Thread: ChinaSCINet Update

  1. #2041
    Woo hoo!! Onward and FORWARD!! Come on FDA, time to MAN up!!

  2. #2042
    Senior Member
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    There going to have to piece us back together like humpty dumpty. Hopefully this is the first piece.

  3. #2043
    Quote Originally Posted by Jim View Post
    Eric,

    I work with Dr. Young at Rutgers.

    The ChinaSCINet Phase II Trial has been completed. 15 of 20 subjects are able to walk long distances using upper body supporting rolling walkers. 2 of the 15 are able to walk with walkers. Most subjects had major increases in their Spinal Cord Independence Measure scores, mainly in the mobility/bowel/bladder categories.

    Phase III Trials are now being planned to take place next year in China, US, Norway and India.

    Attachment 55475

    Thanks a lot for the clarification Jim, much appreciated. Are you able to comment on the progress of publication? I guess it's too early to predict whether the third phase will be first or second half of 2015?

    Jim would you consider a new sticky thread on the forums for Phase III when it commences? Something like a Q&A, with updates etc. But then again there probably isn't much more to say that hasn't been said over here, and could be unnecessary hype :P

    Kindest Regards

  4. #2044
    Quote Originally Posted by Jim View Post
    Eric,

    I work with Dr. Young at Rutgers.

    The ChinaSCINet Phase II Trial has been completed. 15 of 20 subjects are able to walk long distances using upper body supporting rolling walkers. 2 of the 15 are able to walk with walkers. Most subjects had major increases in their Spinal Cord Independence Measure scores, mainly in the mobility/bowel/bladder categories.

    Phase III Trials are now being planned to take place next year in China, US, Norway and India.

    Attachment 55475
    hmm, sounds like this procedure really works. I've argued against the time consuming and overly expensive way clinical trials are held but its good to see that this one is actually producing good results. hopefully these results will pan out for all of us...

  5. #2045
    Quote Originally Posted by Eric.S View Post
    hmm, sounds like this procedure really works. I've argued against the time consuming and overly expensive way clinical trials are held but its good to see that this one is actually producing good results. hopefully these results will pan out for all of us...
    Yeah absolutely, hope you've got the some answers, though there are many more on our minds. It seems like a massive hurdle to overcome, and I can't think of any therapy that has made it this far, in terms of trying to gain official approval. The results are promising, and it's a very strong foundation towards recovery. There still is a while before we see this therapy being adopted by healthcare bodies around the world. I can only speculate the resources required, such as dedicated labs, training for healthcare professionals - ESPECIALLY physiotherapists, due to the nature of intensive locomotor training. Here in the UK, I was at the NSIC (National Spinal Injuries Centre), at Stoke Mandeville Hospital, Aylesbury, which was regarded the "holy grail" of SCI research and rehab - I strongly and bitterly disagree, there is absolutely NO scope of recovery there, with a typical wait and see attitude, and minimal surgeries of fear of liability.

    Whilst I was thankful to see a dedicated physiotherapy gym, there were only a handful of standing frames, a couple PASSIVE leg bikes, ONE weight supported treadmill and one FES bike. The lone bike and treadmill were in heavy demand, and most of us were denied use of them as "they won't work on you." Which is understandable.

    But my question is to those that can answer, what does the locomotor training involve? Maybe a rough workout schedule? How on earth, and importantly how long before we see patients start receiving treatment? I know some mentioned "compassionate use" early treatment, but what countries would that apply to?

    I know I ask too many questions, but it seems my life has come down to sadly sitting behind a computer screen, as a keyboard warrior. This, of course, won't apply to all SCI people, there are many of you who are active and well, and make the most of life. But there are some who are in dire straights with daily living, and some even worse off - whether it be physically, mentally or FINANCIALLY.

    I want to work, get a job rather than rely on the state, and worry about being thrown in to a care home or old folks home. As it stands I had been THROWN in to a hostel expected to live off ?56 a week. I could try get a job, and all of this would be bearably, but oh God the PAIN is unbearable, the burning, stinging, feeling like my ankles are snapped clean off, stinging in my groin, the autonomic dysreflexia, and this bloody syringomyelia that's affecting my upper body. I'm sure most would say shut the hell up, man up, and get on with it. I do, - I just have this moment every now and then x

    Oops went off topic a bit. As you can see guys there are so many questions - would any moderators consider a sticky thread on the forums that have typical questions regarding phase three, that are answered in the original post? It's been done before but we need something specific to phase three, only if you have the time. I would like to offer some help, and I have plenty experience in moderating forums, and especially public relations (what can and can't be shared)

    Warmest regards possible, from this strained, torn, shreaded heart.

