After years of legal battles, the FDA has secured what appears to be a decisive federal court victory in its effort to regulate one type of stem cell clinic. This ruling has implications for other clinics too.
The U.S. Supreme Court just declined to review a key case that the FDA had won on appeal at the 9th Circuit Court over a group of clinics selling adipose cells. As a result, for the foreseeable future, it seems that fat cell preparations are officially drugs.
That status now stands unless the FDA reverses course or the law changes.
What does this mean for the field and patients?
The defendants here are California Stem Cell Treatment Center, Cell Surgical Network, et al. You can see the denial of the writ of certiorari above or read the actual SCOTUS decision not to review this case along with its decisions on other requests.
If SCOTUS had taken this case, given the court’s current makeup, I believe the defendants had some chance to prevail.
Importance of this case
Why is this case so important?
First, marketing of adipose cell procedures has been widespread in the U.S. even beyond those involved in this case. Perhaps as many as 300 firms were selling such injections across perhaps all 50 states. Yet the FDA had defined the cell preps as unapproved drugs. This set up a conflict.
There have also been a handful of negative outcomes in various states. For example, a few patients lost their vision after eyeball injections with fat cell preparations. This led to the other main case in this sphere where the FDA earlier prevailed against a firm called US Stem Cell Clinic in Florida. The federal district court ruling (by summary judgment) there was also upheld by the 11th Circuit Court.
More practically speaking, as a stem cell biologist, I don’t believe there was much chance of consistent, lasting benefit to clinic customers overall from these adipose cell preps. No conclusive, controlled clinical trials showed that adipose cells, often marketed as stromal vascular fraction (SVF) or “fat stem cells”, were useful or safe for specific medical conditions.
I should note that adipose cell preps are often complex mixtures of many cell types with actual stem cells maybe only being ten percent or less. Also, after injections, the cells in these preps would likely only hang around for a matter of days or weeks. As a result, there’s just a narrow window to somehow provide long-term benefit.
What happens next?
In my view, the ruling of the first judge who heard this case, Jesus Bernal here in California, was incorrect. I thought that he seemed negative about the FDA from the start.
What might we see next in this case?
Now, as best as I understand things as a non-attorney, the case will go back from the 9th Circuit to Bernal with adipose cells defined as drugs. Bernal will then issue a ruling.
While Judge Bernal is bound by the Ninth Circuit’s ruling on the legal definition of SVF as a drug, he still retains discretion over how to apply that ruling, including what kind of injunction or remedy, if any, is appropriate.
In addition, it is possible that the FDA/DOJ could opt to no longer pursue an injunction here. I have more on the politics of this arena toward the end of the post.
I asked Stanford Law Professor Hank Greely, an expert on the FDA, for his thoughts on the Supreme Court ruling and what happens next. He also mentioned the possibility of the new administration changing course:
“This marks the end of the line for this fight, which started when FDA sued California Stem Center over its use of “stromal vascular fractions,” which FDA claimed were drugs. The case is notable because the Center got a federal district judge to agree with it; the Court of Appeals for the Ninth Circuit then reversed and this week the Supreme Court declined to review that reversal. The denial of review is NOT a decision on the merits—the same issue could come up in another case and the Supreme Court could take that case and hold that these stem cell mixtures are not “drugs” (or biological products) under its jurisdiction. Or the Trump Administration’s FDA could stop trying to enforce this position. Or it could make regulatory changes to exclude these concoctions from FDA oversight. Or it could get Congress to amend the act to exclude them. There are no final victories. But this is much better news than a decision to hear the case would have been…a good thing for public health.”
I was hoping Hank would have been more optimistic about the future.
Clinic industry pivot coming?
Assuming the FDA continues to enforce its current position on adipose products, many clinics may now pivot to biologics that are less clearly regulated or have not yet faced significant FDA action. What are the options?
Many may begin to primarily sell PRP or platelet rich plasma. PRP, as it is widely used for orthopedic conditions, does not appear to be a drug. At least to my knowledge the FDA has never signaled it is a drug.
In addition, some adipose cell clinics may shift to selling minimally manipulated bone marrow cell procedures. The FDA mostly has seemed to view those as not being drugs when used for orthopedic conditions.
Avoiding future regulatory battles by marketing PRP or bone marrow aspirates might be appealing to clinics tired of going around and around with the FDA.
Here too there could be some complexity though.
I wonder whether if hundreds of firms start selling bone marrow injections for conditions outside of the orthopedic sphere if the FDA might have to take action on non-homologous use of bone marrow.
One time I directly asked the FDA about non-homologous bone marrow procedures. The agency indicated that such use would trigger a drug classification. For example, if you market autologous bone marrow cells for treating vision loss or neurological conditions, the marrow product in theory would be a drug. Yet, as far as I know the FDA hasn’t taken action on such uses that have actually happened. That has left things somewhat uncertain.
Other options for clinics that might move away from adipose cells
Circling back to adipose cells, what are other possible options for the clinics that might be impacted by this case?
