This BBC Radio 4 programme 'The Stem Cell Hard Sell', hosted by Lesley Curwen, aired on 7 January. It explored stem cells, their potential for good, as well as the hype that surrounds them.
Some stem cells can become many types of cells, thus can potentially be used to repair damaged tissues.
We start with Anne who has Multiple Sclerosis (MS). Her immune system has been destroyed by chemotherapy and needs to be rebuilt. She is in hospital, about to receive a stem cell transplant. Enter Dr Majid Kazmi, the Chief of Cancer Services at Guy's and St Thomas's Hospital and the Director of the Haematopoetic Stem Cell Transplant Programme at London Bridge Hospital. He pioneered stem cell transplants for MS patients over a decade ago. He speaks about the potential of regenerative stem cell technology. So far, so good, for stem cells. But then things take a darker turn.
Dr Kazmi warns that 'people have jumped on the bandwagon of stem cells' and have started marketing them without evidence.
Curwen jumps from London to the USA to outline the explosion of unproven stem cell treatments there (also called 'regenerative treatments'). She mentions a blog called 'The Niche', written by stem-cell researcher Professor Paul Knoepfler from the University of California (I can attest it is worth a read to those looking for more information, from academia to 'Goop').
Professor Knoepfler reports that the hype is exacerbated by researchers too, where some scientists 'cross the line' and portray stem cells as 'almost miraculous or magical'. This, he says, contributes to the problem.
Stem cells can be sourced from other people's umbilical cord blood, or the patient's own fat or bone marrow, and then injected back into the body. These treatments are now being marketed for arthritis, heart disease, cerebral palsy, cancer, Alzheimer's disease and autism. Professor Knoepfler says the science is unsupported – for example, trials may be conducted without placebo controls, or improvement assessed with subjective patient questionnaires.
Not only is the evidence to justify these treatments lacking, but things can and do go wrong.
Some patients were infected by the same contaminated batch of umbilical cord blood in 2018. They won their suit against the US company Liveyon. 'Fortunately there have been no deaths from this,' says their lawyer, 'but it's only a matter of time'.
Another example is a 2017 case where three women in Florida paid $5000 to have stem cells, obtained from their own fat, inserted into their eyes to treat the eye condition macular degeneration, for which there is no recognised cure. They were blinded as a result.
The Food and Drug Administration (FDA) tell Curwen of yet another case where a patient had stem cells injected into their spine who subsequently developed a spinal tumour.
The link between cancer and stem cells is not elaborated on in the programme, which I think required more coverage. Stem cells have a lot in common with tumour cells (eg proliferation, near-immortality, etc), and cancer is one of the obvious potential side effects.
Dr Sean Morrison researches stem cells and cancer at the University of Texas Southwestern. He attributes regenerative treatment popularity to a 'very strong placebo effect', which is then used by the companies for their marketing testimonials. 'When the patient dies in the end', he adds, 'you never hear anything more about it'.
The FDA is playing catch-up to a mounting problem and has given illegal clinics until the end of the year to comply with regulations.
But it's not just the USA that has the International Society for Stem Cell Research worried. Professor Megan Munsie from the University of Melbourne, Australia, chairs its ethics committee. She says that globally, 'we don't know who's had what, whether it's affected them, whether it's harmed them'.
Indeed at this point, listeners may have been wondering, as I was, what exactly is happening in the UK. Curwen had some good news for us: there are no reported cases of donor cells (eg from umbilical cords) being used for treatment in the UK, which reduces the chances of infection. The bad news is that a patient's own cells, usually from liposuction, can be used for private treatments.
The editor-in-chief of the Bone and Joint Journal, Professor Fares Haddad told the BBC that there is a 'sham scientific legitimacy created by those who have a vested interest...creating false hope for patients'. He has personally treated patients who contracted infections and developed blood clots.
Curwen interviews father and son Howard and Mark, who both went to the Regenerative Clinic in London with joint problems, and regretted it. 'I feel stupid' says Mark. 'I was desperate'. How much difference did the stems cells make? 'None. Like, none,' he says.
My outrage was further aroused when the chief executive of the Regenerative Clinic Simon Checkley came on the show. When Curwen accuses him of jumping ahead of the science, he argues that the evidence is good but scarce because the field is so new. He throws out statistics (82 percent of 1700 patients have had a 'really good' result, but 10-15 percent don't respond), then dismisses 'scepticism and push-back from the traditionalists'. At this point I half-expected him to do a Michael Gove and say people have had enough of experts!
More shockingly still, the BBC reveals that a woman was blinded in one eye during treatment for osteoarthritis of the jaw at the Regenerative Clinic. This complication was not reported to the Care Quality Commission (CQC) for over a year. Checkley gives us more statistics: 'Our complication rate is 0.05 percent'; 'the CQC rated us good in every category'. 'For legal and ethical reasons, I can't comment on individual cases,' Checkley told the BBC.
Apart from the CQC, what protection is there for patients? In particular, do stem cells count as medicine? If so, they could be regulated by the Medicines and Healthcare products Regulatory Authority. But they don't. Could they be regulated as a transplant, by the Human Tissue Authority (HTA)? Again, no. These products are essentially unregulated - 'a loophole' says Imogen Swann, former head of regulation at the HTA (read her 2008 article at BioNews 465). This loophole was intended to allow for skin grafts, however, the regulations are now in need of an update.
The most disturbing thing I heard as this episode comes to the end, with Curwen's investigation of an unlicensed clinic based in London, Belgrade and Dubai, called the Autism Regenerative Centre which will, for £9500, inject stem cells into the spine or brain of autistic children. The clinic claims it has performed this on 500 children globally, aged as young as three. We hear from a UK mother who spoke to the clinic manager. He promised to 'remap the brain area' of her child with stem cells.
Professor Declan Murphy at King's College London, a leading authority on autism research, is 'speechless' when told about the clinic's promises. Is injecting stem cells into the spine a 'completely natural treatment', as the clinic website claims? 'It is absolutely not a natural treatment', Professor Murphy says.
This concern about opportunistic commercialisation is also the conclusion of every clinician and scientist interviewed in this thoroughly researched and balanced episode. For me, it highlighted the importance of medical regulations. The future of stem cell treatments is exciting, but we are 'not there yet', concludes Professor Munsie. So if you hear someone promising a stem cell miracle, to quote the FDA advert, 'Don't believe it!'