It all started with a concerned mother, a stem cell cure for autism was promoted which she did not entirely trust. Especially since the recruitment officer is an antivaxxer, and several other associates of the company’s founder not being kosher either. The mother wrote to me, I wrote to Smut Clyde. Smut Clyde wrote this post.
A clinical trial NCT02168868 was registered in 2014 and is still listed as “recruiting”. Its sponsor is the Israeli company Cell-El, founded by Benjamin Gesundheit, formerly paediatric oncologist at the Hospital for Sick Children in Toronto Canada.
The trial seeks to recruit 450 children with Autism Spectrum Disorder (ASD) plus some controls, the trial site is the private hospital Shaare Zedek Medical Center in Jerusalem; a professor of the Hebrew University, David Naor, is one of the principal investigators. The trial seeks to prove some predefined autism “biomarkers”, specifically maternal antibodies in autistic children’s bodies. Therefore, the clinical intervention is described as urine and stool sample collection, and mainly blood draws:
“Diagnostic Test: Blood Draw
For children who had recently undergone ASD-directed treatment (≤60 days), a single blood sample (5 mL) will be collected at three independent visits, conducted at 2-month intervals.”
But what is that “ASD-directed treatment”? I wrote to Gesundheit, Naor and other Cell-El investigators, asking if it’s “the stem cell treatment your company Cell El offers”, which is described and even illustrated on the company’s website:
Gesundheit eventually replied, telling me:
“Please see my website below where you ll find also info about our research and publications. “
I wrote back:
“I understand from your reply that the “ASD-directed treatment (≤60 days),” in NCT02168868 is indeed the stem cell therapy described here: https://www.cell-el.com/therapy/ Thank you very much. Please confirm, and tell me if you are willing to answer some additional questions…”
Gesundheit replied with:
“Correct! Happy to discuss some questions with you!“
Correct then, so it’s stem cell therapy, never registered as a clinical trial as it happens. Only the blood draws are registered and approved by Israeli Ministry of Health. And the stem cell treatment?
The bone marrow cell extraction and re-injection into the spinal column (which is painful and extremely dangerous) are even being advertised as a part of blood biomarker clinical trial package in Israeli news (from May 2021):
“Optimal dosage, ideal age for treatment, and number and timing of treatments remain open questions for our clinical research. We do know that younger children are more responsive to immuno-modulation.”
It may also be possible to look for immunological biomarkers in the blood of mothers of autistic children and treat the mother before further pregnancies. “If we can do prevention that would be totally incredible,” says Gesundheit. […]
Gesundheit also heads a startup called Rapo Yerapeh that’s investigating the use of oncolytic viruses to treat metastatic tumors, and he is researching an existing antiviral as a treatment for Covid-19.”
So many business opportunities, stem cell therapies for autistic children, their mothers, plus cancer cures as a bonus. I sent Gesundheit my questions, and this is where our exchange went dead. Update 18.11.2021: Gesundheit replied now, my questions and his replies are at the very end of this article. Turns out, due to lack of ethics approval in Israel, families travel to a secret place abroad to pay for a “stem cell” therapy, with what Gesundheit described as “magnificant results” (sic). These children are then analysed for blood biomarkers, this part of the clinical trial is paid by Cell-El.
Now, this is where you must meet Cell-El’s Recruitment Coordinator, Leah Hochbaum. What a character. So much antivaxxery in her Facebook feed, and the best bit: the letters “רפא” in her profile picture. This stands for a certain Avni, and you sure want to know who this Avni is? As Times of Israel summed up, under the headline:
“COVID-denying antivaxxer doctor permanently loses medical license “
“Arieh Avni, who recently said ‘anyone who administers a vaccine is, to me, like Mengele,’ has reportedly forged immunization certificates and mask exemptions for pay”
Gesundheit remain silent and had no comments on that idol of Hochbaum’s. Amazing how autism quackery goes hand-in-hand with antivaxxery.
Gesundheit said about Hochbaum’s antivax activities:
“I don’t share her attitude nor does the literature support it (as I clearly state in my publications), but I remain tolerant and respectful for parents and everybody with other opinions.“
Mouse models are meaningless. You can use mouse models to prove anything that’s even remotely true
By Smut Clyde
Too much time spent conducting ethnography among the Tribe of Autism Grifters taught me that their time-honoured folkways include a tradition of using stem cells to reverse autism, thereby re-uniting parents with the normal child that the fairy folk had abducted and replaced with a changeling. Readers may recall Kent Heckenlively, Judy Mikovits‘ co-author on “Plandemic“.