Perinatal products, including exosomes, could be another focus moving forward for some clinics. These are cheap for clinics to buy and new suppliers keeping popping up. Yet, the FDA has been quite active on perinatal cell products. It has issued numerous warning letters related to these products including some this year.
I wouldn’t be surprised to see some of the impacted clinics start selling another hot but unproven biologic: peptides.
Political winds could still shift cell therapy oversight
In the bigger picture, there is still strong pressure for less rigorous FDA oversight of cell therapies. The FDA also seems more governed by politics.
A growing number of state stem cell laws directly say FDA approval isn’t needed for use of some “stem cells”. These laws specifically focus on perinatal cells that the FDA has consistently said were drugs.
This sets up an eventual possible showdown between federal law — which preempts state-level rules — and states passing ‘right-to-try’ or deregulatory stem cell laws. If a clinic relies on a state law to administer an unapproved biologic, and FDA takes enforcement action, the legal collision could spark new litigation. An example might be a Florida clinic marketing stem cell shots (based on the state law there) that the FDA views as unapproved drugs.
The influential Goldwater Institute, which you’ll see mentioned in the SCOTUS decision above, has advocated for less stringent FDA oversight on biologics too.
What does RFK Jr. want to change on stem cells?
RFK Jr. famously posted last year that the FDA was suppressing stem cells, peptides, and other supposedly helpful things. That statement is still hanging out there unresolved. What did he mean? Could he make some major change in oversight here?
I feel like there could be another shoe to drop on this.
Some dramatic move seems likely since Kennedy himself reported getting unproven birth-related stem cells in Antigua. The doctor who gave him those cells, Chadwick Prodromos, also seems to have Kennedy’s ear. Are discussions ongoing in D.C. that could lead to big changes at the FDA on oversight of cells?
Circling back to the adipose cell court case, I have not seen any indication that Kennedy is interested in adipose cells. He has focused more on perinatal cells.
Oversight of cell therapies overall remains extremely volatile overall. The chess match here continues despite this important denial by SCOTUS.
Let’s pretend for a second that “We the People” ever gave the “Federal” government the authority to limit ANY drugs (the Constitution is a document of enumerated powers, and NOWHERE in the constitution is the government the authority to restrict or prohibit what one injects, ingests, or inhales into his own body. That said, let’s pretend…). With that, every year tens of thousands of us travel outside of the country to get medical procedures done – safely, and effectively, in other countries, because the FDA violates our right to “pursuit of happiness”. A department set up to improve health, should not be standing in the way of procedures that do exactly that. To say that there are limited studies is a total farce. Stem cells have been used for nearly two decades now and millions of patients have had successful outcomes.
And to claim that replicating one’s own ells makes it a “drug” would be comical if it were not co criminally negligent. The very same agency that approved (at a handsome profit mind you) drugs such as Fen Fen, wants you to believe that they have your health in mind when it restricts your ability to re-inject YOUR OWN stem cells (remember back to biology class, cells divide, they do not reproduce, thus, these cells are IDENTICAL to the cells that were taken out of your body).
On the plus side, each and every American that gets fed up and leaves the country for ‘medical tourism’ learns first-hand (as I have), just how expensive the broken American medical system is. One can go to Costa Rica, have a procedure done – by an American doctor* – get a vacation in a beautiful country, and still save thousands of dollars in the end. The more people who wake up to the Big-Pharma, Big-Insurance scam perpetuated by the FDA, the sooner the system will crash, and it can be rebuilt with the patients needs at the core.
* this is because due to the massive amounts of red-tape, and burdensome insurance paperwork, so many American doctors have simply left the country so that they can actually practice medicine again.
@Joseph,
I disagree with much of what you wrote, but let’s start with areas of agreement. The US healthcare system has serious problems including massively inflated costs. Big pharma has major issues. Many health insurance companies have major issues. It’s crazy that so many Americans go bankrupt because of healthcare costs.
However, these things don’t seem to be the FDA’s fault. It’s a total myth that the FDA is somehow overregulating stem cell therapies to help pharma.
Also, cells removed from the body and grown in a lab can be dramatically different than the cells inside your body. You’re just totally wrong about the “identical’ claim. Take it from someone who has spent decades growing human cells in the lab. They change. In the case of stromal vascular fraction from fat, there is no stromal vascular fraction in the body. It’s a unique, lab-created drug product.
Although I agree that SVF therapy needs oversight and regulation, you are absolutely incorrect that there are no controlled trials showing benefits. You should do a pubmed search and you will see that there are many. It is a variable product with variations patient to patient in the cellar composition. People look to you for science and truth. Do your homework before you malign a technology. Glad to debate this topic.
@Bob, thanks for the comment, but I don’t think there have been consistent, well-controlled and sufficiently powered clinical trials show efficacy for specific conditions. What do you see as the top 1-3 papers on SVF reporting the strongest clinical trials?