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ANALYSIS STEM CELL CLINICS

Stemming the tide

A mix of medical ambiguity and libertarian laws has fuelled untested
stem cell treatments. Is it too late to crack down, asks Andy Coghlan

SHEILA DRYSDALE’S husband Research.“They make claims to although eastern Europe has a a novel therapy, requiring the
saw stem cells as a last, desperate cure things like Alzheimer’s few.“In Europe, regulators have same testing and approval as a
attempt to ease his wife’s disease, amyotrophic lateral managed to control untested new drug.
symptoms of dementia. Sadly, the sclerosis and autism.”Such stem cell treatments quite well, But telling who has crossed
same day she received treatment claims are heavily marketed with multiple levels of oversight that line is tricky. Turner’s study
in Sydney – 20 December 2013 – online and at introductory that make it much harder to do found that 61 per cent of stem cell
Drysdale died, aged 75. In July “seminars”designed to hook something outside a properly clinics offer treatments based on
2016, the coroner investigating punters in. So what can we do to conducted clinical trial,”says extracting and reinjecting adipose
the case ruled that Drysdale had better protect desperate people? Robin Lovell-Badge of London’s cells, basically fatty tissue. Some
bled to death as a result of a A 2016 study identified 351 Francis Crick Institute. are former cosmetic liposuction
liposuction procedure involved firms offering stem cell-based outfits that have jumped on the
in the therapy, saying it had interventions – whether stem cell bandwagon.
some“troubling hallmarks of legitimate or unregulated – at Crossing the line Another factor is past lax
‘quack’medicine”. 570 locations in the US. Hotspots Three factors have driven the rise scrutiny of the field by regulatory
Alarmed by this case – the first were California, with 113 clinics, of private stem cell clinics in the authorities like the US Food
known death from a stem cell Florida, with 104, and Texas, with USandAustralia.Oneisambiguity and Drug Administration
treatment – and others in which 71. Since then, roughly 100 more over whether removing and (FDA), coupled with a more
unsuspecting people have been businesses and 150 more clinics reinjecting stem cells into the entrepreneurial climate than
harmed (see“Cells behaving have opened.“It’s continuously same person qualifies as a in Europe. The third factor is the
badly”, below) authorities in the expanding,”says Leigh Turner at standard medical practice, no growth in the US of laws that
US and Australia are introducing the University of Minnesota, who different to taking a vein from entitle people to try untested
new measures to crack down on co-authored the 2016 study and is someone’s leg to provide a heart treatments, but potentially deny
unregulated stem cell clinics, busy with a follow-up. Australia is bypass, for example. them legal redress if these go
whilesupportingthosedeveloping also a hotspot for stem cell clinics, If a clinic substantially wrong. Such “right-to-try” laws
legitimate treatments. with around 60 at the last count. alters someone’s tissue – say by have been passed in 38 states.
Stem cells hold great promise By comparison, hardly any maturing extracted stem cells Last year, the FDA and its
because they have the potential to private-sector stem cell clinics in the lab into different types of counterpart in Australia,
mature into and repair multiple have appeared in western Europe, cells – this potentially becomes the Therapeutic Goods
tissues of the body. Last year, Administration (TGA),
firms announced encouraging independently decided to act.
progress towards treatments for CELLS BEHAVING BADLY Both proposed regulatory
diabetes and lower back pain, for People treated at stem cell clinics treatment for the side effects in 2015. changes to distinguish clinics
example. And for decades, doctors selling unregulated therapies have A US woman with paralysis who offering “minimally invasive”
have indirectly used stem cells been seriously harmed, been offered was treated in Portugal by injecting routine medical procedures
that are naturally active in blood expensive treatments that appear to nasal stem cells into her spine from those with more radical and
and bone marrow to treat have no chance of working and have developed severe discomfort eight invasive ones in which tissue or
conditions such as blood cancers. even had their condition made worse. years later. The cause, revealed in cells are altered outside the body
But in the past few years, Just last month, a woman who 2014, was a 3-centimetre growth at in a way that could constitute a
hundreds of clinics have sprung claims she was blinded by a stem cell the injection site of what appeared to new form of untested treatment.
up offering stem cell treatments treatment launched a lawsuit against be nasal tissue plus bone fragments. “If they grow the cells in
that haven’t been thoroughly the firms that administered it. Last year, New Scientist exposed culture, you could introduce
tested in clinical trials or In March 2017, a report emerged of the case of an Indian clinic offering mutations before you reinject
approved by regulators. three other women with age-related stem cell treatments to 14 people with them, for example,” says
“There’s a long list of macular degeneration who developed Down’s syndrome, a condition caused Morrison. It could also be
clinics making claims that severe vision loss following injections by inheriting an extra chromosome. dangerous to reinject fat cells in
are scientifically impossible,” of fatty tissue supposedly containing Although the clinic claimed this a different place, such as directly
says Sean Morrison of the UT curative stem cells into their eyes, proved beneficial, experts contacted into the bloodstream or brain.
Southwestern Medical Center in one of them ending up blind. They had by New Scientist were at a loss to see Campaigners for a crackdown
Texas and a past president of the each paid $5000 for the treatment, how treatment with stem cells could have welcomed the regulations,
International Society for Stem Cell and all three sought emergency possibly do any good. which are to be finalised in the US

22 | NewScientist | 20 January 2018