After chelation failed to drive the mercury out of his daughter’s body, Heckenlively decided that the Stem-Cell Cure would accomplish that task, and took her to Costa Rica (or maybe it was Panama, or Tijuana… it is hard to keep all the clinics apart). Despite initially promising signs, the cure ran out and he was forced to cure her some more with phenylbutyrate, keto diet, bleach enemas et cetera.
The stem-cell trough is so popular that we can only sample a few of the names that crowd around it. You should also recall Dario Siniscalco, Nicola Antonucci and Jeff Bradstreet from an earlier airing of my obsessions.
All three appeared together in a regrettable bolus of bafflegab.
Dario Siniscalco, James Jeffrey Bradstreet, and Nicola Antonucci Therapeutic Role of Hematopoietic Stem Cells in Autism Spectrum Disorder-Related Inflammation Frontiers in Immunology (2013) doi: 10.3389/fimmu.2013.00140
Antonucci and Siniscalco set up their own “child-trafficking” Underground Railway from Italy to Ukraine, to supply ‘EmCell’ there with a steady flow of customers. Jeff Bradstreet was another exponent of Ukrainian stem-cell quackery before moving on to the GcMAF fraud. Together or in pairs they collaborated directly with the Ukrainian medscammers with the noble goal of subsidising predatory journals.
- Siniscalco, Sapone, Cirillo, Giordano, Maione & Antonucci Autism Spectrum Disorders: Is Mesenchymal Stem Cell Personalized Therapy the Future? BioMed Res Int (2012) doi: 10.1155/2012/480289
- Siniscalco, Bradstreet, Sych & Antonucci Perspectives on the Use of Stem Cells for Autism Treatment Stem Cells Int (2013) doi: 10.1155/2013/262438
- Siniscalco D, Bradstreet JJ, Sych N, Antonucci N. Mesenchymal stem cells in treating autism: Novel insights. World J Stem Cells (2014) DOI: 10.4252/wjsc.v6.i2.173
- Bradstreet, Sych, Antonucci, Klunnik, Ivankova, Matyashchuk, Demchuk & Siniscalco, Efficacy of Fetal Stem Cell Transplantation in Autism Spectrum Disorders: An Open-Labeled Pilot Study, Cell Transplantation (2014) doi: 10.3727/096368914X684916
- Siniscalco, Kannan, Semprún-Hernández, Eshraghi, Brigida & Antonucci, Stem cell therapy in autism: Recent insights, Stem Cells & Cloning (2018) DOI https://doi.org/10.2147/SCCAA.S155410
- Freye, Behaviorally associated changes in neuroconnectivity following autologous umbilical cord blood infusion in young children with autism spectrum disorder, Ann Transl Med. (2019) doi: 10.21037/atm.2019.05.55
It is not clear why mesenchymal stem cells (nor any other kind) – filtered out of liposuctioned fat, or harvested from bone marrow – will rebuild the donor’s arrangement of neurons when drip-fed back into that person’s bloodstream or cerebrospinal fluid. Sometimes they are claimed to reduce neuroinflammation somehow, but it is all hand-waving and Worship Words like ‘immunomodulation’, and the simple answer is that Stem Cells are Magic.
The allure of these stem-cell-shaped magic beans is so enthralling that when “the largest clinical trial of the therapy’s effectiveness” showed no benefit, researchers at Duke University simply decided that they were trialling wrong. They scoured their data for a subset of subjects who did seem to improve, began recruiting subjects for new, larger trials, and went on promoting medscam tourism on behalf of their supporters. Stem cells cannot fail, they can only be failed.
Earlier I forgot to mention this Duke University research, conducted in partnership with or as an extension of stem-cell entrepreneurs Cryo-Cell. Families were charged $US15,000 to participate in the ‘Expanded Access Program’ [for compassionate use], which is where guinea-pigs pay to be subjected to experiments. Perhaps the University was inspired by cancer-cure fraudster Burzynski, and the legal loophole he uses to sell worthless placebos to dying victims (by pretending to enroll them in ‘clinical trials’ that are never published).
