Aged 20, a Canadian man suffered a serious spinal injury in a trampoline accident, leaving him partially paralysed. With no options remaining, he decided to take what probably seemed like a small risk considering the potential benefits: an experimental stem cell therapy. First, cells with the ability to develop into multiple different cell types were extracted from the lining of his nostrils. Those cells were then transplanted into the site of his spinal cord injury as part of a clinical study.
The hope was that the treatment would help the injury to heal as it had done in some animal experiments, alleviating his chronic pain and perhaps even reversing some of his paralysis. Unfortunately, the treatment was a failure. About a decade after the treatment, the patient noticed that some of his remaining motor functions were slowly deteriorating, and the cause was soon identified: a benign tumour in his spinal cord. Analysis of the tumour left doctors in no doubt about its origin – it was composed of cells derived from the nose.
People with a life-changing or fatal condition will understandably grasp at anything that could potentially help them, even if it means risking an unproven treatment or straying from conventional medicine. Sometimes, that’s an experimental injection of stem cells.
The field of regenerative medicine has been chasing stem cell therapies for decades. We all have stem cells throughout our bodies. These cells are few in number, but are able to divide and develop into multiple different cell types. For example, stem cells in the bone marrow can generate any type of white or red blood cell. Stem cells play a vital role in healing – when tissue is damaged, stem cells get to work producing new specialised cells to repair the injury.
In stem cell therapy, stem cells are procured (often extracted from the patient) and then reintroduced back into the body. Stem cell therapy has few approved medical uses, one of which is restoring the bone marrow following chemotherapy/radiotherapy in people with blood cancers. Why stem cell therapy currently has so few applications is the subject of another article, but many are hopeful that they could one day be helpful in all kinds of diseases. If you inject stem cells into someone with dementia, heart disease or cerebral palsy, might some of those cells not find their way to where they need to be and start fixing the damage?
For some people it seems worth a shot, even if the relevant clinical trials are still in their early stages. After all, it’s just an injection, and with your very own cells – what is there to lose? Unfortunately, there will always be people willing to prey on the desperate and the misinformed.
If you look for them, they are not difficult to find – thousands of private clinics offering stem cell therapies as treatments for anything from Alzheimer’s disease to erectile dysfunction. They offer injections of various stem cell types for prohibitively expensive sums, often leading to the need for crowdfunding campaigns. They show testimonials of patients whose condition improved and often cite legitimate scientific papers, but don’t adequately communicate the premature nature of the research. And, because these are not clinical trials, there’s no way of knowing if any improvement that does occur was the result of the stem cell therapy, or something else entirely.
Many would argue that patients, especially if they are severely ill, should be able to decide for themselves if they want to risk their money and health on an experimental treatment. To do this, however, they must be properly informed about the benefits and risks. Many private clinics use deliberately vague language and statistics that make their stem cells sound like golden bullets for any disease you can think of, when the reality is closer to a shot in the dark. One 2021 study in the UK concluded that 80% of clinics operating in the country displayed an ‘ethically questionable’ portrayal of stem cell therapy.
Most egregiously, videos, articles and websites promoting these clinics are usually silent on the risks associated with stem cell therapies. We already mentioned the risk of implanted cells developing into tumours. People have also gone blind after receiving stem cell injections into their eyes. Adverse reactions to injections and contamination of the cells by bacteria or viruses during their handling are also serious concerns.
So, if these treatments are unproven and potentially dangerous, why are they legal? The answer is that many of them aren’t, but regulatory agencies can be slow to enforce their own rules.
As of 2021, the US Food and Drug Administration (FDA) applies similar regulations to stem cell therapies as it does to drugs. This means that, regardless of where the stem cells are coming from and regardless of whether they are modified outside of the body, a stem cell therapy can only be given if it is an FDA-approved treatment for a disease, or if it is being given as part of an approved clinical trial. However, many clinics try to fly under the radar in various ways, such as using low stem cell counts or placing treatment centres in other countries.
Legal action has been taken against some stem cell clinics, but has not always been successful. In December 2022, a district court in California ruled (against precedent) that stem cell therapies could not be regulated ‘as drugs’, a decision that the US government has appealed.
Despite everything that has been said, some people may still be determined to explore treatments using stem cells. How are they supposed to navigate this area? Based on the FDA’s advice, you should first find out what government body is responsible for overseeing stem cell therapies in the relevant country. Said organisation should have a list of stem cell-based treatments that have been approved for use. Otherwise, stem cell therapies may be available as part of a clinical trial that has been approved by the relevant regulatory body. There are many such trials underway for a wide range of diseases. While being part of a clinical trial doesn’t magically make a treatment safe, the procedures being used will have been scrutinised to ensure that they are as safe as possible, and that participants are fully informed of what risks do exist.
If a clinic appears to be offering an unapproved therapy outside of a clinical trial, or is located in a country where stem cell therapies are unregulated, then it is possible that the procedure has not been checked to make sure it meets basic safety standards. In fact, without oversight, there’s no way of knowing if the injection being offered contains a reasonable dose of stem cells (or any cells at all!)
Stem cell therapy is a very legitimate pursuit as a treatment for a range of diseases, but they currently have very few proven uses in humans. Private stem cell clinics may charge tens of thousands of dollars for a product that might not work while downplaying the significant risks, and most patients are not equipped to recognise this. They detract from legitimate clinical trials and give us no useful scientific data. More aggressive action by regulators and more coordination between different countries would be helpful: let’s have more clinical trials and less snake oil.
Olfactory mucosa autografts in human spinal cord injury: a pilot clinical study https://doi.org/10.1080/10790268.2006.11753874
Intramedullary cervical spinal mass after stem cell transplantation using an olfactory mucosal cell autograft https://doi.org/10.1503/cmaj.181696
Stem-cell clinics in the UK: a web-based study https://doi.org/10.2217/rme-2021-0072
FDA Warns About Stem Cell Therapies https://www.fda.gov/consumers/consumer-updates/fda-warns-about-stem-cell-therapies
Ninth Circuit Appeal May Significantly Affect FDA’s Authority to Regulate Stem Cell Clinics https://www.ropesgray.com/en/newsroom/alerts/2022/december/ninth-circuit-appeal-in-stem-cell-clinic-case-likely-to-have-significant-impact-on-fdas-authority
Title image by stefamerpik, Freepik
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