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Feature

Safety, ethical concerns raised over private stem cell dry eye treatment

06/06/2018
A private stem cell clinic in Sydney has been charging patients thousands of dollars to treat the symptoms of dry eye disease with procedures described by experts as unproven and potentially dangerous.

The business, Olympus Stem Cells – with sites at Circular Quay, Lane Cove, Rosebery, Mount Druitt and Sydney Olympic Park – is one of 80 such clinics offering autologous stem cell treatments across Australia, however Olympus is the only business that advertises treating the symptoms of an eye condition. Despite the clinic promoting the therapy as “a highly effective means of alleviating pain and discomfort for people suffering a variety of conditions”, medical experts are concerned.


“It’s damaging to the whole stem cell field and to the medical profession, because these are treatments that patients will pay for, often they’re very expensive, with no guarantee that they’ll work, and with real risks to their vision.”
Stephanie Watson, USyd

The deputy director of the University of Melbourne’s Centre for Stem Cell Systems, Dr Megan Munsie, has been following the rise of these clinics nationally and she told Insight that the treatments were placing Australian and visiting international patients at risk of physical, financial and psychological harm.

“Just because the cells are autologous, that is they come from the patient rather than a donor, [it] does not guarantee that they are risk free. How the cells are obtained, prepared, stored and administered all carry risk and can change the risk profile,” Munsie said.

“These interventions are expensive – usually many thousands of dollars – and patients are often encouraged to return for repeat ‘top-up’ procedures. Claims of likely benefit or improvement, or a willingness to attempt to help are not enough. Like all medical interventions, autologous stem cell-based products, should have solid scientific evidence that they work and are safe, gathered from properly conducted clinical trials, before they are promoted.”

Olympus founding director Dr Russell Vickers is a pain management specialist with multiple qualifications including dentistry, chemistry, and anaesthesia, but no medical degree. According to Vickers, his formal stem cells training amounts to a course he took in 2010 from the now-defunct Stemcore training program attached to the University of Queensland.

“It was only a short one, probably a two week intensive. That’s all you need to know, stem cells once you get a hold of it is pretty straightforward. But it also depends on your background training,” he said.

Vickers added that the dry eye procedure was new to Olympus and that it was important to note the clinic did not treat the cause of the condition itself.

“We’re treating the symptoms of a medical condition, but we’re not altering a medical condition. That’s for ophthalmologists; that’s their job. We don’t cross into their territory at all, wouldn’t touch it,” he said.

According to Olympus’ website, its procedure involves harvesting 20–30cc’s of fat from the patient’s abdomen under local anaesthesia, before it is converted into stem cells and stromal vascular fraction. Approximately 1–2cc’s of these stem cells and SVF are then injected into the lacrimal and meibomian glands of each eye, while some are also injected into the mouth.

Yet, despite its claims of a proven track record of “providing safe, effective treatment”, Olympus’ dry eye therapy offers no guarantee as to its success, and the website says it is the patient’s responsibility to “fully investigate the proposed treatment and be satisfied that they are fully informed.”

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Additional concerns

Along with queries related to the effectiveness of the stem cell treatment, other aspects of the clinic’s approach to dry eye have also raised concerns. University of Sydney stem cell researcher and eye surgeon Professor Stephanie Watson suggested the business’ explanation of dry eye indicated a limited understanding of the disease.


“We’re treating the symptoms of a medical condition, but we’re not altering a medical condition. That’s for ophthalmologists; that’s their job.”
Russell Vickers, Olympus Stem Cells

“The website refers to Sjögren’s syndrome which affects the lacrimal gland, but this is not very common. Most people have evaporative dry eye, which is meibomian gland dysfunction and there’s no clinical evidence that injecting anything into a single gland would be helpful,” Watson explained.

“Just because you can harvest stem cells from elsewhere in the body and inject them into a gland doesn’t mean they will work as stem cells. It’s like throwing a brick at a house – you don’t actually know that the stem cell has gone to where it should be, or that it’s even going to stay there.”

Watson also warned there were safety implications associated with injecting anything around the eye – especially when performed by unqualified practitioners.

“The meibomian glands are tiny and they have openings right on the eyelid margin, very close the eyeball, so it is potentially dangerous to inject any substance into them. In America, sham stem cell trials have been reported and patients have been blinded by having fat stem cells injected into their eyes. The New England Journal of Medicine recently referred to such practices as ‘The Wild West’ of stem cell medicine,” she said.

“It’s damaging to the whole stem cell field and to the medical profession, because these are treatments that patients will pay for, often they’re very expensive, with no guarantee that they’ll work, and with real risks to their vision.”

Vickers said the procedures were primarily performed on patients who had dry eye as a result of LASIK surgery and cited a multitude of papers he had published in peer reviewed journals to dispute the characterisation of stem cell therapy as unproven and high risk. He also said his brother – maxillofacial surgeon Dr Peter Vickers – was more than qualified to perform the injections.

“Stem cell therapy is incredibly low risk. Ask an ophthalmologist how many stem cell operations they’ve done? That’s what you need to do – ask them where the proof is that it’s high risk,” he said.

“We’re not treating the condition, we’re treating a symptom of it. There is evidence, and it’s my publications. That’s the evidence.”

While the Therapeutic Goods Administration (TGA) does not currently regulate autologous stem cell clinics, it has responded to industry concerns by announcing regulatory changes that are aimed at protecting consumers from the off-clinical trial use of experimental therapies. These changes are due to come into effect in July and should see an immediate reduction in advertising and greater scrutiny on some clinics, however provision of autologous stem cells within hospitals will remain unaffected.

Image courtesy: Flickr | Vishal Kapoor

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