Thread: ChinaSCINet Update

  1. #2391
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    Patients from other countries can enroll?

    Hi,

    I saw that you had trouble in finding patients AIS A chronic. My brother is AIS A chronic but we live in Romania.
    Can he participate in your trials? Are there foreign patients accepted?

    Thanks,
    Robert.

    [QUOTE=Wise Young;1786561]DaDutchman,

    We did have some trouble finding patients that were AIS A chronic in Hong Kong for our phase I trial. However, in China, this was not as much of a problem. So, in the upcoming Phase II trial that will be submitted to the U.S. Food and Drug Administration (FDA) and to the Drug Controller General of India (DCGI), we have decided to include patients who were initially AIS A and then converted to B or C. We call these severe stable spinal cord injury rather than complete spinal cord injury who are not walking. Note that most patients that are initially AIS B or C generally recover walking within a year.

  2. #2392
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    Wise,
    What are the centers in the U.S. that will be carrying out your trial?

  3. #2393
    Hi Dr. Young and Jim,
    Checking in and can't help but be disappointed that 2015 is drawing to a close and your paper is still not published. Clinical trials not started in the US or internationally. Can you give us an update? When can we expect to review your results in an internationally recognized scientific publication? When can we expect clinical trials in the US to begin? I understand that trials depend upon financing, but I cannot understand the continued delay in publication.

    Really hoping that 2016 will bring significant advancements in the recovery of chronic spinal cord injured.

    beachlover

  4. #2394
    Quote Originally Posted by Wise Young View Post
    tompocket, the paper has been submitted and is under review right now. We had submitted it to 4 other journals that returned it without review. If it is accepted, the paper should be published in March or April of 2016. Wise.
    Wise, I think I speak for everyone here when I say I appreciate your honesty about your paper's submission history. Cheers.

    To follow up, can you tell us which journals returned your paper? Did any of the returned papers come with any explanation of the return?

    Finally, are you at all concerned that four journals rejected what appears (from 10,000 feet away) like a groundbreaking project on a poorly researched topic?

    I look forward to your response.

    Much thanks,

    Kyle

  5. #2395
    Quote Originally Posted by cripwalk View Post
    Wise, I think I speak for everyone here when I say I appreciate your honesty about your paper's submission history. Cheers.

    To follow up, can you tell us which journals returned your paper? Did any of the returned papers come with any explanation of the return?

    Finally, are you at all concerned that four journals rejected what appears (from 10,000 feet away) like a groundbreaking project on a poorly researched topic?

    I look forward to your response.

    Much thanks,

    Kyle
    This.

    If I remember correctly, they returned it because it was too "specialised." But really, FOUR rejections?

  6. #2396
    Quote Originally Posted by Wise Young View Post
    DaDutchman,

    We did have some trouble finding patients that were AIS A chronic in Hong Kong for our phase I trial. However, in China, this was not as much of a problem. So, in the upcoming Phase II trial that will be submitted to the U.S. Food and Drug Administration (FDA) and to the Drug Controller General of India (DCGI), we have decided to include patients who were initially AIS A and then converted to B or C. We call these severe stable spinal cord injury rather than complete spinal cord injury who are not walking. Note that most patients that are initially AIS B or C generally recover walking within a year. As soon as the FDA and the DCGI approve the protocol, we will of course announce the trial on www.clinicaltrials.gov and on this site, along with all the contact information. The participating centers will be the ones that choose people for the trial. Each of 3 centers in each country will choose 6 participants in the trial.
    Wise,

    Thank you for your response. I apologize for not checking earlier to see if there was a response.

    At this point, my course of action would be to register at the site www.clinicaltrials.gov. If this is incorrect, please let me know. Also, and I believe someone has asked this same question, what are the 3 centers for the US?

    Once again thank you very much for your time and efforts. May the year 2016 bring about many fruitful and meaningful results.

    Sincerely
    DaDutchman
    C5/C6 since 2007 due to car accident

  7. #2397
    DaD, when there is news about the upcoming clinical trials we will send out a blast email. If you want to receive, email me at jimbenn@rutgers.edu.

  8. #2398
    Thanks for the feedback Jim. Please look for an e-mail from me.

    DaDutchman
    DaDutchman
    C5/C6 since 2007 due to car accident

  9. #2399
    Senior Member Moe's Avatar
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    I'm curious about the original P-I & II patients who participated several years ago that had gained some recovery doing 666's n'all... any updates/anything else new in regards of their progress/recovery that can be shared here?

  10. #2400
    Last I heard, they are planning to bring the patients back to examine.

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