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Quackademic medicine at the Marcus Center for Cellular Cures: Stem cells for autism

Stem cells are an unproven therapy for autism, but that isn’t stopping Duke University’s Marcus Center for Cellular Cures from teaming with a for-profit stem cell company to market this quackery for big bucks.

The Marcus Center for Cellular Cures at Duke University bills itself as “harnessing biology through technology” and further describes itself thusly:

The Marcus Center for Cellular Cures (MC3) at Duke University School of Medicine has been established to bring together physicians and faculty across medicine and engineering at Duke to develop cellular and biological therapies for autism, cerebral palsy, stroke, multiple sclerosis and related brain disorders.

This all sounds benign enough, although the word “cures” in the name of the center is a huge red flag to me. Longtime readers might remember that about a year ago I wrote about the Marcus Center and Duke University in the context of what it was doing at the time, namely its program, led by Dr. Joanne Kurtzberg, to develop stem cell treatments for autism and its partnership with a quack stem cell clinic in Panama. I’ll repeat one of the Tweets I cited then right here:

At the time, I bemoaned the lack of scientific justification for the program, in which one could easily replace the term “stem cells” with “magic” and leave the verbiage promoting the treatment unchanged in meaning, because, as I like to say, to believers (as opposed to serious stem cell researchers), stem cells are “magic” that can “cure” basically anything. A year before that, I had even written about Duke University’s ethically very dodgy “pay-to-play” clinical trials of stem cell treatments for autism in the context of everything I’ve long known about “autism biomed,” in which autistic children are subjected to unproven treatments and rank quackery in a futile effort to “cure” their autism.

So why am I bringing up Duke University and the Marcus Center again after a year? The other day, Anna Merlan published an exposé of the program entitled A Controversial Autism Treatment Is About to Become a Very Big Business. Remember how often I railed against quack for-profit stem cell clinics before the pandemic shifted most of my writing to be about COVID-19? According to Merlan’s report, it looks as though Duke University, through the Marcus Center for Cellular Cures, is going where every stem cell quack has gone before; everyone, that is, except large universities. It’s going straight into autism stem cell grift of the sort that I normally only referenced in relationship to, for example, antivaxxers like Kent Heckenlively, who once hit up his daughter’s grandparents for $15,000 to take her to a quack stem cell clinic in Costa Rica.

Do you think I’m being unfair? Let’s take a look at Merlan’s reporting:

When desperate parents are looking for medical treatment for their kids, especially their autistic kids, they often do two things: They look up information about a program at Duke University, and then, in short order, they go to GoFundMe. The fundraising site is full of pleas that often mirror one another, in essence saying: My child has one hope, and that hope is in stem cell and cord blood treatments. 

This hope, though, is attached to treatments that are hotly disputed at best, unproven at worst, and often very expensive in either case. At Duke University’s Marcus Center for Cellular Cures, parents can enroll their children into a number of clinical trials that aim to study the effects of cells derived from umbilical cord blood on treating the effects of autism and brain injuries; adults can also participate in a trial testing whether cord blood can help them recover from ischemic strokes. And when parents can’t get their children into any of these clinical trials, particularly for autism, they often opt for what’s called the Expanded Access Program (EAP), in which they pay between $10,000 and $15,000 to get their kids a single infusion. 

As I’ve been saying before, the intent of the Expanded Access Program was never to let investigators charge desperate families big bucks for “experimental” (i.e., unproven at best) treatments like stem cell therapies for autism. Yet that appears to be exactly what Duke University is doing in collaboration with a for-profit stem cell company Cryo-Cell:

Now, a for-profit company called Cryo-Cell International with ties to Duke researchers has indicated that it plans to open clinics promoting these treatments, under a licensing agreement with the renowned North Carolina university. (Cryo-Cell acknowledged receiving a list of questions from Motherboard, but did not respond to any follow-up emails or respond to those questions before publication.) In their investor presentation, Cryo-Cell said they plan to become “an autonomous, vertically integrated cellular therapy company that will treat patients.”

