Leigh Turner’s new Cell Stem Cell paper on the unproven stem cell clinic industry following up on our collaborative work together in 2015-2016 is great work but very discouraging.
He found more than 2,700 clinics run by more than 1,000 firms in the U.S. This is several-fold growth since 2016.
I’m very glad that Leigh has continued this line of research.
Stem cell clinic industry is still growing fast
One major conclusion is that the FDA’s approach just has not worked overall.
They’ve stepped up their game in the last 4-5 years, but it seems clear that sending out more (but still relatively few) warning letters and churning out hundreds of untitled letters just isn’t enough.
Another lesson is that it seems the FDA’s more than three-year grace period (technically a period of “enforcement discretion”) for clinics to come into compliance was specifically a major misstep.
Leigh’s new data tell a story of a largely rogue industry that continues to mushroom in size across the U.S. despite challenges to them like the pandemic and the FDA being more aware of the problem.
It’s worth noting that this industry could potentially go by some kind of new name because there are far more than stem cells sold at these clinics. One growing area is exosomes, which are drugs and require premarket approval from the FDA.
Then there are many other non-stem cell products, some of which are still called “stem cells.” Some of these products don’t even contain live cells of any kind.
Data was collected on the number of businesses and clinics selling purported stem cell products in each state.” L Turner 2021, Cell Stem Cell.
New stem cell clinic oversight ideas: fines & more
What to do now?
I wrote earlier this year that the FDA stem cell clinic approach needs a radical overhaul.
Fines. Perhaps the best way to proceed is to issue monetary penalties against many hundreds of non-compliant clinic firms. The first of such waves of fines could go to the 500+ firms that have received untitled letters from the FDA and who remain noncompliant. The bottom line for the clinics is making money so regular noncompliance fines of $50K or $100K would have major impact.
Warning letters without inspections. Another idea is to issue hundreds of warning letters to these and other firms. Warning letters are a more serious regulatory step potentially leading up to filing suit for injunctions to stop clinic businesses. Traditionally the FDA has done in-person inspections before issuing warning letters but that isn’t practical for such a large industry and in an emergency kind of situation, which I believe this is. For this reason I suggest the agency break new ground and issue warning letters without requiring themselves to have done an in-person inspection.
It would also help if state medical boards did far more.
More oversight ideas: injunctions & PSA campaign
More injunctions. Ultimately, the FDA might have to find a way to issue relatively large numbers of injunctions working together with the DOJ, but there are serious obstacles to that including the need for a huge legal team. Still, it is doable if there is the will.
I believe the FDA is currently in a waiting game on this front to see the verdict in federal district court in California on the suit it has filed for injunction against a large chain of clinics.
Public service announcement ad campaign. Finally, with thousands of clinics out there and the industry still growing it is time for a national PSA ad campaign by federal agencies to warn the public about this problem.
Given the size of this industry the risk to the public is huge and the industry threatens the authority of the FDA itself.
This article doesn’t paint the picture accurately at all. May 31st, 2021 is the end of the 3 year moratorium (ended up being 3.5 year). If those polls were taken today it wouldn’t even be 10% of the original total. A majority of those clinics were selling allografts and today there are very few allograft companies left. Signature who has an IND is selling allografts for knees and a biologics company out of FL. The rest stopped making Wharton’s jelly etc type allograts. Most clinics took action and discontinued use long before May 31st. The clinics left are trying to fly under the radar and are working with AMI or have followed Regenexx’s lead and switched to Bone Marrow Aspirate for orthopedics. Maybe you should look into AMI. They are the only “chiro” clinics left having their fearless leader tell them that the FDA can’t do anything to them.
How can you say there is no proof? How many tens of thousands of people need to say that their symptoms/condition improved dramatically before you agree that the treatments are working for folks? If you really don’t feel that way about it, then why lobby for billions of dollars from CA tax dollars as your streets are starting to look like third world countries..
I am not doctor just a patient searching for relief from Osteoarthritis. I found a promising article on stem cell success. https://pubmed.ncbi.nlm.nih.gov/33591794/
I don’t know what Regenexx offers in comparison to this. But stem cells from your own body seem to offer the best results.
Here is a simple Infographic on EFFICACY Adipose for Orthopedic conditions. https://www.linkedin.com/feed/update/urn:li:activity:6864197566129586176
Centeno has one for bone marrow as well.
What is your reference on “many harms” as directly related to cells themselves i.e.NOT improper medical technique or contaminated tissue from illegitamate umbilical cord companies.
Totally agree !
an interesting call for action on the regulatory agencies that are already burdened by special interests, lobbyists and other manipulative parties. The mesenchymal stromal (stem) cells have been studied extensively. There are two Nasdaq listed companies that have developed proprietary products ( MESO, PSTI) which were used with FDA compassionate use permission in getting patients off ventilators during the March 2020 height of Covid-19 infections in NYC.
Why are these products not available for use in the continuing development of therapies for patients affected by Covi-19 ? MESO has 36 clinical trials listed on clinical trials.gov.
The restrictions and regulatory aspects that the FDA imposes has driven this aspect of MSC therapy offshore, out of the USA (an economic loss). This does not benefit the citizens of the USA by making a potentially appropriate therapy unavailable.
This type of environment allows “shady” clinics to operate with a distinct advertising venue, under the radar which appeals to some people, and not within the scope of medical insurance.
The answer is not more enforced regulations but having the FDA encourage clinical trials, having the NIH sponsor extensive clinical trials, funding comprehensive cancer centers to conduct clinical trials, and university biomedical centers to conduct clinical trials and research.
By forcing this area of the translational medicine and regenerative biotechnology into “off label use” the data is not gathered, the protocols are not measured, the results are not tabulated. Thus why not encourage and support this through measured means, rather than driving this “underground” and into “shady practice”.
This is not an issue of medical freedom. Cells once expanded or manipulated are drugs and must be treated as such.
Saying all autologous therapies are save is like saying all plant derived compounds are safe.
“Given the size of this industry the risk to the public is huge and the industry threatens the authority of the FDA itself.”
With all due respect, that’s an overreaction multiplied by an exaggeration to the exponent of a hyperbole.
The true “risk to the public” is unduly burdensome federal regulations on autologous SCTs, therapies which could and should be healing people right now. These therapies are best regulated at the state level, not federal.
What truly “threatens the authority of the FDA” is its denial of the voices of innumerable Americans who are demanding more health sovereignty and an end to the longstanding tyranny of the pill paradigm. Freedom, liberation and emancipation should be the North Star of our medical ethics.
That said, I agree that the FDA is waiting for a verdict in the current litigation. Without question, a verdict against the FDA will be a verdict for sick and diseased Americans. SVF can help many people. It already has and is.
Thank you for permitting me to comment.
There’s no good scientific evidence that what the clinics are selling actually helps people as you claim. In contrast, we know of many harms. The clinics also do not exactly embrace medical ethics.