's own cells are used. Because of this, the treatment is unregulated by the Therapeutics Goods Administration.
Patients searching for cures to life-threatening and debilitating conditions were at risk of paying huge medical bills to become research subjects without the safeguards of a regulated clinical trial, according to the Medical Council of NSW and the National Health and Medical Research Council.
But clinics providing autologous stem cell treatments have opposed the proposed crackdown and asked the TGA to let the burgeoning industry police itself.
Reports of a growing number of doctors charging up to $10,000 for unproven autologous stem cell therapies last year prompted the TGA to launch a public consultation to address Australia's lax regulations of the growing practice.
Clinics marketed the unproven therapies as treatments for conditions ranging from joint pain and anti-ageing makeovers to cancer, paraplegia and autism in children.
Currently autologous stem cell treatments administered by doctors are not regulated by the TGA because the stem cells are extracted from the patient's own body and don't qualify as therapeutic goods.
"Under the current system there is no requirement for monitoring or reporting adverse events. We're completely in the dark whether these treatments have the potential to do harm or any good," said Martin Pera at Stem Cells Australia, a consortium of stem cell researchers
In its submission to the TGA's consultation, Stem Cells Australia warned that Australia risked become a stem cell tourism destination for overseas patients and companies seeking to take advantage of the lack of oversight.
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"Compared to many jurisdictions internationally our rules are very lax and of course that will act as an invitation to particular unscrupulous operators who are in the business of making money," Dr Pera said.
"We want to see legitimate stem cell therapies tested in humans and succeed, there is no doubt about that, but there are proper channels to do that," he said.
The Medical Council of NSW and the NHMRC have backed the strongest possible regulations proposed by the TGA, including restricting patient access to autologous stem cell therapies, compulsory reporting of adverse events and a ban on advertising to the public.
"There may be significant potential and possibly as yet unidentified risks to patients in an unregulated environment," the Medical Council of NSW wrote in its submission to the TGA.
The NHMRC has also urged doctors to report fellow medical professionals over concerns that they were offering patients autologous stem cell treatments.
But clinics currently providing the treatments have opposed any move to tighten regulations under the TGA.
The Australian Cell Therapy Society (ACTS) – a group of Australian doctors and stakeholders providing the therapies – have created a code of conduct that they hope will become the blueprint for the industry to police itself.
The NSW Stem Cell Network have backed the code of conduct, saying "it is important not to stifle innovation by putting beyond the reach of those wishing to be inventive".
The NSW Stem Cell Network said that while was not aware of any published studies that demonstrated the effectiveness of the treatment in humans, "we are aware of a number of sports stars that appear to have benefited from receiving such cell applications," its submission read.
The story Unregulated stem cell therapy: TGA urged to crack down on autologous treatments first appeared on The Sydney Morning Herald.
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Australia allows autologous stem cell treatments. So where is KT Lim and where is Cytori in this country?
Good question- but similar questions can be raised for the EU and various other countries, primarily in Asia...
This announcement from July 2013 for instance :
“Celution® System approval and claims in Singapore complements our existing Asia-Pacific approvals by strengthening market access in the region and reinforcing our global regulatory strategy. We anticipate seeing a relevant impact on sales in 2014 as a result of the approval in Singapore, combined with recent approvals and registrations in Australia, New Zealand and in Japan,” said Seijiro Shirahama , President of Asia-Pacific for Cytori. “We will continue to pursue new regulatory approvals in large markets and strategic countries in Asia as well as continue to expand existing claims for the Celution® System in the more than 40 countries where we already have approval.”
Asia-Pacific has been and continues to be a key region for Cytori, supported by a growing number of regulatory approvals and patents issued. In 2007 and 2008, Cytori received patents in Singapore covering the Celution® System and for vascular conditions relating to the use of ADRCs to restore blood flow.
Singapore represents a major medical market and is a leader in medical innovation and research, being ranked fourth in global healthcare infrastructure in the IMD World Competitiveness Yearbook in 2010. Singapore has committed more than $12 billion in continued support of research, innovation and enterprise activities between 2011 and 2015, $2.9 billion of which is dedicated to the biomedical space.
Maybe they are all waiting for CTX-2 to start moving????
Who knows- and if you ask you probably will not get an answer - as always.
Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology.
Australia Opportunity Goes Nowhere with Cytori?
10 May 2015 10:01 #4462
Life is good for them, a decade of BS cycle of Partner, approval, trials, partner... they made a good life, what do they care? there is always a bozo waiting to buy it on a dip to "make money"... So Marc is justified, no?!
Anyway, there is only a fraction of a percent chance of this company making it... accept it, and life will be much better.