I expect this sort of behavior from for-profit stem cell companies, the vast majority of which market what I consider to be, at best, unproven therapies and at worst rank quackery, all for big bucks, usually $10,000-$20,000 per infusion. You might remember one particularly famous recipient of such treatments whom I wrote about extensively years ago: Detroit Red Wings hockey legend Gordie Howe, who had suffered a major stroke and in 2014 was flown to Tijuana to receive stem cell infusions for his stroke as a marketing ploy by a for-profit stem cell company called Stemedica. It worked spectacularly, with credulous news reports in local and national media, as well as Keith Olbermann promoting the treatment as though it had definitely helped Howe recover neurologic function and attacking me personally for my Tweets and blog posts pointing out how what little information about Howe’s health released by the family did not at all demonstrate that he had recovered significant neurologic function. I do not expect this sort of behavior from faculty at a medical school as prestigious as the Duke University School of Medicine, although in retrospect maybe I shouldn’t have been so naive. If there’s anything the COVID-19 pandemic has taught us, it’s that academic physicians and scientists are apparently no less prone to descending into crankery than any other physicians and scientists.

But back to the Marcus Center and Merlan’s reporting:

Duke and Cryo-Cell’s rush to monetize a procedure before it’s shown to have solid benefits has created concern, though, across the community of scientists, clinicians, and medical ethicists who study autism treatments. 

As well it should. Given the lack of solid science and clinical trial evidence that stem cells do anything for autistic symptoms, as documented by Merlan, myself, and others, coupled with the longstanding history of antivaccine parents subjecting their autistic children to stem cell quackery for big bucks at overseas clinics, this venture is, in my not-so-humble opinion, unethical as hell. (Even Dr. Kurtzberg’s own study showed not even a whiff of a hint of a benefit.) In the context of that background:

This is why Duke’s latest move comes as such a surprise: The university and Cryo-Cell have told investors that they’re planning to open a series of “infusion centers.” At these clinics, Cryo-Cell will use Duke’s technology and methods to offer cord blood treatments for $15,000 per infusion.

In an exuberant presentation for investors, Cryo-Cell said it estimates an annual revenue of $24 million per clinic; it hasn’t disclosed how many clinics it plans to open. At least one will reportedly open in Durham, North Carolina. 

The move follows a June 2020 announcement that Cryo-Cell had entered into an exclusive patent-option agreement with Duke, allowing it to manufacture and sell products based on patents from Dr. Joanne Kurtzberg. 

According to the aforementioned presentation, here are the terms of the deal between Cryo-Cell and Duke:

  • All Regulatory Data And Technical Information Related To 19 FDA Completed And Ongoing Clinical Trials – Includes 6 Completed Phase 2 Trials
  • Rights to Intellectual Property And Proprietary Manufacturing Protocols Related To Cord Blood/Tissue Stem Cells To Treat Neurological Disorders Including Autism, Cerebral Palsy And Traumatic Brain Injuries
  • “Methods for the treatment of autism spectrum disorders,” U.S. Patent No. 10,912,801 was just granted in February, 20211
  • Right To Operate Cord Blood/Tissue Infusion Clinics Under FDA-Approved INDs
  • Rights To Intellectual Property And Proprietary Manufacturing Protocols Related To DUOC1 To Treat Demyelinating Conditions Including Multiple Sclerosis
  • All Rights Are Exclusive And Worldwide With Sublicensing Rights (Excluding Taiwan)
Duke University, Marcus Center, and Cryo-Cell

And what does Duke University get from the deal? Quite a bit if Cryo-Cell manages to make a lot of money:

  • 5.0% of CCEL common stock granted at license execution
  • 2.5% of CCEL common stock upon cumulative net sales of licensed product/process of $10 million
  • 2.5% of CCEL common stock upon cumulative net sales of licensed product/process of $75 million
  • 2.5% of CCEL common stock upon market cap ≥ $300 million provided such trigger occurs by August 23rd, 2022
  • 2.5% of CCEL common stock upon market cap ≥ $500 million provided such trigger occurs by February 23rd, 2023

