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!

        • Stop2015

          Indian citizen here… Will get back with details of the fellow and possible legal implications. All human research is bound to be in accordance with ICMR (Indian council of Medical Research) guidelines which are pretty much in line with Helsinki and ICH statutes.
          In India, Stem cell is the new age homeopathy. But, it was limited to cheap cons like preservation of cord cells etc. Pulling off an invasive human experimentation, while not impossible, would have required high amount of craftiness.

    • 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.

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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. :)

    • Girish

      What is wrong If stem cell application is done as study and published . Criticism is good but labelling it conmanship is too dirty
      All across world stem cell being explored for various neurological issues and we have tried to evaluate what has been done before.
      Regarding brain death reversal the study is ongoing and we believe it’s high time to challenge 50 yr old definition of brain death

  • 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.

    • Martin

      Hello everyone, there are so many groups working with stem cells and not even publishing their results, there are few groups who are working with proper ethical committee approvals and registered clinical trials, Smut have cited some of them.
      My concern is why only one study is being questioned and its not the matter of study, by seeing the entire discussion one can make out that target is the Doctor who did this study. If somebody is publishing some results just for awareness, what’s wrong? what is there for those who are commercially exploiting stem cells and not even publishing to escape from all the criticism.He is not the only one published stem cells study, there are so many clinical trials registered and articles on net ,than why all discussion is about one study and one person? It appears to be biased, if genuinely we are concerned we should discuss about all groups and trials

    • Martin
  • 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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  • monica

    seems like india is not the only place ripe with stem cell scammers.
    https://justicefordrmajid.wordpress.com/
    What is the point of having a code of ethics if you totally ignore the ethics part?

  • Liberate Science

    Volume 9 Issue 4 (Journal of Stem Cells)
    Second paper:

    Clinical Safety in Using Unmatched Allogeneic Umbilical Cord Blood
    Mononuclear Cells Transplantations in Non-Haematopoietic Degenerative
    Conditions
    Rajni Vyas, Daya Dudhat, Pramodkumar Navik, Niyati Sudhalkar,
    Vaishali Garg, Jaymesh Thadani, Anant Marathe, Ramesh Bhonde, Bhaskar Vyas, and Kaushik Deb

    Last author: Kaushik Deb

    Same Kaushik B. Deb behind Retraction Watch DMCA takedown?

    http://retractionwatch.com/2016/12/16/weve-temporarily-removed-retraction-watch-post-heres-hint-bad-law/

    If yes, then note:

    https://www.readbyqxmd.com/read/27125141/human-umbilical-cord-mesenchymal-stem-cells-in-the-treatment-of-duchenne-muscular-dystrophy-safety-and-feasibility-study-in-india

    http://file.scirp.org/pdf/AAR_2015052916240635.pdf

    https://www.researchgate.net/researcher/2075539830_Kaushik_Deb

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

      Great point! I will look into this. It’s quite a coincidence if there are two stem cell researchers called Kaushik Deb

  • Liberate Science

    Same Kaushik Deb?

    Article 5 – Chondroprotection Using Naturally Occuring Mineral Supplementation Formula in Degenerative Osteoarthritis of the Knees
    Authors / Editors: Himanshu Bansal, Anupama Bansal, Diwaker Agrawal,
    Dhananjay Singh, and Kaushik Deb

    https://www.novapublishers.com/catalog/product_info.php?products_id=48499

    http://retractionwatch.com/2014/12/09/faking-data-earns-stem-cell-researcher-ban-federal-funding/

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  • Girish

    I don’t understand the comments as fraud or conmanship for a study
    Criticism is valid . Trying to establish a concept in proof of concept study is the very basis of research .
    One may have reservations on study design , results discussion etc . That is why these are published . A scientific criticism is valid and beyond this is biased .

    What is wrong in An attempt to verify 50 years old definition of brain death .
    To make clear the study is ongoing and early results are encouraging

  • Cayley

    This is just ridiculous, honestly. There should have been proper steps taken to get ethical approval, not that there would have been any approval at all in this study. First of all, it is an invasive procedure with no extensive explanation on why the researcher believed this invasive procedure would be useful or beneficial to anyone. Another reason would be that this procedure was performed on children, that is a whole other argument in itself. The article states that other actions were taken such as different forms of therapy and intervention which could be the cause of the positive outlook on the study, not the invasive procedure.

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

      Agreed!

  • awiggy

    Research of this nature is constantly under scrutiny. The set up of this research project failed the participants. Invasive procedures are monitored very closely by review boards in America, and from the sound of it, this project was not properly reviewed or overseen by an ethics board.

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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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