This really came out of different experiences with some of my clinic patients who have pursued these therapies, both in registered controlled trials, but then also in ways that are essentially off-label and not regulated. There is a patchwork of regulation for these sorts of things in the United States, but they are often more easily accessible without much oversight in different countries because of the variability in regulatory environments...
This really came out of different experiences with some of my clinic patients who have pursued these therapies, both in registered controlled trials, but then also in ways that are essentially off-label and not regulated. There is a patchwork of regulation for these sorts of things in the United States, but they are often more easily accessible without much oversight in different countries because of the variability in regulatory environments. One thing that we have seen as a concern, that unfortunately is not tracked systematically, is adverse events from stem cell treatments. In addition to the fact that they don’t necessarily work, they can be incredibly dangerous due to that lack of oversight. Part of the goal of the session was to try to spread awareness about what sort of side effects may arise for patients.
Part of it is unfortunately using therapies that may not work. So, even if they’re completely safe, we often have patients spending tens of thousands of dollars and not getting any sort of confirmed benefit from treatment. Something that has been really interesting to track is the adverse events. There are mundane things that we may expect just from any medical treatment, especially if it involves injections into the spinal cord or IVs: things like infections, chronic pain, and other sorts of procedural implications. But we also see a number of idiosyncratic risks such as infections that are very uncommon that are just based on having access to the intrathecal space. This includes one case that we had published on a mycobacterium abscessus infection in the central nervous system, and then even tumors of non-host cells. There are a few case reports of glial proliferative neoplasms of the stem cell donor cells growing in the patient, and those are not able to be treated with conventional methods. There are a lot of these unusual challenges because stem cells have a lot of potential, both to modulate the immune system and to proliferate.
I think part of the goal of the session was to really raise awareness of the problem. Stem cells have certainly been on the forefront for at least the last 20 years or so, as far as providing new ways to treat patients. The only really legitimate approval at this time is using stem cells to repopulate the immune system after a stem cell transplant, which is of course used a lot for hematological malignancies, and then increasingly in autoimmune diseases, which were a few talks earlier in the session.
There’s not any legitimate use, but we’re not very good at warning patients away from this happening. There was a survey of neurologists in 2018 that looked at this problem, and the majority were not necessarily comfortable even discussing this topic, and I would say most of us probably don’t bring it up in routine clinical practice. I think we’re often focused on managing symptoms and selecting therapies, but we don’t push the envelope to discuss things that patients are interested in. I think, unfortunately, what we’ve seen from social media and some of the aggressiveness of marketing from these stem cell companies, is that patients still remain very interested in this, despite the lack of evidence. Once we had awareness, the goal was to: one, work with professional societies and patient advocacy groups to improve that awareness, but then also to really try to have a one-on-one conversation with all the patients in clinic when you’re thinking about treatment – just to bring these things up and invite a dialog should a patient be interested in this, before they’re just relying on unvetted sources like social media.