Wow. So if Cryo-Cell can hit a half billion dollars in sales, Duke University stands to get 15% of its common stock. This would, of course, not be chump change. Indeed, if this joint venture between the Duke University and Cryo-Cell is as successful as Cryo-Cell seems to hope that it will be, few quack stem cell clinics could even approach such numbers. Truly, the grift here is epic, and Duke University is right there, ready to rake it in and over fist if the licensing of the Marcus Center’s intellectual property to Cryo-Cell brings in the big bucks hoped for. It’s not just for neurodevelopment disorders like autism, either, but for pretty much all neurologic conditions, injuries, and diseases, ranging from multiple sclerosis to traumatic brain injuries.

Regular readers know my opinion of this sort of grift, but it’s not just me. Let’s listen to a couple of others:

Alycia Halladay is the chief science officer at the Autism Science Foundation, which seeks to guide families into safe, evidence-based treatments for autism. “While stem cell therapies as medical intervention for the ASD are currently being rigorously studied at Duke, it is still too early to say they actually help those on the spectrum,” she told Motherboard. “Making the move at this time to sell this therapy to families across the world is irresponsible and dangerous. It shocks and surprises me that Duke University, an institution with a stellar academic reputation, would enter into an agreement to sell intellectual property for stem cells in autism, especially since Duke has enormous financial incentive to make this profitable for Cryo-Cell.”

“I was horrified when I first heard about the Duke program,” said Anne Borden King. She’s a Toronto-based science writer and the current chair of the Campaign Against Phony Autism Cures. She also hosts the podcast “Noncompliant,” about neurodiversity, where she’s frequently spoken critically about the Duke program. 

Actually, I might have to disagree with Halladay on one thing. While she is correct that it is too early to say whether stem cell-based treatments help those on the spectrum, I now really don’t think that stem cell therapies for autism are being “rigorously” investigated at Duke University at all. The fact that the Marcus Center and Duke University would pursue an agreement with a dubious for-profit stem cell company to set up clinics to administer its treatments after a completely negative phase II clinical trial tells me that science is not what they are about. They’re about ideology. And the money.

Clearly, Dr. Kurtzberg and other investigators at Duke have come to believe so deeply that the magic stem cells can cure autism—I mean, damn, it’s even in the name of the Marcus Center!—that they’ve become evangelicals for the treatment rather than reasonably objective investigators. (I realize that no one is ever truly “objective,” particularly about a medical treatment that one’s been working on for years, hence the word “reasonably.”) Basically, they appear to have gone from investigators to true believers. As a result, Dr. Kurtzberg is has been  Medical Director for Cryo-Cell International since 2018.

Then there is, of course, the role of the funders, as I described last time. The Marcus whose name is on the Marcus Center turns out to be billionaire Bernie Marcus, cofounder of Home Depot and the company’s first CEO. He is definitely a true believer in stem cell therapies for, well, everything and has been a patient at the Panama stem cell clinic mentioned at the beginning of this article for his chronic bronchiectasis. So has his wife, who has undergone treatment for chronic osteoarthritis at the same clinic. It turns out that Marcus is also very much into alternative medicine and, as a result, has funded centers for “integrative medicine” elsewhere, such as at Thomas Jefferson University.

This brings me back to a point that I’ve made on a number of occasions about “integrative medicine,” which “integrates” rank quackery like acupuncture, naturopathy, chiropractic, and even “energy medicine” into medicine and has resulted in what I like to refer to as quackademic medicine at academic medical centers. The infiltration of pseudoscience into medical academia has been going on at least since the early 1990s, if not longer, and it has now resulted in “integrative medicine,” despite its embrace of quackery, being almost respectable, with a the number of academics who accept it seemingly far larger than the pitiful band of skeptics who try to explain why it’s quackery and pseudoscience being “integrated” into medicine. Whenever I see something like Duke’s partnership with Cryo-Cell to sell stem cell quackery to parents of autistic children for big bucks, I ask: Would this have ever come to pass if the groundwork for accepting pseudoscience in academia had not been laid over several decades in the form of first “complementary and alternative medicine” (CAM) and later “integrative medicine”?

