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Thread: Unproven stem cell treatment cause for alarm

  1. #1

    Unproven stem cell treatment cause for alarm

    From the San Diego Union-Tribune, 5/16/2013:

    High-quality scientific research is hard work. There are moments of serendipity, to be sure, but even the most inspired ideas demand scrupulous validation. Nowhere is that more true than in the health sciences and medicine where our well-being and lives are literally at stake.


    As stem cell scientists seeking new ways to treat many terrible diseases, we must take great care to ensure the therapies we develop are based upon sound scientific research, and proven to lack undesirable or life-threatening complications.


    Yet as we write, the Italian Parliament is considering legalization of an unproven, untested and largely unexplained stem cell treatment. Good science and lives are at risk, with potential implications and consequences for vulnerable patients and families in San Diego.
    Lawrence Goldstein, Ph.D., director, UC San Diego Stem Cell Program wrote this with fellow members of the scientific steering committee of the Sanford Consortium for Regenerative Medicine: Shu Chien, MD, Ph.D., director, UC San Diego Institute of Engineering in Medicine; Martin Friedlander, MD, Ph.D., The Scripps Research Institute; Fred H. Gage, Ph.D., professor, The Salk Institute for Biological Studies; Edward W. Holmes, MD, president, Sanford Consortium for Regenerative Medicine; Anjana Rao, Ph.D., professor, La Jolla Institute for Allergy and Immunology; Evan Snyder, MD, Ph.D., professor, Sanford-Burnham Medical Research Institute.
    For the rest of the commentary:

    http://www.utsandiego.com/news/2013/...ven-treatment/

    (KLD)

  2. #2
    Quote Originally Posted by SCI-Nurse View Post
    From the San Diego Union-Tribune, 5/16/2013:



    For the rest of the commentary:

    http://www.utsandiego.com/news/2013/...ven-treatment/

    (KLD)
    That's a load of BS, what will happen if it will be approved by the palament is that a number of teminally patients will receive this stem cell therapy as an act of compassion.
    It will all be done in GMP labs and patient's will be evaluated by indipendent teams of doctors. The trial should last 18 months and patients will not pay a cent.

    Problem is that if this will be approved there will be a fastest track to humans for stem cell therapies and the academic establishment will have less money to do more studies, to publish more BS papers that in most cases can't even be replicated.
    Researchers are getting ridicolus with this opposition, problem is that they are supported by big pharma, so they may even win this battle, but IMO probably not.

    Paolo

  3. #3
    Super Moderator Sue Pendleton's Avatar
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    What I don't get is why this effects anyone in San Diego. If they mean a family might take an ill member to Italy for medical tourism, well, that is their right. I remember my family discussing Mexico and laetrile with my younger brother's doctor. Once we understood how it worked in theory but not in reality that was crossed off the list leaving only palative care. Unless these doctors educate themselves so they can explain why something might or might not work on their terminally ill child maybe they should be honest and say 'I don't know but it's your money'. Nothing in the article said that Italy would allow foreign patients in what is a social medicine country for this trial/use.
    Courage doesn't always roar. Sometimes courage is the quiet voice at the end of the day saying, "I will try again tomorrow."

    Disclaimer: Answers, suggestions, and/or comments do not constitute medical advice expressed or implied and are based solely on my experiences as a SCI patient. Please consult your attending physician for medical advise and treatment. In the event of a medical emergency please call 911.

  4. #4
    Quote Originally Posted by Sue Pendleton View Post
    What I don't get is why this effects anyone in San Diego. If they mean a family might take an ill member to Italy for medical tourism, well, that is their right. I remember my family discussing Mexico and laetrile with my younger brother's doctor. Once we understood how it worked in theory but not in reality that was crossed off the list leaving only palative care. Unless these doctors educate themselves so they can explain why something might or might not work on their terminally ill child maybe they should be honest and say 'I don't know but it's your money'. Nothing in the article said that Italy would allow foreign patients in what is a social medicine country for this trial/use.
    The main concern of the academics I think is the "perceived danger" coming from having a country like Italy that is currently lined up with FDA standards that may have a much easier way to do clinical trials with stem cell therapies.

    Researchers from around the world have joined to try to stop that. They wrote letters to national newspapers, to the health authorities etc.
    I don't think people from other countries will be accepted in the trial, but I don't know for sure.
    The new regulation should be approved by the end of May, but several emendments can still be added, so "the establishment" can still win.

    Paolo

  5. #5
    The chamber of rapresentatives has approved the law that will allow the clinical trials using mesenchymal stem cell differentiated into neurons.
    It needs to be reapproved by the senate as few changes have been made, but it should be approved with no more changes.
    Founding of 3 millions euros have been made available to cover the cost of the trial that will be closely monitored by the italian medical authority.

    I don't know yet which deseases will be included, in general it will be for neurodegenerative deseases. SCI it's unlikely to be included (that I know) even if it has been mentioned in the past as a condition that may benefit from the therapy just within few months after SCI.
    The trial should start on July 1st 2013 and should last 18 months.
    To be noted that there are people already receiving this stem cell therapy, but I don't think they have been examinated by indipendent doctors to document chages properly.

    Paolo
    Last edited by paolocipolla; 05-21-2013 at 06:02 AM.

  6. #6
    Research is a business. Like politics, they campaign for money hence a job. They spend that money as they please. Are the audited? I don't know but it is a job. If a cure was found then what?.....................There is no money in the cure.......
    Han: "We are all ready to win, just as we are born knowing only life. It is defeat that you must learn to prepare for"

  7. #7
    Senior Member lunasicc42's Avatar
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    I wish people would look at is as there is huge savings in a cure and just general need. I mean a cure would ease a whole gammit of burdens on society... Socially and economically
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  8. #8
    The senate has also approved the law that will allow this clinical trial to happen.

    I think likely the trial will show the therapy does not work for any desease, but I hope to be wrong.

    What should be good of all this story is that in the future, when there will be a stem cell therapy ready to go to trial, there should be less regulatory obstacles.

    Paolo
    In God we trust; all others bring data. - Edwards Deming

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