There’s a new Wyoming stem cell bill that poses risks to the public.
The so-called Stem Cell Freedom Act would allow clinical use of non-FDA-approved cells in that state.
With this, Wyoming joins other states such as Florida that are pushing back on the FDA. The new Florida stem cell law is likely already causing problems there. One key difference is that Wyoming’s act specifies autologous MSCs. Other states have focused more on perinatal cells like MSCs.
There are big risks to the Wyoming stem cell act.
States vs. the FDA on “stem cells”
For context, these state bills are in part inspired by the Right-To-Try (RTT) movement, but often extend the use of non-FDA-approved “stem cell” drugs to less serious conditions than are typical for RTT.
As many of you know, this kind of state legislation saying no FDA approval is needed runs afoul of federal law, which preempts state laws. In other words, states legally cannot just say something such as unapproved stem cell drugs are OK if the FDA says the use is illegal. Still, supporters of such state laws tend to point out how the feds have tolerated so much state legalization of pot.
Today’s FDA could also do something similar with certain cells, such as those that RFK Jr. favors, via enforcement discretion.
Despite the risks, it seems that RFK Jr. may be ready to make the FDA harmonize with anti-FDA stem cell laws. You might recall that Kennedy himself also disclosed getting an unproven stem cell procedure.
Wyoming stem cell bill
Here’s the news I first saw on the new Wyoming “stem cell” bill: Barlow introduces Stem Cell Freedom Act for Wyoming. State Sen. Eric Barlow, a veterinarian, is one of the four GOP sponsors.
From the article:
“The proposal gives patients access to stem cell therapies using their own cells, citing the slow pace of federal approval processes and the need for states to act when Washington fails to keep up with medical innovation,” a news release from Barlow’s office said. Barlow has been involved in the policy conversation since 2024, after being approached by a constituent.”
As I said, the bill (Senate File 48) specifically allows for the use of mesenchymal stromal/stem cells or MSCs. It is rather short on details or limitations, but mentions IRB approval. Does that mean just about anything goes at unproven MSC clinics if this becomes law and a clinic has an IRB?
Recall that there are some IRBs willing to approve what stem cell clinics are doing even if it is ethically or legally questionable. As a result, IRB approval in such cases may mean less than it seems. By contrast, for serious sponsors who work with the FDA, IRB approvals mean a great deal. You have to wonder about an IRB that specifically would OK use of cellular products that are drugs but lack FDA approval.
Clinic doctors get a free pass?
The act also says this, “Notwithstanding any other provision of law, the Wyoming state board of medicine shall not revoke, fail to renew, suspend or take any other action against a physician’s license based solely on the physician’s recommendations to a patient regarding access to or treatment with stem cell therapy or the performance of stem cell therapy, provided that the recommendations or procedures are consistent with medical standards of care.”
Yet, if Wyoming physicians are potentially violating federal law and FDA regs with the marketing of cells, shouldn’t the medical board be able to take action?
Supposedly “The legislation provides strong safeguards, informed consent and ensures medical standards are met.” I’m not convinced. This is going to end up hurting people in Wyoming if it. becomes law. One of my predictions for 2026 has become a reality already with this new law. You can see the other stem cell predictions for this year. Some others look to be realized soon too.
Notes
- MSCs are generally not pure populations of stem cells. Instead, they are heterogeneous mixtures in which true stem cells are just a small subpopulation. Even so, these bills/laws often just say “stem cells” so I sometimes refer to them as state stem cell laws, but keep in mind the cells in question are often not exactly just stem cells.
- Here’s more coverage of the Wyoming “stem cell” bill that provides helpful context and perspectives from Leigh Turner.
If the show is right now in SoCal, I’m here too ☺ and totally agree with you.
What is the good clinical trial evidence that S. Korea is doing so well avoiding knee replacement because of cell therapies?
Not sure I understand your question. But just doing an AI search in GOOGLE, “Is there any evidence that the South Koreans are avoiding invasive knee replacement surgeries the result of the stem cell drug Cartistem?” The following was revealed…
“While there is no definitive statistical evidence that the South Korean population is avoiding invasive knee replacement surgeries exclusively due to Cartistem, there is clear evidence that the drug is being increasingly utilized as a preventative or delay-focused alternative for specific patient groups.
Market Trends and Adoption
Rapid Adoption: Since its 2012 approval, more than 32,000 patients in South Korea have been treated with Cartistem. Sales have grown at an annual rate of roughly 36%.
Strategic Positioning: Medipost, the drug’s manufacturer, specifically markets Cartistem as a way to delay or prevent the need for Total Knee Replacement (TKR). They emphasize that TKR implants have a limited lifespan (approx. 10 years), whereas stem cell therapy seeks to restore natural knee function.
High Success Rates: Clinical trials reported that 97% of recipients showed significant cartilage restoration after 48 weeks, with lasting improvements observed in five-year follow-ups.
Contextual Knee Surgery Rates
Despite the success of Cartistem, overall knee replacement rates in South Korea have continued to rise, largely driven by an aging population.
Rising Volume: From 2011 to 2018, the number of knee arthroplasty patients in Korea increased from roughly 44,000 to 64,000.