Then consider these questions by Anne Borden King:

The Duke studies raise a troubling question for universities using philanthropic sources of funding: to what extent should universities host and support clinical research programs that attract donor dollars but show little promise of developing safe and efficacious therapeutics? What are the risks of such an approach?

Duke’s capture by a for-profit company like Cryo-Cell to sell unproven stem cell treatments for autism and other neurologic conditions is one risk. As is the misuse of Expanded Access Programs:

Through its Extended Access Program (EAP) Duke invites parents to enroll children who don’t qualify for the study to receive stem cells infusions for a fee of $12,000 per infusion in a separate program. This runs counter to the guidelines of the FDA, which specifies that expanded access only be used for life-threatening conditions where no other treatment is available. In correspondence with parents, the Duke team refer to the EAP as a “compassionate care” program. Duke researchers recruit for the studies through parent-based channels, finding parents to proxy consent for their autistic children to be patients; it is also how EAP participants are identified.

Another risk is harm to autistic children for no possible benefit, at least based on current studies by the Marcus Center and Dr. Kurtzburg, just like any other “autism biomed” treatment:

Through its Extended Access Program (EAP) Duke invites parents to enroll children who don’t qualify for the study to receive stem cells infusions for a fee of $12,000 per infusion in a separate program. This runs counter to the guidelines of the FDA, which specifies that expanded access only be used for life-threatening conditions where no other treatment is available. In correspondence with parents, the Duke team refer to the EAP as a “compassionate care” program. Duke researchers recruit for the studies through parent-based channels, finding parents to proxy consent for their autistic children to be patients; it is also how EAP participants are identified.

Yet another risk is the financial harm to families for no benefit and possible harm to their children:

According to Turner: “The expanded access program at Duke is troubling because parents pay substantial fees for what many of them clearly believe are safe and effective stem cell treatments for autism spectrum disorder.” Turner describes one family reportedly trying to crowdfund $30,000 to pay for the cost of two infusions provided through the expanded access protocol. “Other crowdfunding campaigns also reveal the substantial costs associated with accessing stem cells through Duke’s expanded access program.”

I’ve written more blog posts about patients and families crowdfunding for quackery, including bogus stem cell treatments. I never thought I would be writing about the same sorts of problems with such treatments licensed by a major respected medical school, but there you are. I’ve also been asking this question:

As the years have passed, Turner, Knoepfler, and Snyder have all begun asking the same basic question about the Duke program: Why is an intervention that hasn’t shown much in the way of results not only still operational, but also charging participants a lot of money to get access to it?  

“We can look at their own research,” Turner said. “They haven’t done a convincing job of demonstrating efficacy. So should people have to pay what can end up being substantial amounts of money?” 

Excellent questions, all. The answer is simple: They shouldn’t, but they do. I expect this sort of thing to happen at quack stem cell clinics in, say, Costa Rica, Mexico, or Panama. I do not expect a major university to be in bed with quacks, however. Stem cell biologist Paul Knoepfler was also correct to demand that the FDA investigate Duke’s Expanded Access Program for stem cells for autism, as it appears to violate a number of the provisions of the FDA’s EAP, and its $58 million deal with Cryo-Cell.

Unfortunately, it’s all about the ideology and the grift, and both appear to reign supreme at the Duke University’s Marcus Center for Cellular Cures. In its pursuit of the filthy lucre, Duke University has become indistinguishable from the countless stem cell quacks that I’ve been writing about since 2005.

Don’t believe me? Look here:

Because COVID-19 grift is even more lucrative than autism grift.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

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21 replies on “Quackademic medicine at the Marcus Center for Cellular Cures: Stem cells for autism”

This is appalling on multiple levels. As you point out, it is deeply unethical to charge desperate people for “therapies” that are experimental. And this clearly is still experimental. It throws the costs onto the patients and their families, instead of the companies which stand to gain the most if (and in this case it’s a HUGE “if”) the therapies work out.
It should never have been allowed.

Except that those companies will stand to gain from those “therapies” even it they don’t work out.

