Last week, Suzie Palmer, 44, travelled from her home in NSW to the Gold Coast for her second round of stem cell treatments for multiple sclerosis. OnTuesday morning, the wheelchair-bound poet underwent liposuction.
By 2.30pm, stem cells had been partially separated from her abdominal fat, suspended in plasma, and injected intravenously. Her doctor, Soraya Felix, is a cosmetic surgeon and molecular biologist with a sideline in regenerative medicine.
Palmer, a relentlessly upbeat and positive person, says the treatments have helped her cope better with heat, improved her mobility and flexibility and otherwise made her "feel like a normal human being". She has, she says, managed a few steps with a walker, still a long way from "running about, which is my dream".
The rapidly growing stem cell industry is aglow with similarly positive testimonials, notably on behalf of practitioners who offer little documented scientific evidence of their success.
Suzie Palmer is literally the poster girl for stem cell tourism within Australia. You can find her smiling sweetly, along with Dr Felix, on the Facebook page of a group called the Adult Stem Cell Foundation. She is one of an unknown number of unwell Australians pinning their hopes on an unregulated industry that is now under review by the Therapeutic Goods Administration.
The TGA public consultation, which closed earlier this month, was prompted by long-standing concerns raised by Stem Cells Australia that a loophole in the regulations has allowed dozens of doctors across Australia to provide experimental treatments without the ethics committee oversight that registered clinical trials are subject to. These treatments invariably cost $10,000 and up. The loophole is this: while the use of donor stem cells in therapies is tightly regulated, the use of a patient's own stem cells is not.
Professor Martin Pera is the program leader of Stem Cells Australia, which is administered by the University of Melbourne and includes scientists from Monash University, the Walter and Eliza Hall Institute for Medical Research, the Florey Institute and the CSIRO, among others. They are engaged in a seven-year Australian Research Council project to answer the big questions about stem cells and the potential for reliable therapies.
Pera's laboratory at Monash University was the second in the world to isolate embryonic stem cells, and the first to describe their differentiation into somatic cells in vitro.
In a 2014 paper tiled Regulatory Loophole Enables Unproven Autologous Cell Therapies to Thrive in Australia, Pera said that he and co-author Associate Professor Megan Muncie had identified 40 doctors offering stem cell therapies. Most of them "appear to restrict their practice to osteoarthritis and sports injuries", but others were treating a wide range of serious medical conditions, including cystic fibrosis and autism. Neither MS Australia or Cystic Fibrosis Victoria recommend that people living with those conditions seek stem cell treatment outside controlled trials. The National Health and Medical Research Council, concerned by the sudden rise of stem cell tourism within Australia, last year issued a warning that "Unproven stem cell treatments can result in serious health complications such as infection, allergic reaction or immune system rejection and in some cases, the development of cancer."
However Professor Pera writes that "such unproven treatments" are widely promoted by providers via dedicated websites, and endorsed through patient networks and community groups such as an Australian charity claiming to have more more than "900 doctors join and over 400 physiotherapists, chiropractors, osteopaths and other health professionals" endorse the value of what they are achieving. The registered charity in question is the Adult Stem Cell Foundation, which Pera declined to discuss directly.
In a telephone interview, the foundation's founder, Brisbane businessman Bruce Lahey, described Professor Martin Pera as a "bureaucrat". He insisted that stem cell transplants were innovative, not experimental, and had their worth proven "beyond doubt" by a wealth of largely overseas research.
"Why is Monash University the only place [allowed to do] research? Why can't we locate doctors from overseas?I'm a businessman looking for solutions," he says. His solution is to provide referrals to stem cell therapists at home and abroad. He personally knows more than 40 Australian doctors engaged in stem cell work, and has 10 on his books.
At the foundation website, visitors are told to "just fill out the application form for an experimental transplant". "We will be only too happy to advise," it says.
Bruce Lahey, in an email, said applications are sent "to the nearest doctor or best-suited doctor and the clinic contacts and discusses all aspects of their condition" with the patient. He said the foundation receives "no information back from the clinic due to doctor-patient confidentially reasons," nor does the foundation receive a commission. However, Lahey hoped that doctors receiving referrals "will make donations to the ASCF for research purposes." He said the foundation, via its Australasian Stem Cell Registry (which acts as its referral arm), is "a substantial tool for the advancement of their industry."
