Unethical “Stem Cell” Therapy for Autism In India?

By Neuroskeptic | March 17, 2017 4:29 pm

I just read a concerning paper about an experimental stem cell treatment for children with autism.

Untitled

The authors are Himanshu Bansal and colleagues of India. The senior author, Prasad S Koka, is the Editor-in-Chief of the Journal of Stem Cells where the paper appeared, which raises questions about whether the manuscript received a thorough peer review. Koka is actually an author on all five of the research papers published in that issue of the journal. But that’s a minor issue compared to the content of the paper.

Bansal et al. describe a procedure in which they extracted fluid from the bone marrow of each child. This fluid (bone marrow aspirate) was treated in the laboratory to purify the stem cells within, and then injected into the child’s spinal canal. The whole operation took place under general anaesthesia. 10 autistic children aged 4-12 were treated.

I found this pretty shocking. An invasive procedure involving general anaesthesia should only be performed if it’s medically justified – especially in children as young as 4! Bansal et al. provide no scientific explanation for why they thought this treatment was suitable for these patients. They vaguely name “immunological and neural dysregulation” believed to underlie autism as the target of the cells.

For what it’s worth, the results showed a slight improvement in autism symptoms after the treatment. However, there was no control group, so placebo effects are likely, and we’re told that the patients were also given “speech therapy, occupational therapy and psychological intervention” which might account for the benefits.

So who gave the green light to this project? Well, remarkably, Bansal et al.’s paper contains no information about which ethics committee reviewed and approved the study. I don’t know about the laws in India, but in the UK or the USA, conducting even the most benign research without the proper ethical approval is serious misconduct. Most journals absolutely won’t publish medical research without an ethics statement.

The paper also contains no mention of conflicts of interest – another thing that most medical journals require. I believe that financial conflicts of interest are likely to exist in this case because Bansal gives his affiliations as Mother Cell, his own private venture, and RegennMed, who sell various stem cell treatments.

regennmed

Overall, to say that this paper is ethically questionable is an understatement, and it would have been rejected by any real journal.

This isn’t Dr Himanshu Bansal’s first foray into the amazing world of dodgy stem-cells. He briefly made headlines around the globe last year when he announced his “ReAnima” project to bring a brain dead woman back to life (with stem cells). Indian authorities eventually blocked his resurrection attempt. There’s some more interesting dirt on Bansal on this forum.

This is also not the world’s first stem cells for autism trial. For example, Duke University launched a $40 million trial in 2014. The treatment in that trial was a blood infusion, so it was pretty non-invasive: no bone marrow, spinal needles, or general anaesthesia. However, critics argue that it’s pure speculation to think that stem cells would help in autism. Then again, the same could be said about a great many “stem cell” therapies.

ResearchBlogging.orgBansal H, Verma P, Agrawal A, Leon J, Sundell IB, Koka PS. (2016). A Short Study Report on Bone Marrow Aspirate Concentrate Cell Therapy in Ten South Asian Indian Patients with Autism Journal of Stem Cells, 11 (1)

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  • Leonid Schneider

    If these patients were real, the authors would be in an Indian prison now, facing the court trial of the year, or maybe the decade.
    Therefore, I presume this and other papers by Koka in his own predatory journal are works of fiction, and no real patients were harmed in the making up of these papers.
    Why is this joke journal actually listed on PubMed?

    • Catherina

      ask Pubmed?

      • http://blogs.discovermagazine.com/neuroskeptic/ Neuroskeptic

        I think Leonid has sent them a message! And I hope they have a good answer because this journal shouldn’t be indexed there in my view.

    • smut clyde

      Koka in his own predatory journal

      It’s not his only predatory journal — Koka is also Editor-in-Chief of “Stem Cell Biology and Research” from the mockademic publisher “Herbert”.

    • http://blogs.discovermagazine.com/neuroskeptic/ Neuroskeptic

      It’s possible that the study was just made up. But if you were going to make up a trial, wouldn’t you make up a control group? And more than 10 patients…?

      • https://forbetterscience.wordpress.com Leonid Schneider

        if Koka and Bonsal were that clever, they would have invented something less ridiculous and dangerous science-wise, and then publish it in a proper journal. Please, I don’t want to be wrong here, the alternative with paralysed child patients is too scary. If an Indian citizen reads this, please report those people to the police and other authorities!

    • smut clyde

      I am not at all sanguine about the idea that the Indian regulatory regime is sufficiently robust that Bansal would be arrested if this “research” really occurred. He’s a complete scammer, but clearly he is making a living from his multiple fake clinics, and has access to patients to experiment on (he has a special interest in charitable indigent cases).

      Back in 2004-2007, Prasad Koka was actually receiving big money in NIH grants through the Torrey Pines Institute for
      Molecular Studies, to research “Role of c-Mpl in HIV-1
      Induced Cytopenias”:
      http://grantome.com/grant/NIH/R01-HL079846-03
      That involved playing with lab mice rather than with humans, but it is possible that Koka’s successful conmanship left him with a taste for lab-coat dress-up games.

