When you think of an ecosystem, do you imagine something like a forest or jungle full of different organisms?
I usually do, but over the last few years I’ve also been thinking about this concept in a different way. I’ve been viewing the broad stem cell arena as an ecosystem. In that spirit, I’ve recently published a new paper in Regenerative Medicine that delves into the idea of a “stem cell ecosystem”.
This system has many parts and if you view it historically it has been getting increasingly complex. Another way to view the stem cell arena is as an “interactome”, which is a term us scientists use for molecules that interact, but here I’m meaning it as a system of stem cell “parts” (people, organizations, agencies, etc.) that interact in different ways.
Here’s the paper’s abstract:
“The stem cell and regenerative medicine arena has become increasingly complicated in recent years with thousands of people involved. There are as many as a dozen or more main groups of stakeholders, who together may be viewed as one ecosystem that is now rapidly evolving. The nature of the ecosystem and its evolution have major implications for not just those within it, but also for medicine and society at large. Here, I describe this ecosystem and its evolution, as well as the negative impacts within the ecosystem of a constellation of hundreds of unproven for-profit clinics and related businesses. Finally, I propose approaches for how to positively influence and drive the future of the global stem cell ecosystem.”
My thought is that through defining and staying aware of the stem cell system, we can better drive positive change. We can also better anticipate problems and try to stay ahead of them or at least plan for them. The unproven stem cell clinic area, what I’m calling a constellation of related businesses, has become a major problem in this system and for society more broadly. You can see it depicted in blue and purple in the figure diagram from the paper.
As this constellation continues to expand heading towards probably 1000 clinics soon in the U.S. alone, we need to stay on top of it and its place in the system. Some would say it’s already too late for that. One possibility for why the FDA has been so inactive on stem cell clinics historically is that the agency was “behind the curve” as to the current state of the stem cell ecosystem and how dramatically the clinic part was expanding. The current FDA may change that, but we’ll see.
If you consider yourself part of the stem cell arena, where do you fit into the above figure outlining the many moving parts? In this interactome, you might have several roles. Overall, do you positively impact the system? Do you think any key constituents are missing and if so, which ones? In my paper I also discuss how there are other science ecosystems such as in the cancer field, and perhaps they all share some common steps in their evolutions.
I love this article and the approach you take here! It’s incredibly helpful to the layperson and helps me to make sense of this highly complex situation, and how the care-seeking public fits into it. Imagine creating a markov chain of each treatment type and variation and visualizing it moving through the process.
Each type of stem cell source, delivery method, condition treated, clinic size, doctor credential, device manufacturers, geography, all figure into this. If we could model this fairly accurately for even the US it could provide insight into what is driving the most revenue, the most healing, the most interest from doctors, which clinics are facing which types of challenges, and help to see what regenerative medicine will look like in the next few years.
One of the stem cell clinics (from FL) that was sued by the FDA is the same one running full front page ads in the Tucson and Phoenix newspapers I believe. I imagine these clinics write off these nuisance suits as a cost of doing business.
I have read with interest your comments on the stem cell clinics that have sprung up over the past several years. I somehow was invited to one of their local presentations recently, which I attended (great dinner at least). It was extremely misleading from telling attendees that FDA did not regulate stem cells because they are natural products to boasting they could treat floaters in the eye with a simple injection. After the presentation I introduced myself as a Professor at the University of Arizona, Director of the Biorepository and someone who has worked in this field for the past 25 years. I also pointed out the inaccuracies and insisted they cease and desist such misleading dog and pony shows. However, ads from such clinics have shown up regularly as full page advertisements in our local paper on a daily basis for the past several week.
After talking with my local university IRB, which is unable to do anything, I contacted the FDA which was not interested. As the leader of the local stem cell clinic is neither an MD, DO or NMD but rather a chiropractor I contacted the state Board of Medicine as this seemed to be the practice of medicine without a license. Again, no response and no actions. Luckily I have a good friend who is a federal DA who referred the case over to their in-house consumer fraud division as possible mail fraud. We will see how far that goes.
My point is, no one seems to care unless hundreds or thousands of people are involved or until someone is severely injured or killed. This seems to be the weak link in the defense against such scams. Not sure what can be done to stop this onslaught.
David,
Thanks for going the extra mile on this to try to make something happen and for letting us know. It is very discouraging, but I’ve been working on it for years and there is some hope out there. For instance, one glimmer that something potentially can be done is the FDA filed suit in federal court against 2 stem cell clinic firms that to me are particularly concerning (https://ipscell.com/2018/05/in-historic-step-fda-doj-seek-injunctions-on-2-key-unproven-stem-cell-clinic-firms/). But the number of clinics is so high now and there are so many chiropractors getting into it lately selling what often isn’t even really stem cells that the FDA has to do much more or it can feel like a drop in the bucket. State medical boards should do more, but with the chiropractors I don’t know if these boards can do anything and I’d guess the chiropratic boards won’t. We’ll see.
Is it right to try to remove the opportunity for people to access healing? Are you confident that the non-M.D. who is performing these procedures is not helping the majority of people? If he is disappointing some, is that problematic if he is clear on the consent form that improvement is not guaranteed. It’s a best-effort deal.
Look, at the very least you are in good company in that the FDA cares NOTHING about regulating even ESTABLISHED procedures like ESIs, birth epidurals, back surgery, and lumbar punctures. 10,000s are injured per year with no action. Medical injury is
What is hard for me as an arachnoiditis victim from a lumbar puncture (no other risk factors – unnecessary procecure, no back issues) is that the ONE thing that has helped me and other arachnoiditis warriors (over 1,000) have outstanding improvement in pain levels and overall quality of life is being hampered by the FDA. FULL DISCLOSURE and NO GUARANTEEs are the foundation of patient consent. PROHIBITION is the ENEMY of freedom and where is freedom MORE important than in access to health care??
Yes, let’s regulate ALL procedures and so-called drugs effectively, with a focus on ACTUAL REPORTING FROM PATIENTS not just hospitals. Guess what, no surprise that the VAST MAJORITY of medical injuries are UNREPORTED and STEM CELLS help a LARGE NUMBER OF CHRONIC INJURY PATIENTS.
The BEST stem cell clinics use third-party reporting/ review sites for patients to record the pleasure or dissatisfaction. Trustpilot is such a site. I believe we’ll get far more rapid and effective improvement in health care by having ACTUAL, DECENTRALIZED patient-driven reporting than POLITICIZED, REGULATORY, IGNORANCE-DRIVEN, FEAR-DRIVEN, CREDENTIAL-DRIVEN results.
MDs are key drivers in a system that kills over 200,000 Americans each year. They are not Gods, the majority graduated in the pre-regenerative medicine era, and unfortunately the SYSTEM within which they work is HIGHLY litigious, creating STRONG disincentive to report or even consider injuries that aren’t UNDENIABLE. Plausible deniability is the rule in this complex situation, and the patient is actually in a unique position to know what happened (though of course not perfect) and their voices are NOT heard.
Stem cells are OUR medicine. Let US have it from ANYONE who has the ability to deliver them to us, be they MD, MA, PhD, or BA, DO, whatever acronym. Let the results – and the patients – speak for themselves.
What about cost?? You are DRIVING UP COST!! What would it cost if FDA focused on results instead of credentials? How many die from suidical pain because of efforts like we see here? I know people who evidence suggest would be alive and relatively well today had they be afforded access to their own body’s healing.