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Whatsapp Liposuction is performed on a patient before a stem cell treatment.

An inquest finds a cosmetic surgeon's performance led to the death of 75-year-old woman with Alzheimer's, amid calls to tighten the medical regulations that cover stem cell treatment. Ann Arnold reports.

The NSW deputy coroner has found that a 75-year-old woman, Sheila Drysdale, died from uncontrolled blood loss caused by a mini-liposuction stem cell procedure. It is understood to be the first reported death as a result of this experimental procedure.

There is no clear evidence of benefit, And there is clear evidence of risk.

In scathing comments delivered this morning, the coroner, Hugh Dillon, said the treatment, given to Mrs Drysdale in December 2013 for her Alzheimer's disease, 'has some of the troubling hallmarks of "quack" medicine: desperate patients, pseudo-science and large amounts of money being charged for unproven therapies'.

Dr Bright has stated that he had a conversation with Sheila's husband four days prior to the procedure, and told him that Sheila should stop taking aspirin.

But the coroner found that at Macquarie Stem Cells on the day of the procedure 'there was a failure to check that the blood-thinners had been stopped'..

Dr Bright, a cosmetic surgeon, is one of the pioneers of the fat-derived stem cell industry in Australia. The coroner said: 'Dr Bright’s performance as a medical practitioner was ... poor and resulted in Sheila Drysdale's death.'

He recommended that Dr Bright be investigated by the NSW Health Care Complaints Commission.

Other doctors continue to use stem cell therapies to treat everything from diabetes to multiple sclerosis, even when there is negligible evidence for its effectiveness.

There is anecdotal evidence of success for some patients. But there are risks. Background Briefing has learnt of previously unreported incidences of harm.

Only a few months after Sheila Drysdale's death in Sydney, a woman called Mary went to the same clinic, Dr Bright's Macquarie Stem Cells, to treat her rheumatoid arthritis, in April 2014.

Mary, who is from Perth, had been suffering chronic pain from the disease for 25 years.

She said the liposuction was even more painful than the disease. It wasn't Dr Bright who did the lipo, and she believes she was not properly anaesthetised. Dr Bright later the same day intravenously injected some of Mary's cells that had been extracted.

There is currently no strong evidence that this fat-derived stem cell therapy can treat this complex form of arthritis.

Do you know more about this story? Contact Background Briefing.

Mary says she spent about $17,000 on the treatment, which included a second injection, and the travel. But that's not all.

'The effect of having this stem cell therapy was extremely detrimental to Mary's health,' says her rheumatologist, Dr Patrick Hanrahan, 'predominantly because as part of the procedure she was obliged to stop the conventional medication I'd been giving her.

'Her disease went generally right out of control. She had wide spread swelling, pain, stiffness [in] her hands, wrists, shoulders, feet. Every joint in her body seemed to flare up and she went backwards considerably.'

Dr Hanrahan says this setback has likely caused permanent damage to Mary's joints that would not have occurred otherwise.

Background Briefing put questions to Dr Ralph Bright about this case, and asked him about Sheila Drysdale's treatment, but he did not respond.

Dr Ralph Bright did not give evidence at the inquest.

The coroner in Sheila Drysdale's case said there needed to be 'legal protection against the exploitation of severely and chronically ill people by purveyors of scientifically dubious therapies'.

He said innovative or experimental medical practices should only be conducted within 'strict, reviewable, scientifically recognised clinical protocols'.

Critics demand more regulation

Bioethicist Professor Ian Kerridge and other critics are asking why it is that complex diseases continue to be treated by an unproven procedure—and why the Therapeutic Goods Administration (TGA) hasn't yet taken decisive action.

'I think this is operating in the grey zone that exists between innovation, practice and research,' Professor Kerridge says.

'Sometimes patients, particularly vulnerable patients, can be preyed upon. And my concern is that's exactly what's happening.'

Dr Hanrahan argues that this kind of stem cell therapy should not be legal in Australia until studies are carried out assessing its efficacy and safety.

'There is no clear evidence of benefit,' he says. 'And there is clear evidence of risk.'

Doctors who work with fat-derived stem cells are exploiting a loophole in regulations. Because the injections consist of the patient's own body matter, there are fewer restrictions than with other kinds of injections.

The TGA is responsible for regulating the treatment and has been reviewing the issue. But 16 months after submissions closed, the TGA is yet to take decisive action.

A spokesperson says the TGA has been carefully considering feedback on this complex issue, and will take it up with the new government as soon as possible.

Additionally, when stem cell treatment providers talk of promising results and refer to evidence that is in fact weak, they are, Professor Kerridge says, flouting Australian Health Practitioner Regulation Agency (AHPRA) guidelines.

The AHPRA code of conduct includes working within your field of expertise, and using the best available information.

Professor Kerridge says many stem cell clinicians haven't been doing that.

'It's suggesting strongly or weakly there is clinical benefit,' he says.

'It's suggesting strongly or weakly that this is part of conventional medicine. It's suggesting that this has a firm scientific basis. It's suggesting that every administration of this therapy will contribute to research and is contributing to growing knowledge.

'All of these things arguably are false.'

An AHPRA spokesperson said there are a number of investigations underway which they cannot comment on, and urged people considering treatments to ask questions and research evidence of their efficacy.

Hear Ann Arnold's full investigation into the questionable use of fat-derived stem cell therapies on Background Briefing at 8:05am on Sunday, or subscribe on iTunes, ABC Radio or your favourite podcasting app.