  6. #2046
    Wise presented preliminary results almost two years ago, my understanding is that it does not work. See this video: https://www.youtube.com/watch?v=8VsK8lz6vZ8
    Pay attention at minute 37:50

    I hope at W2W more details will be presented.

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

  7. #2047
    Quote Originally Posted by Wise Young View Post
    Dan,

    Patients are not permitted to pay for experimental therapies that have not yet been approved by the relevant governmental agencies, e.g. the FDA in the U.S. and the EMA in Europe. So, one cannot pay for participation in a clinical trial. The clinical trials are essential for obtaining evidence of safety and efficacy so that the treatment can be approved by the regulatory agencies, so that doctors can apply and insurance can pay for the therapy. On the other hand, it is possible to companies to apply for "expanded use access" to the therapy, as long as the expanded use does not interfere with the phase III trials needed to demonstrate the safety and efficacy of the therapy. Originally called "compassionate use" therapy, the expanded use access program allows companies to apply to allow patients to pay cost of the treatment that has been shown to be safe and has some promise but have not yet been approved. The treatment must be applied by qualified doctors, there should be no alternate therapy, and the condition must be serious (i.e. life-threatening or severely disabling). I have proposed to Stemcyte (the company providing the umbilical cord blood mononuclear cells) that they apply for expanded use access after the phase III trial starts in 2015. I am working closely with the company to help them expand the production of the cells so that it can treat thousands of people. So far, the company has provided several hundred units of umbilical cord blood for the clinical trials.

    Wise.
    Wise,

    does that mean that people with SCI may get access to therapies Originally called "compassionate use" therapy?

    I was just reading this article about the right to try (I see it has been introduced in New Jersey too):

    http://www.hoover.org/research/end-fda-paternalism

    "The Goldwater Institute this year brought the idea to three states - Colorado, Missouri, and Louisiana - and it was approved by the legislatures in all three unanimously. Meanwhile, the Arizona Legislature voted to refer Right to Try to the November 2014 ballot, and Right to Try measures also have been introduced in Delaware, Michigan, and New Jersey."



    Do you think SCI could fall into "The Right to Try" concept cosidering also life expectancy for people with high cevical injuries is significantly reduced?
    ( https://www.nscisc.uab.edu/PublicDoc...cts%202013.pdf )

    Paolo
    Last edited by paolocipolla; 08-18-2014 at 04:40 AM.
    In God we trust; all others bring data. - Edwards Deming

  8. #2048
    Quote Originally Posted by Jim View Post
    Eric,

    I work with Dr. Young at Rutgers.

    The ChinaSCINet Phase II Trial has been completed. 15 of 20 subjects are able to walk long distances using upper body supporting rolling walkers. 2 of the 15 are able to walk with walkers. Most subjects had major increases in their Spinal Cord Independence Measure scores, mainly in the mobility/bowel/bladder categories.

    Phase III Trials are now being planned to take place next year in China, US, Norway and India.

    Attachment 55475
    Norway? No-way, from what I know.

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

  9. #2049
    Quote Originally Posted by Jim View Post
    Eric,

    I work with Dr. Young at Rutgers.

    The ChinaSCINet Phase II Trial has been completed. 15 of 20 subjects are able to walk long distances using upper body supporting rolling walkers. 2 of the 15 are able to walk with walkers. Most subjects had major increases in their Spinal Cord Independence Measure scores, mainly in the mobility/bowel/bladder categories.

    Phase III Trials are now being planned to take place next year in China, US, Norway and India.

    Attachment 55475

    Hello Jim, thank you for share this info, I have a question for you? how many of them were treated with placebos?

    regards

    Jose

  10. #2050
    Quote Originally Posted by paolocipolla View Post
    Wise presented preliminary results almost two years ago, my understanding is that it does not work. See this video: https://www.youtube.com/watch?v=8VsK8lz6vZ8
    Pay attention at minute 37:50

    I hope at W2W more details will be presented.

    Paolo
    HOLD ON. So it is INVOLUNTARY walking? Is this correct? How can COMPLETES walk if they haven't had any motor changes? So they walk involuntarily, right? Someone clear my confusion, my head hurts from trying to figure it out.

    In the video Dr Wise says the patients didn't have any motor changes, but some ended up walking. So this means it does work Paolo? Forgive me, I don't have a huge understanding of the science behind all this Paolo, if it's not too much hassle could you please briefly clear this up for me? Because all this now seems very misleading

    Regards
    Last edited by taymas; 08-18-2014 at 10:23 AM.

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