[Btw, Duke cord blood technology is presently being deployed in Israel, celebrated by the quack churnalists of Jerusalem Post: “Dr. Omer Bar Yosef, a clinical and research neurobiologist at Sheba Medical Center, Tel Hashomer, has thus far treated 25 children with autism as part of a Phase II trial using a protocol developed at Duke University Medical Center.” -LS]
Paul Knoepfler, Orac and others have covered the Duke abomination already, at enough length to leave me with nothing to add, so instead let’s look at a smaller manifestation of the same phenomenon – where Stem-cell Sorcery joins forces with the medical marketplace – at Cell-El in Israel. “Is there any reason”, you ask, “why we should care about the flaky theories and questionable practices of a small biomed company?” True, they are not our problem, and Cell-El has a low profile outside of Israel, but a few broader principles are illustrated.
The story begins with a 2014 Clinical Trial registration (NCT02168868), retrospectively regularising a trial that began in 2013, to look for Autism Biomarkers in blood and stool samples.
Behavioral testing is the gold standard for diagnosing ASD. These tests, including ADOS and ADI-R are subjective, require trained staff to administer, are time-consuming, and can only be administered at a later age.* Blood-, urine- or stool-based diagnostic biomarker test for ASD would enable objective early diagnosis, potentially even before clinical symptoms are present, hence early behavioral intervention, and potentially eliminating the need for trained staff. Ideally, such a test would not only conserve money and time but would also provide clues to ASD pathogenesis.
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Autism Biomarkers are another autism-research obsession, like the Questing Beast of Arthurian legends. The Sir Pellinores in tireless pursuit (carrying hatfuls of fewmets to guide them in their quest) agree that these will be more objective, and therefore more accurate, than the socio-behavioural-observation tools in current practice. It may be a problem that ‘autism’ is defined by social behaviours, rather than by blood chemistry… if biomarkers are superior, we’re faced with the ‘Minority Report’ scenario of people being diagnosed with autism despite perfectly neurotypical self-report and social interactions… or infants being fast-tracked into behavioural or biomedical treatments because blood tests determined a risk that they might otherwise grow up weird. Autism advocates are wary of the Biomarking ignis fatuus, as only one step away from stigma and medicalising. The concept has one advantage, though, as it allows me to interpret ‘biomarkers’ as a behavioural marker for mountebanks.
- Bradstreet, Vogelaaar & Thyer, Initial Observations of Elevated Alpha-N-Acetylgalactosaminidase Activity Associated with Autism and Observed Reductions from GC Protein—Macrophage Activating Factor Injections, Autism Insights (2012) DOI: 10.4137/AUI.S10485
- Bradstreet, Pacini & Ruggiero, A new methodology of viewing extra-axial fluid and cortical abnormalities in children with autism via transcranial ultrasonography, Frontiers in Human Neuroscience (2014) doi: 10.3389/fnhum.2013.00934
- Frye, Vassall, Kaur, Lewis, Karim & Rossignol, Emerging biomarkers in autism spectrum disorder: a systematic review Ann Transl Med. (2019) doi: 10.21037/atm.2019.11.53
- Ansel, Posen, Ellis, Deutsch, Zisman & Gesundheit, Biomarkers for Autism Spectrum Disorders (ASD): A Meta-analysis Rambam Maimonides Med J. (2019) doi: 10.5041/RMMJ.10375
Thus the inducements for parents to join this 2013/2014 trial included the prospect of early diagnoses and treatment. Not so much for the subjects themselves, who’d presumably received a diagnosis already, but for younger siblings. I note in passing that the trial protocol excluded children who’d undergone treatment more than 60 days previously; if an intervention was more recent, the protocol called for three blood draws instead of one (perhaps so that any improvement in the prospective markers could be tracked). This criterion might cause some to speculate that the trial sponsors were intending to offer their own treatment as well as the blood tests, but I am less cynical, and see it as an acceptance that parents are sometimes sucked in by charlatans.
So what are we to make of the seven-year delay in the publication of results, pushed back to December 2022? It is a significant period, inspired perhaps by the seven years of initiation spent by Hans Castorp at a Swiss mountain-top sanatorium in ‘The Magic Mountain‘. It is also a long time to wait for early diagnosis.
Even as the Cell-El website now solicits new recruits for the extended experiment, it offers the actual test, with actual results, as if the sought-after combination of markers has been confirmed and validated. The researchers want to have their cake and eat it even before they’ve settled on the recipe. I hope there is no charge for joining the trial.