“All Rights Are Exclusive And Worldwide With Sublicensing Rights (Excluding Taiwan)”

What did Taiwan ever do to them?

Where do they get the cord blood (eww)? If the parents don’t pay these companies a lot of money to store it then the hospitals just sell it to them without “donor” compensation?

A parent can choose to donate cord blood to a blood bank specifically for research, or for research/treatment. (My friend did this with her baby and they got a “thank you” package that included a super cute onesie that said “saving lives since day 1!”)

and they got a “thank you” package that included a super cute onesie that said “saving lives since day 1!”

Well that does not seem adequate for something that a hit off it is 12-15 large.

Eww eww eww. Eww. There is some major back backbone placenta dealing going on all up in here. Eewww. Squishy entities and their interactions are just gross. Spoiler alert: Rocky is steam powered.

I believe that there may be some enchantment with https://en.wikipedia.org/wiki/Net_present_value

The idea emerges that if these blood pudding baby batter afterbirth spatter blotter corporations looses less for getting caught than making for raping then that is what they will do. Because investors want return. That is why Musk will not make SpaceX public. #fuckjeffwho ,

#shatnerknowethathemaynothaveacouplemoreyearstowaitforrealspacebutdamnsonitiskindofadickrocket

No. Just no. That’s not how stem cells work.
You can’t just infuse them and hope that they’ll traffic to your target organ and then do … something. Only hematopoietic stem cells do that, and that’s because they’re partially differentiated. Everything else just gets cleared out as debris.

Where is Duke’s pre-clinical data? Where are their animal models? Because to jump straight to humans from basic science is not how any of this works.

This is why I don’t want to have anything to do with stem cells, because it seems like for every serious researcher doing science correctly there’s a grifter or quack who wants to hurt people for money. It’s just monstrous.

My favorite recent study involving this was where they compared stem to saline injections in knees and the saline group did better.

Some time ago, after reading one of Dr. Gorski’s articles about stem cells, I found a chiropractic clinic (with one M.D.) selling stem cell injections and sent an email asking about it. I received a call from one of the chiropractors who claimed that the cells would become whatever tissue was needed in the knee: cartilage would re-form in the right places, ligaments would re-grow. When I asked for evidence and studies supporting these claims he became very uncomfortable, asking if I was a Doctor, or worked for the government. (Neither was true, but I had an injured knee.) Their M.D. was the one giving the injections, but his claims that these stem cell injections would regrow everything and give me a brand new knee were ludicrous. As he became increasingly uncomfortable with my questions, and his inability to answer them, he finally said he guessed their treatment was not for me and we ended the call. My only regret is that the authorities don’t charge these practitioners with fraud, and that his concern that I might be an official conducting an investigation was unfounded. Medical and chiropractic boards don’t care. And Yelp pulled my negative review because I wasn’t a patient.

Your only regret is that you got tonsil stones because you are a bad patient. Piss off.

Yeah, my mother in law nearly got talked into one of those clinics. I did a ton of research (with citations!) and wrote a really long email explaining why it wouldn’t work and why it wasn’t safe. Which she completely ignored, because what do I know? (Hello, this is my day job, but thanks.)

Eventually someone talked her friend out of it and that was what finally dissuaded my MIL. Beyond frustrating.

I follow a private FB group called “Stem Cell Therapy for Autism” that pushes both Duke and Panama. Not seeing much about Cryocell (it’s been a few months since I really perused postings there..it’s so depressing seeing parents all excited about “trying to get in” to a Duke study and then being turfed to Panama for the $15K a pop “treatment” there) but I’m sure it won’t be long.

As I read this posting, I started thinking about these quacks figuring out how to do this grift for COVID-19. I was thinking more for Long COVID but it seems likely they’ll fold it into their offerings for the large number of people having prolonged recovery from COVID-19. It’s a perfect set up, too since resolution/improvement of COVID-19 damage does happen (albeit slowly) for a good portion of people who’ve had COVID-19, so you can be sure these grifters will bias their studies to exploit this to claim stems cells “cure” COVID-19 morbidity.

