A total of 30 Canadian businesses have been found to provide untested and potentially unsafe stem cell treatments in a recent study.
Dr Leigh Turner, a bioethicist at the University of Minnesota who has investigated similar unlicensed stem cell companies in the USA, identified the firms through online searches. The 30 businesses sold the stem cell treatments to a total of 43 clinics across Canada.
'I'm very concerned about the risks associated with businesses making dramatic claims about stem cell treatments for a wide range of diseases and injuries without doing the careful, costly, and time-consuming work needed to develop a compelling evidence base for such representations,' Dr Turner said in an interview with RegMedNet.
The companies selling the treatments frequently made bold claims about their potential, while underplaying the common risks and adverse effects associated with them. 'There's a genuine risk that patients and their loved ones will be preyed upon by clinics making particularly egregious advertising claims,' said Dr Turner.
Most of the companies sold treatments based on autologous stem cells, made from the patient's own cells. The companies sold the treatments as targeting a range of diseases, including neurological conditions, lung diseases, immune conditions and sexual dysfunction. Some also sold treatments for cosmetic procedures.
Clinics charged as much as CA$3500 (£2090) per injection. Many charged smaller additional fees for injections at secondary sites.
As well as risking patients' health, the provision of unproven stem cell treatments damages trust in bona fide clinics providing evidence-based treatments, Dr Turner argued. 'Offering patients hope when in fact what is being extended is false hope can be damaging to patient-physician relationships and result in substantial loss of trust,' he told Gizmodo.
Dr Turner has previously studied the market for unproven stem cell treatments in the USA, where there have been more investigations into unlicensed stem cell clinics. In 2017, the FDA launched a crackdown on these clinics (see BioNews 916).
However, the marketplace for unproven and unlicensed stem cell treatments has not received significant national attention in Canada, Dr Turner said.
'Perhaps it will take a tragedy of some kind – a highly publicised fatal outcome or news media coverage of seriously injured patients, as has happened in the US – for Canadian legislators, regulators, policy-makers and other parties to better understand why such businesses need to be subjected to stringent regulatory oversight,' Dr Turner told RegMedNet.
The research was published in a study in the journal Regenerative Medicine.