To be fair, the seven-year delay has not been wasted. Drs Gesundheit and Rosenzweig have another biomed start-up to occupy their time: GoViral, a subsidiary of Rapo Yerapeh Ltd, seeking to cure cancer with oncolytic viruses. There is a 2017 Frontiers Special Issue / E-book for support. Some cynicism about oncolytic viruses is unavoidable after a competing product ‘Rigvir’ was licensed in Latvia to treat melanoma (with marketing through Frontiers), only to lose its license again in 2019 because it’s total quackery that somehow survived from the Soviet era.
Despite Rigvir, not all oncolytic-virus research is scammy; it’s a long-shot approach but not absurd. I mention GoViral mainly because some of its dramatis personae serve to foreshadow the Cell-El staff (when I get that far), and because Dr David Naor – a poster-boy for Israel’s medpharm sector for curing Multiple Sclerosis (MS), Alzheimers and cancer – is also a co-author on a Cell-El foundational document.
In fact there are five Cell-El foundational documents, setting out the company’s vision. I will go through them without concern for chronological sequence, but starting in 2013 with “Immunological and autoimmune considerations of Autism Spectrum Disorders“, whose authors include Gesundheit, Rosenzweig and Naor, but also Gideon Koren** [whom Gesundheit must have befriended while at SickKids Hospital in Canada, -LS].
Benjamin Gesundheit, Joshua P. Rosenzweig, David Naor, Bernard Lerer, Ditza A. Zachor, Vaclav Procházka, Michal Melamed, Donald A. Kristt, Abraham Steinberg, Cory Shulman, Paul Hwangi, Gideon Koren, Asnat Walfisch, Jacob R. Passweg, John A. Snowden, Ryad Tamouza, Marion Leboyer, Dominique Farge-Bancel, Paul Ashwood Immunological and autoimmune considerations of Autism Spectrum Disorders J Autoimmunity (2013) doi: 10.1016/j.jaut.2013.05.005
The text is a window into the biomedical milieu from whence it came, and there is a mouse model! (I’ll come back to that). You might conclude from the title and the choice of Journal of Autoimmunity as publication vehicle that the emphasis is on autoimmunity, but it’s more a case of maternal antibodies, with a head-nod to the paramount role of genetics, and a lot of tergiversation without saying anything definite.
A later slideshow revisited that vision in bullet-point form to target potential investors. As of 2018, biomarker diagnosis was still only an aspiration. Autoimmunity-by-proxy was still the etiology of choice, with maternal antibodies crossing the placenta and impacting fetal development. It’s not an egregiously stupid theory, is all one can say, except for the absence of the father, when one of the few established facts in the field is that paternal genetics (and age) are as important as maternal ones.
The slideshow cites a 2017 Frontiers Special Topic, “Autism Spectrum Disorders (ASD) – searching for the biological basis for behavioral symptoms and new therapeutic targets“. Topical Special Issues are a growing feature of contemporary academic publishing. You approach the journal with a suggested topic, you recruit the contributors and edit their submissions, you receive a slice of their publication payments. Springer, for instance, continue to fall for completely bogus Special Issue proposals, not to forget Taylor & Francis, though it isn’t clear how these differ from supposedly legitimate ones. They’re central to the MDPI growth strategy. Frontiers were early adopters of the Multilevel-Marketing concept, and now they’re rebranding the results as E-Books (unless they wish a Special Issue into the cornfield when the benefits accruing from it are less than expected).
So Gesundheit and Rosenzweig handled the submissions and contributed a few pieces of their own, setting out their paradigm again. Yehuda Shoenfeld (another familiar name!) was third co-editor, though it’s difficult to see what he contributed other than the cachet of his name. Other papers are far-removed from the Cell-El research program (“Autism as a Disorder of High Intelligence“?!) Frye et al. went off on tangents about heavy metals and mitochondrial disorders.
This sporadic irrelevance did not stop the creator of the 2018 slideshow from listing the 50-odd authors as “Cell-El’s International Collaboration of Experts”. THIS IS BULLSHIT, bordering on fraud if presented to investors. Were the Frontiers contributors aware, when they submitted their manuscripts, that they were handing over their names to become part of an investment pitch?
