Many people want to point fingers at who is to blame for the seemingly glacial progress in the field of stem cells and implicate the massive regulatory burden as one of the main impediments. The FDA is very large overburdened government agency who is not necessarily the villain here. They are in charge of protecting public safety. I'm not saying that they are perfect, but if you want somewhere to point the finger, I would start with the legal system and the litigious environment in the US, which makes organizations such as the FDA extremely paranoid about exposing the public to any heightened risk, even under informed consent.
Regenerative medicine and cell therapy, in particular the use of stem cells of various origin for a multitude of conditions, is extremely complicated field of medicine with a short research history comparatively speaking. Although this newer research in the last couple of decades is based upon a much larger older body of work, there is still much to be tested and many risks to be mitigated.
Probably one of the biggest concerns I have today as a physician-scientist who first entered the field of stem cell biology over 20 years ago is that because of the hype and the public perception of stem cells as a universal panacea, a growing group of individuals, who in my opinion are largely underqualified, are taking this therapy into the clinics with an approach that smacks of reckless abandon. There are now many people receiving stem cells from questionable practitioners at exorbitant prices with almost no real clinical evidence for efficacy.
We do know based upon the number of people that of been treated that the majority of stem cell treatments that are being administered today are safe, at least for the short term. Hopefully this means that these practitioners are not doing any harm right now. That said, this is not the way we do things medically in the United States. Like it or not, there are rules to be followed and there's guidance to be headed and many brilliant people have spent their entire careers working diligently and as fast as they can to bring these new therapies to the clinic safely and with the greatest effectiveness.
At this point, to just bypass the last lap of the race if you will is somewhat unethical and could be even considered cheating the system. Unfortunately in this case, "the system" involves vulnerable patients at risk who are in many cases grasping for hope through alternative treatments.
The only people I think who should be administering stem cells now and in the near future are those with a real medical training and scientific backgrounds in the field of cellular biology. Most of these clinicians should have academic pedigrees in research and the clinical experience to understand more clearly what happens when stem cells are delivered to the body.
Unfortunately, we have a mixed bag of practitioners out there practicing now, mostly primary care docs and physical medicine & rehab physicians who seem to be just seeking a lucrative outcome by doing procedures on the cash basis that they would not have ordinarily performed had the regulatory hurdles been cleared more efficiently years ago.
As far as I can tell, very few practitioners administering stem cells today have any scientific background in stem cell research or clinical trials nor do they have the experience of taking cellular therapies through the FDA or working closely with companies in the field.
Hence, I am quite worried about the current state of stem cell therapy in the U.S. as it is now at risk for being forever marred by some early charlatans who have bypassed the legitimate pathway to becoming stem cell experts and clinicians. It's a shame, but if you ask me, I think the stem cell field in America already has one black eye thanks to these individuals and I'm hoping it doesn't get a second one.
My personal scientific and clinical opinion is that stem cell therapy is indeed efficacious, but to what degree at this time is unknown. I am comfortable saying this because I have run an academic stem cell lab, performed my own research including extensive animal studies, and I have been through the FDA more than once having had to demonstrate both safety and efficacy in multiple animal models and in humans. I also know that there are many variables which we do not have worked out yet, the biggest ones are related to which type of stem cells to use, how many to give in terms of dosage, and what frequency in terms of how many injections or how often somebody might need therapy in order to get a satisfactory result.
My advice for the consumer is to do your homework, know everything you can about the therapy you are contemplating receiving and the practitioner who is going to administer it. Make sure the product you are getting is safe and proven to have efficacy for your specific problem. Also, make sure that your practitioner is actually a medical doctor with clinical and scientific training in Cell Therapy and Regenerative Medicine.
If you have any problem finding the answers to these or other questions pertaining to stem cells, just give me, Russ Reiss, a call at Park City Performance Medicine. I am happy to help guide you to finding the right care.