Demographic Shift: While total surgeries are up, there is evidence that the number of TKR patients under the age of 70 has decreased, while surgeries for those over 70 have increased. This suggests that regenerative therapies like Cartistem may be effectively delaying surgery for younger or middle-aged patients.
Economic Impact: A cost-effectiveness analysis found that Cartistem is a viable societal alternative to traditional microfracture surgery, with a 99-100% probability of being cost-effective for treating knee osteoarthritis.
In summary: While Cartistem has not caused a net decline in the total number of knee replacements due to Korea’s aging demographic, it has become a widely accepted surgical alternative that allows thousands of patients to potentially bypass or postpone more invasive procedures. ”
As far as Makary is concerned….I cannot say that I’m a big MAGA person. Also, I don’t believe in the maxim that in order to save a village we have to destroy it relative to the FDA. On the other hand no one commissioner can make that big a difference in a system that is so entrenched. Even before PDUFA, FDA commissioners were always under unrelenting pressures from the drug makers to get their products approved. On another topic, I do like that RFK has criticized the FDA for its acceptance of receiving much of it’s funding from the industries that they are supposed to be regulating. I like RFK’s critique of the FDA relative also to Peptides, Psychodelics and Stem Cells and the American diet. Unfortunately, despite my cheerleading for the South Koreans, their equivalent of the FDA also receives much of its’ funding from the industries they are designed to regulate.
I was talking to my uber driver on the way home from a regenerative medicine conference. He wondered about a lot of things- FDA, vaccines, stem cells, and asked me who I believe. I told him that as a scientist, I don’t believe anyone. I need facts, and facts are not associated with any one person or website. That’s why I say that “evidence shows…”
Not sure what weird things you are talking about with regard to other countries and their regulatory policies relative to that which they approve onto their markets. You seem to have a lot of faith in the FDA; After all you refer to FDA as having the gold standard. And certainly, that is one way of viewing the FDA, But, I’ll have to disagree with you there. I think their policies with regard to biologics are self serving and bureaucratic. I don’t blame states for pushing back with their own policies particularly with regard to a person’s autologous cellular material. I think they are on the right track.
I find it unsettling that South Korea is not the home of Harvard and Stanford schools of medicine or MIT or Cal Tech. Yet the South Koreans discovered something that by all accounts (except the FDA’s) is helping their populations to avoid highly invasive knee replacement surgeries. Maybe our FDA and our entire country has something to learn by the South Koreans example instead of just doubling down on our own policies. My guess is that their product will probably help later with other degenerative diseases involving the hip and spine. Meanwhile the U.S. and its’ corporate health care system will still be depending on surgery.
@Doug, What is the good clinical trial evidence that S. Korea is doing so well avoiding knee replacement because of cell therapies?
Also, I’m curious what you think of the FDA under Makary? Do you think it’s better?
Yes, I believe that is correct. Normally it might be 10-15 years, but I believe based on their data and previous studies, they were essentially given a voucher to skip to Phase 3.
Reason being, generally, the FDA is the gold standard. Lots of other countries approve lots of weird things, FDA wants to have a final check which makes sense.
However, I could see the FDA changing the laws a bit and allowing things under conditional approval sometime soon. Not sure.
If I’m reading MEDIPOST related websites correctly, their UCB/KOA injections won’t be available in the United States for at least another five years (2031)??? Is that right?? Please correct me if I am wrong. If not, that five year time frame seems an awfully long period to wait particularly if this treatment has been available in South Korea since 2012? https://parentsguidecordblood.org/en/news/cartistem-cord-blood-derived-therapy-knee-arthritis#:~:text=Medipost%20is%20a%20South%20Korean,exposes%20the%20subchondral%20bone5. Am I correct??? Meanwhile the United States is preparing only for a Phase III clinical trials?? Are we that far behind in the U.S.??
I’m undecided on whether these state laws are a good or bad thing, I try to stay open-minded, and I often find myself flip flopping the more I learn…
However, one hidden danger of these laws that’s not discussed is the damage to the “real” stem cell companies, the ones going through proper channels and proving what they have actually works before they make money.
Those companies go through hell and back, fight for investors, actually prove disease-modification… only to be cut in line by 361s & state frameworks like this.
For instance, Medipost just got $140M for their UCB KOA therapy. I’m sure that wasn’t easy.
https://www.businesswire.com/news/home/20260109323917/en/MEDIPOST-Inc.-Announces-%24140-Million-in-Funding-to-Accelerate-Late-Stage-Clinical-Development
But when/if that product hits the clinic (IND just issued last week I believe), we know it works. Whereas 361s and these products allowed in WY/FL/UT you really have no idea, some % is placebo, likely a lot, hence why you see universities try to replicate what these 361 companies say online and can’t get the same results.
Not sure what the answer is.
@EV Tech,
I agree about the hidden danger with the laws. I’m curious, you say that you’re kind of torn on the state laws, but what are the potential upsides? Freedom of access to unproven cellular drugs? I’m not sure that’s worthwhile. Maybe just for folks with a fatal illness who has exhausted other options and consents to the risks and likely lack of benefit? These state laws are generally not restrictive in that kind of way.