Many of the slides from 2018 were recycled in a 2019 slideshow delivered to the Israeli Society for Child Development and Rehabilitation, “Autism Spectrum Disorders and Stem Cell Therapies: A Promising New Direction” – a fourth foundational document. In addition we learn that Gesundheit and Rosenzweig had succumbed to the siren song and are keen to cure autism with stem cells.
For some reason the improvement of their N=2 cases was measured with parental-report questionnaires (rather than with the “gold standards” ADOS and ADI-R). ATEC and SCQ are rubbish, alas, unless you’re trying to measure a placebo effect, so they’re popular with autism grifters.
The accompanying illustrations project a mood of serenity and relaxation; one imagines the soothing background music. The reality of bone-marrow stem-cell harvesting is having a large nail hammered into your hipbone. Sedation and local anesthetic do not make it any more fun. Bone-marrow donors endure this voluntarily but they are saints. It’s unclear why separating out the putative stem-cells and infusing them back into the bloodstream should inspire them to behave any differently from their function in the marrow, i.e. making more bloodstream.
“IT administration” means “intrathecal” – a needle goes through the disks of your lumbar vertebrae, and through the dura mater, into the protective fluid around your spinal cord. This is equal parts terrifying and useless. Terrifying because there is so much that can go wrong with a lumbar puncture, even a mere spinal tap; useless, because the CSF is not a culture medium. Stem cells injected into your CSF will not survive: this is not brain surgery, people! OK, perhaps it is.
“There are no words to describe how appalling I find that.”
Orac (2008)
Speaking of “things that can go wrong” when stem cells meet spine: DO NOT use your own nasal mucosal tissue to pack gaps in your spine, even if all the other kids are doing it. Sometimes the transplants survive, but rather than making more neurons as hoped, the stem cells simply make nasal-mucous tumors.
In fact Gesundheit and Rosenzweig were already Stem-Cell-Curious back in 2015 (so perhaps that “recent intervention” eligibility option in the 2014 clinical-trial registration was added with their own treatment in mind, after all).
Gesundheit, Ashwood, Keating, Naor, Melamed & Rosenzweig, Therapeutic properties of mesenchymal stem cells for autism spectrum disorders, Medical Hypotheses (2015) doi: 10.1016/j.mehy.2014.12.016
is all flim-flam and magical thinking with a side-order of “all these other cool kids are curing stuff with stem cells so we should too“. To avoid disappointment, this fifth document was published in Medical Hypotheses, which is a warning not to expect a Bakedness score > 0.5 on Good’s scale of Partly-Baked Ideas.
The successful implementation of this brainfart appears as established fact on a ‘Therapy’ tab at the Cell-El website, with the news that “Cell-El plans to launch a therapeutic study” [no clinical trial is registered], and an invitation for concerned parents to sign up. Will there be a price-tag? Inquiries continue.
If anyone needs another reason to walk (do not run) away from Cell-El and its clinical trials, there is the company’s Recruitment Coordinator. Leah Hochbaum has prior form as an antivax conspiracist.
* * * * * * * * * * * * * * * * * * * *
Back to those broader principles, as promised. First, mouse models. To repeat: autism is a social-behaviour phenomenon, especially language. Clearly mice do not have language, nor Theory of Mind, nor much in the way of a complex society, and when two mice meet it is hard to tell how well they are each picking up the other’s emotional cues. For researchers this creates a golden opportunity to damage mice in diverse ways, confident in the knowledge that when their murine functionality is impaired enough, there will always be some deficit that can be redefined as ‘autism’.
For Mady Hornig with the notorious “Rain mouse” study, it was convenient to operationalise “autism” as “obsessive repetitions”… specifically, obsessive grooming, to the point of self-mutilation. In fact she was measuring parasthesias, having poisoned susceptible mice with enough organic mercury to damage their nerve endings so that their paws and tails were numb and constantly tingling. But the results fitted the narrative of “Thimerosal in vaccines causes autism”, as sought by the antivax sponsors of the study, so no-one looked too closely at
Hornig, Chian & Lipkin, Neurotoxic effects of postnatal thimerosal are mouse strain dependent, Molecular Psychiatry (2004) DOI: 10.1038/sj.mp.4001529
For Robert Naviaux, taking a break from researching the health benefits of dark chocolate, the way to make mice autistic is to reset their purinergic intra-cellular signalling channels by stressing them in utero with a poly(IC)-RNA simulated viral infection administered to the dams. You knew that already, didn’t you?
