Are stem cells for autism promising?
The answer so far is a clear “no”.
Even a Duke team that was for a time very upbeat about the potential of umbilical cord cell therapy for autism seems to have lost that enthusiasm. For example, they stopped their EAP of cord cells for autism. I also don’t see that they have any active trials in this space on Clinicaltrials.gov either. In addition, the Duke Cryo-Cell deal working toward cell infusion clinics including potentially for autism is apparently finished.
So, is the idea of stem cells for autism or cell therapies more broadly pretty much dead?
Oddly, no.
In fact, for those specifically selling unproven cells for autism, there may have never been a better chance to operate without FDA issues.
How is this possible?
RFK Jr.’s preoccupation with autism is a key element. If you combine that interest with his enthusiasm for unproven medical approaches like certain kinds of stem cells, the result is increased risks to thousands of autistic children.
A recent duo of articles from Ed Pilkington of The Guardian sheds more light on what’s going on in this space.
RFK Jr. & autism summits
Here are the new articles:
- Autistic children injected with unapproved stem cell treatments supported by RFK Jr
- ‘Autistic kids are being experimented on’: inside America’s booming market for unproven stem cell infusions
I highly recommend them. In this post I’m only touching on a few of the things he found. While I had previously suspected Kennedy would be into the idea of stem cells for autism, what Ed uncovered was worse and more widespread than I imagined. For example (“he” here is Kennedy):
“At the same time, largely unnoticed, he has given his backing to alternative health providers moving to fill the gap. Kennedy appeared by video link at the first two annual summits held in San Diego by Autism Health, a leading advocate of stem cell infusions for autistic kids.”
These summits sound highly problematic to me. Some of the more specific offerings are particularly troubling. I’ll start with the one that seems riskiest.
Kids injected with animal stem cells?
I thought the idea of injecting humans with animal stem cells was mostly a thing of the past, but then there was this (emphasis mine):
“Those providers included Mike Chan, a Malaysian physician who presented the San Diego summit with a protocol that he practices from his clinic in Bangkok. It involves injecting autistic children in the buttocks with high doses of stem cells extracted from slaughtered sheep and rabbits.“
This kind of procedure makes no sense to me. It comes with many risks too. Note that the animal cell injections supposedly reverse aging too. Of course.
As a side note, it was 13 years ago that a lady recognized me on an elevator as “the stem cell guy”. She told me that she gets sheep cell injections outside the US.
There appear to be more unproven autism cell clinics in the US now too even if they seem focused on human cells.
If the data are so discouraging, how can this be allowed to happen?
Kennedy and Tracy Slepcevic; directing kids to Mexico
It’s frustrating to see our HHS Secretary connected to unproven offerings for autism. More from The Guardian:
“Kennedy described the organiser of the San Diego summit, Tracy Slepcevic, as a “good friend”. In January, the health secretary appointed her to his remodelled Autism Coordinating Committee, which guides federally funded autism research. Slepcevic is the mother of an autistic son and a proponent of alternative therapies for autism including stem cell infusions.”
RFK Jr.’s autism committee reminds me of the anticipated stacking of the Pharmacy Compounding Advisory Committee (PCAC) by Kennedy with fans of unproven pop peptides like BPC-157. Or at least people who will likely be largely a rubber stamp for what he wants.
In terms of unproven cells for autism efforts, reportedly one focus is a new trial by the Cellular Performance Institute (CPI) in Tijuana. I’d imagine that many of the families who participate will be Americans.
Here in the US, state laws are also part of the problem. For example, the recent Florida stem cell law opens the door to unproven therapies. There are similar laws in other states too.
US clinics in the game
Perhaps as a result, more US clinics are getting into “stem cells for autism” space too. (I put “stem cells” in quotes sometimes because what is actually offered may not be true, living stem cells.)
Will the FDA care?
It’s hard to say as Kennedy is essentially the boss of the FDA now. As I’ve written before, it’s possible the FDA is already exercising enforcement discretion for certain kinds of favored (but unproven) cell approaches that in the past the agency might have actively prohibited. Note that in my opinion cord cells are almost certainly unapproved drugs when used for autism here in the US. That means that you should need FDA approval in advance before selling them, which to my knowledge nobody has.
In Pilkington’s second article he interviewed Dr. Chadwick Prodromos. You might recall that Prodromos provided Kennedy with stem cells in Antigua.
From Pilkington: “Since Prodromos’s exchange with Kennedy, the Guardian has learned that he is now offering umbilical cord stem cell infusions to autistic children from two of his US clinics – in Naples, Florida, and Dallas, Texas.”
Again, there’s no solid reason to think that umbilical cord cells can consistently be beneficial for autistic children. The Guardian also mentions other clinics offering cells for autism including:
“…a clinic, North Florida Stem Cells, in Orange Park, Florida. The doctor who founded the clinic, Eric Weiss, says in one of the TikTok videos that “umbilical cord blood is like the chicken soup for healing”.
How about data?
The other thing that comes to mind is where the US clinics get the umbilical cord and other cellular material? In the past, the FDA has seemed concerned about introduction of umbilical cord cell drugs into interstate commerce.
How do the state laws come into play?
While Florida’s law is very limited in what the non-FDA-approved “stem cells” can be used for there (and on first glance it doesn’t seem to include autism), clinics are interpreting the law differently.
The same kind of thing is happening in other states with anti-FDA stem cell laws.
A reminder that federal law and regulations trump state law, but if the FDA chooses to do nothing, then in practical terms state law may prevail.
With all of this in mind, in the bigger picture, why is Kennedy so upbeat on this unproven cells for autism stuff?
Personal experience & belief over data put kids at risk
He is apparently guided more by personal experience and ideology than data. For example, he has gotten unproven stem cells and used pop peptides. Now he seems to want less FDA oversight of these things.
Relying more on anecdotes and not on solid data is a dangerous health policy approach for an HHS Secretary to use, especially when they try to control the FDA.
What does all of this mean practically speaking?
Getting back to stem cells and autism, the end result of the specific, unfounded enthusiasm by Kennedy and others in his orbit for unproven cells for autism will be more children being put at risk. Families given false hope and out hard-earned money. There are health risks too.
More broadly, it’s also bad for the FDA’s mission and authority if it is forced to tie its own hands behind its back on important issues. So, for at least one or two more years, we’re likely to see more kids getting injected with unproven cells, which is very unsettling.
What about state AGs?
An interesting potential paradox is that while as we’ve discussed several state laws allow non-FDA-approved stem cell procedures and so enable clinics in their borders, state attorneys general could push the other direction, particularly if families complain or kids get hurt.
We’ve seen state AGs be very active and successful in the stem cell clinic space. Could Kennedy make state officials more reluctant to take action?