Thread: ChinaSCINet Update

  1. #2551
    Senior Member lynnifer's Avatar
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    Quote Originally Posted by Jim View Post
    The data suggests lithium & methylprednisolone are not effective, if confirmed in the next Phase II's, they will be dropped.
    Absolutely no one else was headed into that direction. How much money and time was invested in this?
    Make America Sane Again. lol

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  2. #2552
    Senior Member Moe's Avatar
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    Quote Originally Posted by Jim View Post
    Hey NM, I meant we will move forward if this therapy is confirmed to work, the clinical trial process is completed, and the therapy is approved by the FDA. Tweaking, def. The data suggests lithium & methylprednisolone are not effective, if confirmed in the next Phase II's, they will be dropped.

    We are working hard on Muse cells (pluripotent, umbilical cord blood cells.) It is possible they may be more effective than mononuclear cells. We are also trying them in the lumbosacral injury model.
    Is there a difference between Phase II and future IIs that makes it worth to re-trail lithium & methylprednisolone? If the 20(?) patients data suggests lithium & methylprednisolone are not effective off P-II in China, what makes this combination so special to suggest another try?
    Last edited by Moe; 02-18-2017 at 03:33 PM.
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  3. #2553
    Junior Member lampros's Avatar
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    I am worry. Is something change in Wise mind about the treatement method? or is for FDA approval?

  4. #2554
    Quote Originally Posted by lynnifer View Post
    Absolutely no one else was headed into that direction. How much money and time was invested in this?
    Many independent labs showed lithium is beneficial for recovery in rats, and methylprednisolone (MP) improves cell survival. Our lab tested, and found the same. That's why Wise and several other researchers decided to try it in the trial. It was not expensive or hard to do.

    Quote Originally Posted by Moe View Post
    Is there a difference between Phase II and future IIs that makes it worth to re-trail lithium & methylprednisolone? If the 20(?) patients data suggests lithium & methylprednisolone are not effective off P-II in China, what makes this combination so special to suggest another try?
    Download the PDF of the paper- http://www.ingentaconnect.com/search...ize=10&index=7
    Look at page 13. Group C received only the max injection of cells + intensive walking and had the best walking recovery. Group D received cells+lithium + MP, less return, Group E, cells + lithium, even less return. If the same results are repeated it will be enough evidence to drop lithium an MP.

    Quote Originally Posted by lampros View Post
    I am worry. Is something change in Wise mind about the treatment method? or is for FDA approval?
    No need to worry. We are on track to begin this Fall in the US.

  5. #2555
    Senior Member Wills77's Avatar
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    Will they allow people who already participated in another trial? Is there is certain time frame needed in between 2 separate trials?
    Thanks
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  6. #2556
    Quote Originally Posted by Wills77 View Post
    Will they allow people who already participated in another trial? Is there is certain time frame needed in between 2 separate trials?
    Thanks
    Generally, yes you will be able to participate, but will be decided case-by-case.
    You must be C5-T11, complete, no change in function for 6 months.

  7. #2557
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    Jim within how much time results expected from lumbosacral research whether muse cells going to work or not and how soon you will start human trials?

  8. #2558
    Forgive me if this was answered elsewhere, but are completes just the extreme starting point? Will this be trialed in incompletes and MS patients soon too?

  9. #2559
    Quote Originally Posted by Jim View Post
    Generally, yes you will be able to participate, but will be decided case-by-case.
    You must be C5-T11, complete, no change in function for 6 months.
    Hey jim, Key point here with the China clinical trial they incorporated the Kumming walking program six hours six days a week. Are they going to be continuing that protocol or something similar in America?

  10. #2560
    Quote Originally Posted by Sheri View Post
    Forgive me if this was answered elsewhere, but are completes just the extreme starting point? Will this be trialed in incompletes and MS patients soon too?
    The US IIb trial will be include only completes, India may include incompletes. We will know for sure in the coming months. This therapy will not be effective for MS.

    Quote Originally Posted by JamesMcM View Post
    Hey jim, Key point here with the China clinical trial they incorporated the Kunming walking program six hours six days a week. Are they going to be continuing that protocol or something similar in America?
    The plan is to do the same.

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