Robert K Naviaux , Zarazuela Zolkipli, Lin Wang, Tomohiro Nakayama, Jane C Naviaux, Thuy P Le, Michael A Schuchbauer, Mihael Rogac, Qingbo Tang, Laura L Dugan, Susan B Powell Antipurinergic therapy corrects the autism-like features in the poly(IC) mouse model PLoS One (2013) doi: 10.1371/journal.pone.0057380
The pups, when grown, displayed a wide range of symptoms: general muscular weakness, neural deficits, metabolic dysfunction. Unsurprisingly, they failed the rotating pole-dance test, which is to say they were clumsy, which for Naviaux became the defining characteristic of autism.
In the Social Preference test, Naviaux’ mice were also more interested in a cage containing Lego blocks than in another cage containing a conspecific. I am open to the possibility that the treatment had radically transformed their intelligence, so their fascination with the Lego blocks lay in the potential for assembling them into a ramp and escaping from the mouse enclosure and then world domination.
The Rule of Three demands a third instance. An obvious choice is the popular Valproic-Acid Model.
“the rats had short attention spans/short memories and got confused in the star shaped maze… the Japanese researchers had created a rat model of Attention Deficit Disorder.”
Anonymous (2005)
This is inspired by observations of a sensory-cognitive condition, in humans exposed in utero to sodium valproate (Epilim), that can share features with classical autism. But that is too easy; also the model was partly responsible for the existence of Frontiers, founded by Kamila and Henry Markram as somewhere willing to publish their “Intense World” Grand Unified Theory of Autism, and we don’t want to annoy the Frontiers management.
So instead I give you the Christopher Shaw / Christopher Exley / Romain Gherardi network, for whom aluminium-salt adjuvants in Hep-B and HPV vaccines are the real cause of autism. This group define “autism” as shyness and caution, as evinced by the test mice when they spend less time exploring the open centre of their enclosure. Unless they spend more time than control mice exploring the centre of their enclosure, in which case attention shifts to the loss of their protective aversion.
These are all examples of the general research principle that when you lose your keys in a dark alley you should search for them around the corner where there’s more light under the streetlamp. Gesundheit and Rosenzweig picked the “maternal antibody” model which creates mice with pervasive developmental disorder autism by exposing them in utero to particular human antibodies.
Daniel Braunschweig, Mari S. Golub, Claire M. Koenig, Lihong Qi, Isaac N. Pessah, Judy Van de Water, and Robert F. Berman Maternal autism-associated IgG antibodies delay development and produce anxiety in a mouse gestational transfer model J Neuroimmunol. (2012) doi: 10.1016/j.jneuroim.2012.08.002
* * * * * * * * * * * * * * * * * * * *
Second, we met the spectacle of bioscience start-up companies buying papers in Open-Access journals for commercial use, to dress up their marketing flimflam in a mantle of academic authority. The journals need not be at the predatory / parasitical end of the publishing spectrum (though it is a mistake to think that everyone who publishes in a ‘predatory journal’ was beguiled by false promises of academic rigor and broad readership; often they know perfectly well that they’re paying for sciency lipstick on a press-release pig). This phenomenon is something to bear in mind when a company’s website showcases papers in (for instance) Frontiers journals, as if these indicate mainstream acceptance of the directors’ discoveries.
Here’s another example. The ‘RESEARCH’ tab at the ATGesundheit Institute website provides a Frontiers Special Topic on “Genetically Engineering the Future of Cancer Therapy“. Also papers in a garbage “Oncology Case Reports Journal“, from Remedy Publications (a random gang of Hyderabad grifters). No, my bad, the ATGesundheit Institute is another incarnation of Rapo Yerape BH Ltd, i.e. GoViral, i.e. Dr Beni Gesundheit again:
“The ATGesundheit Institute website presents information about oncolytic virus (OV) cancer immunotherapy for glioblastoma multiforme (GBM), solid tumors and breast cancer. Our website is dedicated to exploring the therapeutic potential of OVs for incurable tumors and the therapeutic mechanisms of various OVs.“
There is no pretence of “clinical trials” here. The Institute is a front-end for a Bavarian clinic and a Swedish-born Bavaria-based medical maverick who cures cancer with hyperthermia and oncolytic viruses (again). Gesundheit acts as concierge, not quite crossing the legal border of “offering treatment”, while grooming potential patients for referral to Arno Thaller or Karl Aigner‘s Medias Klinikum. Neither of these are as famous as (e.g.) the Hallwang Private Oncology Cash-Extraction Clinic, but we still find the former listed on ‘Suppressed Cancer Breakthrough’ conspiracy sites. Germany and Switzerland are traditionally safe havens for all manner of AltMed adventures if they are presented as Cutting-Edge experimental work, using the Individueller Heilversuch (compassionate use) loophole. The ATGesundheit Institute invites:
“You can sign up for our consultation services (the “Consultation Services”) in connection to your disease by means of our Site. Once we receive your request, we will provide you with a health questionnaire and review your answers in order to determine eligibility (“Eligibility” or “Eligible”) for referral to a licensed medical professional for purposes of receipt of certain treatments.“
This is arguably relevant to the question of how far to trust the Cell-El stem-cell treatment for autism, but I am wandering rather far from the broader lessons, so I’ll stop now.