A week or two ago, quack physician Simone Gold of America’s Frontline DogTurds said in at least 2 interviews that AFLD is going to open their own medical clinics with their own physicians. Call me cynical but I can easily see them grabbing onto stem cells as one of their signature scams for their “clinics”

For the experts out there, is there any reason to class autism as a lack of cell development? All I’ve heard about is abnormal synapse organization.

Not exactly.. but I’m sure that they can twist what is known:
— some of the cells in the PFC don’t develop as they should, remaining small
— there are usually EXTRA cells, not less cells, number is determined prenatally
— there are problems with how the cells are arranged in layers in the PFC
— there are problems with cells’ inter-connections in the brain
Researcher Eric Courchesne has videos of his lectures available on the net especially one from Rutgers U.- he’s worked on this since 1980.

Woo promoters can probably say that stem cells can “fix” the underdeveloped cells or even perhaps fix synapses or arrangement -after all, it’s woo, they can say anything.

I’m not a neurologist but I stumbled across this a few years back. Apologies ahead of time for long reply:

Patches of disorganization in the neocortex of children with autism.
AU
Stoner R, Chow ML, Boyle MP, Sunkin SM, Mouton PR, Roy S, Wynshaw-Boris A, Colamarino SA, Lein ES, Courchesne E
SO
N Engl J Med. 2014;370(13):1209.

BACKGROUND: Autism involves early brain overgrowth and dysfunction, which is most strongly evident in the prefrontal cortex. As assessed on pathological analysis, an excess of neurons in the prefrontal cortex among children with autism signals a disturbance in prenatal development and may be concomitant with abnormal cell type and laminar development.
METHODS: To systematically examine neocortical architecture during the early years after the onset of autism, we used RNA in situ hybridization with a panel of layer- and cell-type-specific molecular markers to phenotype cortical microstructure. We assayed markers for neurons and glia, along with genes that have been implicated in the risk of autism, in prefrontal, temporal, and occipital neocortical tissue from postmortem samples obtained from children with autism and unaffected children between the ages of 2 and 15 years.
RESULTS: We observed focal patches of abnormal laminar cytoarchitecture and cortical disorganization of neurons, but not glia, in prefrontal and temporal cortical tissue from 10 of 11 children with autism and from 1 of 11 unaffected children. We observed heterogeneity between cases with respect to cell types that were most abnormal in the patches and the layers that were most affected by the pathological features. No cortical layer was uniformly spared, with the clearest signs of abnormal expression in layers 4 and 5. Three-dimensional reconstruction of layer markers confirmed the focal geometry and size of patches.
CONCLUSIONS: In this small, explorative study, we found focal disruption of cortical laminar architecture in the cortexes of a majority of young children with autism. Our data support a probable dysregulation of layer formation and layer-specific neuronal differentiation at prenatal developmental stages. (Funded by the Simons Foundation and others.).

From a disability right perspective, the “study” is unethical from the get go when it’s based on “curing” autistic people by trying to make them not autistic, instead of focusing on issues that occur within autism to improve the quality of live of autistic people.

I want to claim a sighting but I don’t know what I am looking at. Any suggestions?

Of course there is a big solar storm or something that somebody brought to my attention and meh. I was around in 2003 when I watched my boy scout compass oscillate 15 degrees over 30 minutes and we did not even loose power then. Total hype because Biden is boring. But in taking a look at tickling myself with what I already knew something coherent and very interesting to me popped out.

In this 72 hour loop, at the time of this post, a thin linear-looking object/instrumentation artifact* appears over the top “pole” of the instrument shader (I guess the streaks are cosmic rays and protons and yuck). Within the resolution of the sequence, a spectacular correlation seems to be the the arrival of the CME upon the object and it’s sudden changing aspect ratio to spherical, glinty, yet still changing. The video ends before it is seen if it became a line again. Like if the wind put it into a mild spin? Anybody got a clue on what else could be out there? Telescope is at some Lagrange point.

https://sohowww.nascom.nasa.gov/data/LATEST/current_c2.gif

*Because that is a black box to me and I can’t grok how the side away from the Sol is illuminated.

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