SHEILA DRYSDALE’S husband saw stem cells as a last, desperate attempt to ease his wife’s symptoms of dementia. Sadly, the same day she received treatment in Sydney – 20 December 2013 – Drysdale died, aged 75. In July 2016, the coroner investigating the case ruled that Drysdale had bled to death as a result of a liposuction procedure involved in the therapy, saying it had some ““.
Alarmed by this case – – and others in which unsuspecting people have been harmed (see “Cells behaving badly“) authorities in the US and Australia are introducing new measures to crack down on unregulated stem cell clinics, while supporting those developing legitimate treatments.
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Stem cells hold great promise because they have the potential to mature into and repair multiple tissues of the body. Last year, firms announced encouraging progress towards treatments for diabetes and lower back pain, for example. And for decades, doctors have indirectly used stem cells that are naturally active in blood and bone marrow to treat conditions such as blood cancers.
But in the past few years, hundreds of clinics have sprung up offering stem cell treatments that haven’t been thoroughly tested in clinical trials or approved by regulators.
“There’s a long list of clinics making claims that are scientifically impossible,” says of the UT Southwestern Medical Center in Texas and a past president of the . “They make claims to cure things like Alzheimer’s disease, amyotrophic lateral sclerosis and autism.” Such claims are heavily marketed online and at introductory “seminars” designed to hook punters in. So what can we do to better protect desperate people?
identified 351 firms offering stem cell-based interventions – whether legitimate or unregulated – at 570 locations in the US. Hotspots were California, with 113 clinics, Florida, with 104, and Texas, with 71. Since then, roughly 100 more businesses and 150 more clinics have opened. “It’s continuously expanding,” says at the University of Minnesota, who co-authored the 2016 study and is busy with a follow-up. Australia is also a , with around 60 at the last count.
By comparison, hardly any private-sector stem cell clinics have appeared in western Europe, although eastern Europe has a few. “In Europe, regulators have managed to control untested stem cell treatments quite well, with multiple levels of oversight that make it much harder to do something outside a properly conducted clinical trial,” says of London’s Francis Crick Institute.
Crossing the line
Three factors have driven the rise of private stem cell clinics in the US and Australia. One is ambiguity over whether removing and reinjecting stem cells into the same person qualifies as a standard medical practice, no different to taking a vein from someone’s leg to provide a heart bypass, for example.
If a clinic substantially alters someone’s tissue – say by maturing extracted stem cells in the lab into different types of cells – this potentially becomes a novel therapy, requiring the same testing and approval as a new drug.
But telling who has crossed that line is tricky. Turner’s study found that 61 per cent of stem cell clinics offer treatments based on extracting and reinjecting adipose cells, basically fatty tissue. Some are former cosmetic liposuction outfits that have jumped on the stem cell bandwagon.
Another factor is past lax scrutiny of the field by regulatory authorities like the US Food and Drug Administration (FDA), coupled with a more entrepreneurial climate than in Europe. The third factor is the growth in the US of laws that entitle people to try untested treatments, but potentially deny them legal redress if these go wrong. Such “right-to-try” laws have been passed in 38 states.
Last year, and its counterpart in Australia, the (TGA), independently decided to act. Both proposed regulatory changes to distinguish clinics offering from those with in which tissue or cells are altered outside the body in a way that could constitute a new form of untested treatment.
“If they grow the cells in culture, you could introduce mutations before you reinject them, for example,” says Morrison. It could also be dangerous to reinject fat cells in a different place, such as directly into the bloodstream or brain.
Campaigners for a crackdown have welcomed the regulations, which are to be finalised in the US and Australia later this year, but some fear the measures won’t go far enough. “Until we see details of the new TGA regulations, it’s impossible to decide how effective they will be,” says of the Royal Prince Alfred Hospital in Sydney, and the main author of a .
In the US, experts fear that the FDA lacks the resources to meet the challenge posed by investigating hundreds of clinics. At a in November, FDA commissioner Scott Gottlieb implied there are only a few unscrupulous actors, and these could be targeted as a priority. So far, the FDA has only openly investigated three clinics. The most recent warning notice . The other two probes were before the new rules were unveiled.
But critics say the FDA underestimates the scale of action needed. “It’s not just a couple of bad centres,” says Turner. “They say they’ll pick ones at greatest risk, but it may mean that only the most outrageous businesses get targeted while the rest carry on as normal.”
A further obstacle is that people themselves – encouraged by the right-to-try laws promoted by libertarian organisations such as the – .
The institute says on its website that less than 3 per cent of terminally ill US patients get access to experimental treatments through clinical trials, and argues that the rest should be allowed to take drugs that have passed initial safety tests. It says that more than a million Americans die each year because of FDA red tape that can delay full approval by as much as 15 years. “For those who do get access, it’s often too late,” says its website.
But supporters of an FDA clampdown on dubious stem cell treatments say that widening access plays into the hands of clinics offering unregulated therapies. “People don’t understand that the right-to-try laws are an opportunity to victimise patients and be immune to the consequences,” adds Morrison.
“There’s a long list of stem cell clinics making claims that are scientifically impossible”
At present, federal law upheld by the FDA trumps state law, but there are currently bills under consideration to introduce right to try across the US. Given the combined impacts of right-to-try laws and a lack of resources, there are fears that however well-intentioned, the FDA crackdown will falter.
“They need more inspectors, to send out more warning letters, and the thing that would make most difference would be criminal charges, proof of fraud and that people were harmed,” says Turner. “Convicting someone of fraud would have the biggest impact.”
Cells behaving badly
People treated at stem cell clinics selling unregulated therapies have been seriously harmed, been offered expensive treatments that appear to have no chance of working and have even had their condition made worse.
Just last month, a woman who claims she was blinded by a stem cell treatment against the firms that administered it.
In March 2017, a report emerged of three other women with age-related macular degeneration who developed severe vision loss following injections of fatty tissue supposedly containing curative stem cells into their eyes, one of them ending up blind. They had each paid $5000 for the treatment, and all three sought emergency treatment for the side effects in 2015.
A US woman with paralysis who was treated in Portugal by injecting nasal stem cells into her spine developed severe discomfort eight years later. The cause, revealed in 2014, was a 3-centimetre growth at the injection site of what appeared to be nasal tissue plus bone fragments.
Last year, Â鶹´«Ă˝ exposed the case of an Indian clinic offering stem cell treatments to 14 people with Down’s syndrome, a condition caused by inheriting an extra chromosome. Although the clinic claimed this proved beneficial, experts contacted by Â鶹´«Ă˝ were at a loss to see how treatment with stem cells could possibly do any good.
This article appeared in print under the headline “Stemming the tide”