* * * * * * * * * * * * * * * * * * * *
* RIP Michael Rutter, whose contributions to the rigor and objectivity of the ADOS and ADI-R are not sufficiently appreciated.
** Koren, of course, made a good career in Canadian academia through his Motherisk program (providing bogus evidence of cocaine abuse that separated mothers from families) and by offering garbage opinions on which painkillers could be entrusted to mothers. This was before he fled Toronto trailing lawsuits and retractions, to start afresh as a Professor in a department named after a Trump-financing casino tycoon, at an unrecognised “university” with an ethnic-cleansed campus.
Update 18.11.2021
Gesundheit replied to my questions now, he seems not to have clicked on the link to For Better Science and not searched there for his collaborators Shoenfeld and Koren as I advised. Below my questions (LS) and his replies (BG, in italic).
LS: Now that it is clarified what the described “ASD-directed treatment” is, namely the stem cell treatment described on Cell-El website, here my questions.
Why is the trial registered for blood draws only, but not for the main intervention “ASD-directed treatment of stem cell extraction and injection?
BG: “I just could not yet get approvals in Israel to treat – MoH and Ethics boards . However, we analyze our Cell El biomarker on ASD children (treated elsewhere) and got fascinating preliminary results confirming our working hypothesis. Let’s hope with more of these great results on the diagnostic biomarkers (D) we can move forward with the therapeutic trial (T) to help these children (= “from D to T”).
LS: Are there any financial costs to patients and their family in participating? Who finances these trials?
BG: “Not for D, patients who wish to get treatment abroad have to pay them for the T but we cover our blood draws pre- & post treatment. “
LS: How many patients have you treated already, and what kind of success did you observe?
BG: “too early to report – it’s in progress! Working on these magnificant results!“
LS: Your recruiter Leah Hochbaum shared vaccine misinformation on social media. Did you know, and do you have a comment on that?
BG: “Of course I know, she is a very dedicated mother of a ASD child and many parents mistakenly accuse the vaccination. She is very helpful to recruit children and sensitive to parents of ASD children! I don’t share her attitude nor does the literature support it (as I clearly state in my publications), but I remain tolerant and respectful for parents and everybody with other opinions…. “
I now asked where abroad and in which clinics those “stem cell” therapies are performed, but Gesundheit evaded due to not having a “full scientific clinical collaboration in place“, only mentioning:
“We reviewed the children treated in both clinics, saw good clinical results (not in all children) and collected their data in order to compare these 2 approaches (I published on both approaches in 2013!)”
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But how is all this even supposed to work? They are all stupid with no understanding of biology or just greedy crooks? (Talking about the doctors not the patients).
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“They are all stupid with no understanding of biology or just greedy crooks?”
Why not both?
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Maybe I should explain the main difference between this trial by Cell-El and the Duke University trials. While the latter was just pointless and useless, the former is extremely dangerous.
Duke researchers used commercial cord blood bank cells and injected them intravenously.
https://www.jpeds.com/article/S0022-3476(20)30334-6/fulltext
Cells quickly died, kids barely suffered.
Gesundheit et al want to subject children to extremely painful bone marrow extraction procedure, and then inject those cells onto their spinal columns. As Smut Clyde explained, this is dangerous and scary. So much can go wrong.
I would be very surprised if any Israeli public authority issued an approval for that.
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Thanks for the explanation. That feels very bad indeed
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The relationship is modest, though, and the evidence only observational; it would be unethical to conduct clinical trials in which developing fetuses were deprived of vitamin D.
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