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Stem cell treatments are the latest trend in unproven therapies which, experts say, can put patients at risk.
Robyn Wilson, 61, has suffered with chronic pain from osteoarthritis for most of her adult life.
She turned to a new stem cell treatment advertised online by a private clinic in Adelaide.
She was under the impression that the procedure was quick, easy, pain-free and guaranteed to cure her chronic pain.
“I don’t think I was properly anaesthetised,” she said.
“Not only am I out of pocket $9000, but I’ve had multiple complications from the procedure… swelling, stiffness in all my joints, I can barely move on a good day.”
In some cases, you might not even be receiving stem cells at all - Dr Rasko
Commercial promotion of unsupported therapeutic use of stem cells is a global problem that has proven resistant to regulatory efforts, according to experts.
Direct-to-consumer marketing of unproven stem cell treatments - typically of cells obtained using liposuction methods - places the health of individuals at risk, according to Dr John Rasko.
Dr Rasko is a clinical hematologist, pathologist, and scientist at the Royal Prince Alfred Hospital in Sydney and said there was a strong drive for people to seek these forms of therapy.
“It worries me enormously that a number of people have taken themselves overseas, in particular, the clinics in Russia, where this has been widely advertised on the internet.
“In some cases, you might not even be receiving stem cells at all.”
These treatments are increasingly popular in Australia which has the highest per capita rate of clinics offering such treatments online, according to a recent study by Dr Rasko called Global distribution of Businesses Marketing Stem-Cell based Interventions.
This is due to the regulatory loopholes that allow clinics to carry out treatments because patients are injected with stem cells from their own fat deposits.
“I’ve thought about taking action against them, but the energy and mental stamina it will take for what will likely be zero benefit, is just too much for me,” Ms. Wilson said.
“I hope that people can learn from my mistake and do their research before they look to these treatments,” she said.
The process of approved stem cell treatment in hospitals is invasive and physically exhausting.
It is used to treat a number of conditions such as osteoarthritis, multiple sclerosis and various forms of cancers.
There are many therapies available, but the most common approved treatments involve a series of stem cell transplants and transfusions from a donor - typically from bone marrow.
People receive ... treatments in the hope that their ailments will be cured with no guarantees as to its safety or efficacy - Dr Rasko
In his research, Dr Rasko found that 5% of multiple sclerosis sufferers who received stem cell treatment in an unregulated market within Australia or overseas have died.
“It’s in the greyest of the grey zones between proven and unproven,” Dr Rasko said.
“It’s an emerging technology in the case of multiple sclerosis where there is some evidence in favour of it [stem cells]... but the balance between the toxicity versus the benefit is currently under debate and exploration.”
Patients with serious diseases or conditions for which there are no comparable satisfactory therapy options outside of clinical trials, can gain access to unproven treatments.
People receive investigational treatments in the hope that their ailments will be cured with no guarantees as to its safety or efficacy.
Dr Wendy Lipworth, bioethicist, and health social scientist at the University of Sydney said for many people, it is their last resort.
“People who are in very vulnerable and desperate situations who have no other options are given the impression that there are effective therapies when in fact, there is no such thing.
“The danger comes in when we move too far in the direction of, well, this could potentially, theoretically work, so let’s start charging people huge amounts of money to do it and let’s advertise it and portray it as if it’s an established therapy,” she said.
Her colleague, Professor Ian Kerridge, internationally recognised scholar in the philosophy of medicine agrees.
“Because there’s a degree of uncertainty, there’s interesting scientific questions, there’s interesting clinical questions, and people are alert to all of the uncertainty, that’s fine,” he said.
“But when somebody knows that there’s going to be a consequence of something and exploits somebody’s vulnerabilities to make a profit for themselves at substantial cost or risk to that person, that sounds pretty ugly to me.”
Dozens of scientists and prominent research bodies have been charged for scientific fraud by falsely claiming medical breakthroughs using stem science.
Rather than producing independently verified proof of results, these scientists rely on substantiated claims of ‘improvement’ or eradication of patients’ symptoms or disease.
Informed consent is overlooked and patients are risking their health and financial security.
Dr Lipworth said there is a fine line between innovation and best practice.
“We do want to encourage doctors to innovate, but there is a balance to be struck between trying new things on the one hand and first finding out whether the interventions are actually therapeutic on the other,” she said.
The “right to try” and the ability for people to make informed decisions is influencing current markets.
People argue that it is a private matter that should not involve government or other regulatory bodies as it is their own body and they can do what they like with it.
However, Prof Kerridge said while this may be true, there needs to be stronger regulatory measures to ensure people are seeking approved and safe therapies.
“Governments intervene with all the goods we have access to,” he said.
“You can’t just rely on the manufacturers and the servers of products to determine what is adequately safe and effective, so why should this be any different?”
Results of the stem cell anti-ageing treatment offered by Boho Travels (Image/Boho Travels)
Clinics around the world are using regulatory gaps to sell “stem cell treatments”.
Jitka Hrebikova from Boho Travels in the Czech Republic - a tour operator that focuses on medical tourism - is launching a new stem cell treatment for anti-ageing.
She said Boho Travels works closely with Czech scientists who are specialists in regenerative medicine to provide high-end medical services using autologous stem cells.
“The anti-aging is our new product and is obtained from one’s own bio-material… but I have personal experiences because I have asked my lovely mother to test it before I have started to offer this to our clients,” Ms. Hrebikova said.
“My mother looks great, skin became rejuvenated, wrinkles became smoother and the look is in general very natural.”
There are number of current legislative and regulatory controls in practice in Australia.
Many of these are through the Therapeutic Goods Association, medical boards such as the Australians Health Practitioners Regulation Agency (AHPRA), as well as the Australian Competition and Consumer Commission.
“But those agencies need to be able to act, they need to have the power to, they need to have the resources to, and essentially, they need to have the courage to,” Prof Kerridge said.