The Queensland-based foundation's advisory board consists of two naturopaths, an engineer who specialises in hyperbaric oxygen chambers, a Singaporean health coach and medical doctor, a GP who also provides acupuncture and "natural remedies", a corporate operations manager with a history in the health care sector - and Dr Soraya Felix, who is the only member of the board with any actual stem cell experience.
Lahey said the heavy leaning on alternative medicine was to provide a holistic and integrated approach to healing. "We're interested in patients getting the best deal and the best result ... but it's only a band-aid if you don't address the other issues."
He added that Felix, who holds degrees in a variety of disciplines, is one of the most innovative practitioners in the country. The foundation website says she "is currently involved in world-breaking work with stem cells especially in the areas of cystic fibrosis and other serious diseases including all forms of arthritis".
None of Felix's work is part of a registered trial. In a telephone interview, Felix said she planned to register two trials in the next six weeks, and they would detail breakthroughs in the delivery of stem cells. She told Fairfax Media that she performed "two to three surgical procedures a week on patients with multiple sclerosis".
Suzie Palmer believes she was injected with "100 per cent stem cells during the first treatment, and 98 per cent in the second".
This isn't the case, and Felix says as much - she injects a mixture of cells called "stromal vascular fraction" (SVF) which contains between one to 10 per cent mesenchymal stem cells.
According to Professor Pera, and other experts interviewed by Fairfax Media , complete separation of stem cells in just a couple of hours is technically impossible. Dr Felix agreed with that position.
She did not answer Fairfax Media's emailed question as to why Ms Palmer believed she was getting the pure product.
Palmer's one-day treatment has cost her $10,000 so far, money raised by her parents and friends.
Sandra Sharman, 72, is taking part in a registered clinical trial. The retired Victorian nurse and now farmer, suffered from advanced osteoarthritis following a car accident 20 years ago. She applied to take part in a clinical trial at the Melbourne Stem Cell Centre, which is governed by ethics committees at Monash and LaTrobe universities, and costs patients nothing.
When Sharman didn't fit the criteria for the trial, because her arthritis was too advanced, she opted to become one of three private patients in what's called a patient-funded case series, which is being run in tandem with the trial, at a cost of $10,000.
"I was nursing for a long time and I saw lots of joint replacement that had failed and I saw lots of people who were in a lot of pain and I never wanted that," she says, of her decision to seek stem cell therapy rather than surgery.
The results, she says, have been life-changing: most of the pain has gone and she now walks with ease. Sharman's enthusiasm matches that of Suzie Palmer.
According to Dr Julien Freitag, sports physician and senior consultant with Melbourne Stem Cell Centre, 50 grams of fat was removed from Sharman's abdomen. This yielded approximately 50 million of the mixed, stromal vascular fraction cells. (The type of mixture that was injected into Suzie Palmer's vein.)
At this point, Sandra Sharman's sample contained, at most, five million stem cells. The centre's laboratory then spent two to three weeks isolating and growing 100 million stem cells from the original five million. Another week was required to test samples to confirm the cells were viable stem cells - and that there had been no bacterial or fungal contamination.
"These steps are taken to ensure utmost safety," says Freitag. The lab-grown stem cells were then injected directly into Sharman's knee joint.
Freitag believes all stem cell-related treatment and research should be happening under the governance of an ethics committee, but he worries that a heavy-handed regulatory response from the TGA - such as closing the loophole - will lead to prohibitive costs for researchers. He favours the industry remaining self-regulated.
"Australia has the opportunity to be at the forefront of research and development," he says. "It would be a shame for that opportunity to be lost."
Professor Martin Pera said he's not "unsympathetic with those who are struggling to develop new cell therapy treatments, indeed we want to see legitimate efforts encouraged" - but says that self-regulation contains an inherent conflict of interest. But, he adds: "It is possible that a scheme of voluntary regulation, with true independent oversight and mandatory inspections and reporting of outcomes, similar to that which operated in the early days of in-vitro fertilisation in the United Kingdom, might be appropriate" for own-stem cell therapies "involving ... minimal manipulation."
Brian Lahey reckons "the horse has bolted. If the TGA closed down the industry, people will just go overseas."
A spokeswoman for the TGA said no findings will be made any time soon. "There are lots of consultation and regulatory processes to go through, including possible changes to legislation... We can provide no indication of timing of any changes until that process has been completed."