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Thread: ChinaSCINet Update

  1. #2721
    Quote Originally Posted by Moe View Post
    My hopes in these trials are pretty much faded out by now. All predicted dates seem to never work out for years and the so-called 'significant recovery' in participant from passed phase II in China are not even followed-up with a reason that the participated live "too far" (within China btw) to collect data, but yet think to be able to manage further countries like US, India, Norway... Really I don't get it.

    Now seems nothing predicted is not going to happen again this year except maybe in the US when the FDA application goes through which I can't understand again how can trail dates be predicted in the US if the application hasn't even been submitted yet.

    Happy 7th anniversary ChinaSCINet Update thread.

    I'm pretty much done here - Thanks for all the hard work and effort the same.
    Maurice, when Wise met with the US FDA they required an additional long term safety experiment to be done at our lab, and repeated at another facility. This added over a year and a million dollars. The data has been collected and is being written up by Wise. Big pharma companies have teams to do this, Wise does this on his own and saves tens of thousands of dollars. He is on 'vacation' and probably working on it at least 8 hrs a day. Once the IND is submitted, they have 90 days to get back to us. Last month, the US Clinical Trial Core Committee met to work out the details of the trial. There are a lot of things going on behind the scenes.

    I understand your frustration and wish you had my perspective, you would understand how difficult this is to pull off, just in the US. Wise is doing this in 3 countries simultaneously, and has to visit monthly to make sure things are getting done.

    Quote Originally Posted by nrf View Post
    I don't believe any Peer Reviews have even looked at the "trials" for ChinaSCINet? Is it dead in the water?
    The FDA is judge and jury.

    Quote Originally Posted by lunasicc42 View Post
    Same here ...I think I am going to do it once available but on the other hand, I haven't seen any strong concrete evidence that it's only mildly beneficial and I am a quad so I am more concerned with return of upper extremity function, I am hoping for better results when this next paper is published and sometimes people involved in the trial will kind of hint that the trial worked but haven't straight-up said it yet and I can't figure out if the quietness is due to the trial not being that robust or because they can't share the more robust data yet
    Luna, going from complete to incomplete is a huge deal some, A-C. Many gained independence in bowel and bladder care, and 75% walked with major to little assistance. In the upcoming trials we will also focus on the hands, arms, and sexual function. One of the subjects in China reported impregnating his wife the old fashion way.

    Quote Originally Posted by Silvio GS View Post
    My hopes on these trials faded away too a long time ago, too many things that didn't add up and put me off trusting it.
    I'm also wondering what's the real reason we haven't heard anything here from Wise in quite some time.
    Wise simply doesn't have the time and energy to be on CC.

    Bottom line, The ChinaSCINet Phase II Trial was a safety study in 23 subjects. The results were much more robust than expected. We hope to repeat these results and go beyond, have this standardized as a treatment, and move on to the next most promising therapy. And yes Jawaid, hopefully our lumbosacral research will be far enough along to start trials!
    Last edited by Jim; 08-11-2017 at 10:13 PM.

  2. #2722
    Senior Member lunasicc42's Avatar
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    Hey Jim, hope your holding up well
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


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  3. #2723
    Senior Member lunasicc42's Avatar
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    it may just be my layman pea brain but saying that the "patients went from complete to incomplete" was always just too much of a vague answer for me. I was always looking to hear what specific physical and autonomic functions can the participants do for themselves that they couldn't do before treatment. And I need more info on the bladder situation ...is it like back to normal where you can just internally and automatically Release your bladder and pee or is it that situation described before where one scratches or taps on a certain place on the Thigh causing the bladder to Release? I am a quad with little arm and no hand function so I couldn't scratch or tap any spot anyhow...if needed ...and about arm function, even if bladder function is restored to normal I don't have the arm or hand function to grab and point my dong to the proper receptacle. Other physical logistic questions remain but I will leave just these for now.
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


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  4. #2724
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    Red face

    Thanks Jim for keeping us in line!!

  5. #2725
    Where will this trial be held once it opens up? I'm in north Florida but I have no problem traveling to be a part of this...

  6. #2726
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    Jim, just a thought, but there are likely scientists and technical/proposal writers within the SCI community who would volunteer their time to help Wise speed things up...
    T3-T7 complete since Sept 2015

  7. #2727
    Quote Originally Posted by lunasicc42 View Post
    it may just be my layman pea brain but saying that the "patients went from complete to incomplete" was always just too much of a vague answer for me. I was always looking to hear what specific physical and autonomic functions can the participants do for themselves that they couldn't do before treatment. And I need more info on the bladder situation ...is it like back to normal where you can just internally and automatically Release your bladder and pee or is it that situation described before where one scratches or taps on a certain place on the Thigh causing the bladder to Release? I am a quad with little arm and no hand function so I couldn't scratch or tap any spot anyhow...if needed ...and about arm function, even if bladder function is restored to normal I don't have the arm or hand function to grab and point my dong to the proper receptacle. Other physical logistic questions remain but I will leave just these for now.
    The graph on the 6th page of the paper lists every subject, their level, time injured, and any changes that occurred.
    http://www.ingentaconnect.com/search...ize=10&index=7

    Quote Originally Posted by Natto View Post
    Where will this trial be held once it opens up? I'm in north Florida but I have no problem traveling to be a part of this...
    New York/New Jersey

  8. #2728
    Senior Member lunasicc42's Avatar
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    it's said that wise is currently writing for the next phase paper to be published ...I am not attempting to make light of what has been achieved but are you allowed to just say if the results of this phase were more robust or not, without giving any details? Would that be Acceptable?
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


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  9. #2729
    Senior Member lunasicc42's Avatar
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    Quote Originally Posted by lunasicc42 View Post
    it's said that wise is currently writing for the next phase paper to be published ...I am not attempting to make light of what has been achieved but are you allowed to just say if the results of this phase were more robust or not, without giving any details? Would that be Acceptable?
    sorry if that is too much prying and prodding. Just dying to live
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


    2010 SCINet Clinical Trial Support Squad Member
    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

  10. #2730
    No need to apologize.

    When Wise met with the FDA for a pre-IND meeting in '16, they requested an additional animal safety study to be done at our lab, and repeated at another facility (80 rats each). Wise is writing up the results of these experiments which will be submitted with the IND application for final approval to begin the trial. No safety issues were found. It may have already been submitted, Wise as been away for a weeks. The FDA then has 90 days to answer.

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