      The NIH $$$$ did result in a few papers, not all published in Koka’s own predatory journals. There was this one, for instance, published in a Bentham journal: “Thrombocytopenia in HIV infection: impairment of platelet formation and loss correlates with increased c-Mpl and ligand thrombopoietin expression”, and co-authored with Birgitta Sundell. Sundell being the middle author, with the Wayne State University Anthropology affiliation, in this present series of press releases.

  • smut clyde

    The authors are Himanshu Bansal and colleagues of India.
    The J.Leon who recurs across the papers is from “Advanced Health Institute, Puerto Rico” (does Puerto Rico enjoy a similar status to Tijuana in terms of attracting quacks and scammers?), and someone from the
    Department of Anthropology (Wayne State University), whose involvement in medical studies is not entirely clear

  • smut clyde

    Koka is actually an author on all five of the research papers published in that issue of the journal.

    There is also the Editorial by Bansal, “Autologous Bone Marrow Transplantations in Neurological Disorders“, where he takes the opportunity to fabricate a long list of completely fraudulent affiliations.

    1 Fellow Micro Surgery, Osaka (Japan), London (UK).
    2 Fellow Spine Surgery, Aarhus (Denmark).
    3 Fellow Traumatology, Wuzburg (Germany).
    4 Research Fellow Spinal Cord Injury, Miami (USA), Lisbon (Portugal), Brescia (Italy).
    5 Fellow Stem Cell Research, Glasgow (UK), Prague (Czech Republic).
    6 Hon Professor, Division of Surgery, C.H. Medical College, Kumaon University, India.
    7 Scientist, Spinal Cord Neurodegenerative Disorders & Stem Cell Research.
    8 Mother Cell & Revita Life Sciences.
    9 http://www.drhbf.org.

    • vincent.ard

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  • smut clyde
  • https://sites.google.com/site/lebedevneuro/home Mikhail Lebedev

    Wait till Gundyaev (the head of Russian church) publishes something.

  • Michael Lindsay

    Bloody hell. Invasive surgery and experiments on kids?

    That is insanely creepy.

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  • OWilson

    On another note, there’s always been a “grey” market for alternative medicine and surgery. Medicine has become so regulated in the West that governments must work slowly and carefully to license new drugs or endorse new treatments.

    But there’s a benefit and a curse in having the government totally liable for the kind of headache pills you are allowed to use, or even the size of a coke you can have in New York.

    Not so in the third world, where cheap knock off drugs can be picked up from store front so called “pharmacists” and everything from holistic surgery to voodoo love potions, can be had. Placedo effects are real, and someone who has been pronounced incurable, may well choose to spend their savings on these last resorts. The market exists.

    Even in the U.S. there are people gathering, cooking and ingesting “natural” substances which could potentially be lethal.

    “Ethical” is a moralistic and relative term and drinking the blood of dead virgins may be seen as acceptable, as long as the poor young lady met a legal end. Throughout history it has been considered ultimate recycling.

    There are two issues here. One is ethical and the other is effectiveness. Where the lines cross may depend of where you are, or how serious your malady. :)

  • smut clyde

    Yes, Americans have been subjecting their autistic children to stem cell injections into the spine for a decade, working through DAN doctors who somehow retain their medical registration, so it’s all legal:
    http://scienceblogs.com/insolence/2008/12/26/the-price-of-antivaccination-fanaticism/

    The well-known autism vulture Jeff Bradstreet was pimping some Ukrainian stem-cell-spinal-injection scammers before he moved onto different grifts —
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3677147/
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3999775/#B43
    — citing “clinical trials” in China and India.

    A 2013 Indian “Study” inflicted on 32 subjects ranging in age from 3 to 33:
    https://www.hindawi.com/journals/sci/2013/623875/

    Italy seems to be a haven for stem-cell autism injectors.

    Bansal hasn’t invented any new scam, he’s just trying to cash in on an existing con.

    • http://blogs.discovermagazine.com/neuroskeptic/ Neuroskeptic

      A history of shame.

  • UK Homeopathy Regs

    It’s worth pointing out that doctors can’t legally advertise in India – against Code of Ethics. There are also restrictions on what conditions can be mentioned in advertising.

    Bansal also offers vagina tightening with injections of adipose cells.

    • http://blogs.discovermagazine.com/neuroskeptic/ Neuroskeptic

      Hmm, good point. The “RegennMed” site looks full of advertising to me although it doesn’t mention specific services, doctors, or prices so maybe it’s technically not advertising?

      • smut clyde

        Bansal is also ReVita Life Sciences, which is *nothing but* advertising. Including (of course) stem cells for penis enlargement and ED. Also the whole scammocopoeia of coloured-light healing, hyperbaric oxygen, Naturopathy, Healing Electromagnetic Pulses, and griftolicious Ayurvedic Piffle.
        ReVita was to have been BioQuark’s partner in the regenerated-brains project (and its site is still promoting that scam). Well done BioQuark for due dligence with your partnerships! You really know how to pick them!

  • Stardust4U

    Interesting, thanks for the share.

  • Victor Rivera

    Wowza.

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Neuroskeptic is a British neuroscientist who takes a skeptical look at his own field, and beyond. His blog offers a look at the latest developments in neuroscience, psychiatry and psychology through a critical lens.

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