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Isn't this Wise Young Scinetusa? Says it's recruiting?

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  • Jim
    replied
    Doesn't make sense to me either. We are no longer affiliated with StemCyte.

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  • Moe
    replied
    But then again, why repeat phase II? After all the trouble and waiting to have it published in reputable medical journals from the China one... Why do it again? makes no sense to me, seems to be a waste of time and funds, why not move forward to phase III in Taiwan instead of II? wasn't this supposed to be a network?

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  • Jim
    replied
    The plan still is to conduct the phase III in US, China, and around the world. Couldn't tell you why StemCyte does what they do.

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  • Moe
    replied
    But why repeat the same exact China's Phase-II trial in Taiwan, what good is that going to do? if it would picked up and continued were ChinaNET left off, going forward to P-III would made alot more sense and exciting... Nothing seems to move forward anymore, just talk, repeating the same thing over and over since 2013. Feels like Stemcyte doesn't believe in investing in this technology anymore neither, they see no potential in this? China would have moved forward a long time ago to P3 no matter the obstacles if this really had that much potential. Yes I'm very excited about Taiwan. (sarcasm)
    Last edited by Moe; 13 May 2022, 1:20 PM.

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  • Jim
    replied
    StemCyte pulled out of the trial so we needed to find a new source of umbilical cord blood stem cells. Now working with New York Blood Bank, and two other banks. Had to go through the IND approval process from the beginning. The FDA is requiring an additional study to prove the new sources of cells are also safe and effective. Hope to start the trial later this year.

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  • Moe
    replied
    Quote from site:

    "This study is a randomized controlled, Phase II, two-arm study of Umbilical Cord Blood Mononuclear Cell (MC001) transplant into the injured spinal cord followed by the locomotor training for up to 5±1 hours a day, 5±1 days a week, for 3-6 months.

    A total of 18 subjects with chronic complete spinal cord injury (SCI) will be randomized to one of the two groups. The subjects assigned to Group A will receive 6.4 million UCBMNC (MC001) transplanted into the dorsal root entry zones above and below the injury site exposed by a laminectomy. Subjects in Group B will not have MC001 transplant or surgery. All subjects will receive 3-6 months of intensive locomotor training."

    Great they're recruiting in Taiwan. Now my question is: Why repeat the same trial that was done in China 10 years ago?? I could of understand the Phase IIb in the USA due to FDA n all, but what's so good and different about this trial in Taiwan. In what way this will benefit us? Whats preventing doing phase III in china instead?? No, we'll do phase II again this time in Taiwan that may end up nowhere like the one in China... What's going on for the US IIb? is it all talk or really going to happen?
    Last edited by Moe; 12 May 2022, 10:14 PM.

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  • Mitchitsu
    replied
    Looks like it. Unfortunately it also looks like they are only recruiting in Taiwan right now

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  • Jim
    replied
    The company, StemCyte pulled out of the US trial. They are doing a smaller trial in Taiwan.

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  • Isn't this Wise Young Scinetusa? Says it's recruiting?

    https://clinicaltrials.gov/ct2/show/...draw=5&rank=31
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