Thread: ChinaSCINet Update

  1. #2211
    Quote Originally Posted by Wise Young View Post
    Barrington314mx,

    Sorry to correct you. Please, don't call it involuntary walking. It is voluntary walking. The patients initiate, stop, and control the walking when they are standing and taking steps. They just can't move their legs very much when they are lying down prone, without sensory feedback.
    Ahh, thanks for the correction and answers.

  2. #2212
    Quote Originally Posted by kz View Post
    Dr. Young,
    Hi, I hope all is well . ONE QUESTION: All these improvements are fantastic (thank you for your hard work indeed) , and the first in the history of medicine (15 out of 20 chronic sci subjects are walking , and other improvements such as bladder and bowel function improvements ,etc.) as far as I know , SO , WHAT IS STOPING YOU FROM TAKING THESE GREAT RESULTS DIRECTLY TO FDA , and show them the results of the trial and see if you can get permission to start using it on people with sci RIGHT NOW (requesting compassionate use permission etc. ) while you are trying to perfect the result with phase 3 trial ,etc. ? You know that People are suffering and dying everyday from this devastating injury and the compassionate permission might saves a lot of people from so much suffering everyday and even dying (people are dying from sci complications all the time , I should know because I almost died from sci complication few times ) while we wait for phase 3 to start and finish and you know that might takes many years (that is not even started yet ) . Thanks for all you do , it is greatly appreciated .
    From a previous post-

    Quote Originally Posted by Wise Young View Post
    As soon as recruitment and treatment phase of the phase III trials are over in the United States and Europe, we will apply for compassionate use approval of the treatment, so that people don't have to wait for the completion of the phase III trials before having access to the therapy. I expect that there will be significant demand for the therapy if the trial turns out to be positive and therefore have been working with Stemcyte to establish an 3,000,000 (from 30,000 cord blood units) umbilical cord mononuclear cell library for this purpose by 2016.

    Our proposed clinical trial will randomize subjects to surgery without transplants or lithium, surgery with 6-week course of lithium, surgery with UCBMC transplants, and surgery with UCBMC transplants and 6-week course of lithium. All subjects will then receive a 3-6 month locomotor training.

    Wise.

  3. #2213
    Jim , I hope you are doing good . thanks for your post .
    I think based on current data (improvements) that Dr. Young reported from phase 2 trial results in china , FDA should be able to grant compassionate use of this therapy for those who are willing and need to use it until the therapy is more perfected and improved in phase 3 trial that will be done next year . based on my understanding and what dr. Young has said few times , there are not that much report of complications from cell transplant (umbilical cord cell etc. ) so far .
    There are many pills in the market that FDA has approved and is being used right now that has so many " side effects " (EFFECTS (I believe that there is not such a thing as SIDE EFFECTS , they are only EFFECTS ) and they are advertised on TV everyday .
    Some of the " side effects" (EFFECTS ) of these pills that are approved by FDA and is being used right now and they are on TV commercial every days are death , heart attack , heart failure , kidney failure , liver failure , suicide ,etc. etc. etc. , .
    One time I saw a commercial for a pill for treatment of depression (I forgot what was the name of the pill ) , and one of the " side effect " (EFFECT ) of it was suicide thought among other things ; I could never understood that one .
    Any way , My understanding is that so far (even though it is not that long ) there has not been any complications from the phase 2 China trial , and based on the good results from phase 2 China trial that Dr. Young has reported here and there , I think even though the phase 2 trial is not published yet , and based on all the things that Dr. Young has said about the results of this trial so far (15 out of 20 are walking to some extent , with improvement in bowel and bladder functions in some subjects , etc. ) , FDA should be able to consider the compassionate use of this therapy while the phase 3 trial will try to improve the results of this therapy .
    This is only a though , and I could be wrong , and I was wrong before .

  4. #2214
    kz, here is a decent read on compassionate use from the FDA website. http://www.fda.gov/ForPatients/Other...cm20041768.htm


    Quote Originally Posted by kz View Post
    Jim , I hope you are doing good . thanks for your post .
    I think based on current data (improvements) that Dr. Young reported from phase 2 trial results in china , FDA should be able to grant compassionate use of this therapy for those who are willing and need to use it until the therapy is more perfected and improved in phase 3 trial that will be done next year . based on my understanding and what dr. Young has said few times , there are not that much report of complications from cell transplant (umbilical cord cell etc. ) so far .
    There are many pills in the market that FDA has approved and is being used right now that has so many " side effects " (EFFECTS (I believe that there is not such a thing as SIDE EFFECTS , they are only EFFECTS ) and they are advertised on TV everyday .
    Some of the " side effects" (EFFECTS ) of these pills that are approved by FDA and is being used right now and they are on TV commercial every days are death , heart attack , heart failure , kidney failure , liver failure , suicide ,etc. etc. etc. , .
    One time I saw a commercial for a pill for treatment of depression (I forgot what was the name of the pill ) , and one of the " side effect " (EFFECT ) of it was suicide thought among other things ; I could never understood that one .
    Any way , My understanding is that so far (even though it is not that long ) there has not been any complications from the phase 2 China trial , and based on the good results from phase 2 China trial that Dr. Young has reported here and there , I think even though the phase 2 trial is not published yet , and based on all the things that Dr. Young has said about the results of this trial so far (15 out of 20 are walking to some extent , with improvement in bowel and bladder functions in some subjects , etc. ) , FDA should be able to consider the compassionate use of this therapy while the phase 3 trial will try to improve the results of this therapy .
    This is only a though , and I could be wrong , and I was wrong before .

  5. #2215
    c473s
    Thank you .

  6. #2216
    Great link c473s, thanks you

    For anyone that does know - am I right to assume this compassionate use is strictly for the United States (FDA)?

    How about Hong Kong? And also the EMA (European Medicines Agency, similar to the FDA in the US)? Will these allow compassionate use?

    As the Phase III trials also include Norway in Europe, will rhis apply to the EMA in Europe? Because as far as I know Norway is not part of the European Union (EU).

    Would it be possible for someone outside the US to travel to pay and take advantage of the compassionate use in the US?

    I just really hope that it isn't as ridiculously expensive as the fake stem cell tourism agencies in South America... boy do those guys rip you off... as far as I have researched it's usually one parent company that has lots of subsidiaries that market their dangerous and unapproved therapies towards not only people with SCI but literally everything such as Autism, Stroke, MS.

    They also charge you depending on where you're from, to milk you dry. Beware folks, I almost fell for it...

    Regards

  7. #2217
    ​That's a good point Taymas. I was wondering as well if that the compassionate use will be approved by the FDA in US, will it also be possible to have it in Europe? Or if it wouldn't, could anyone travel tu US and have the treatment there? Anyway, first of all I hope that it will be approved by the FDA and then maybe the EMA will consider to allow it in EU too...

  8. #2218
    Quote Originally Posted by Silvio GS View Post
    ​That's a good point Taymas. I was wondering as well if that the compassionate use will be approved by the FDA in US, will it also be possible to have it in Europe? Or if it wouldn't, could anyone travel tu US and have the treatment there? Anyway, first of all I hope that it will be approved by the FDA and then maybe the EMA will consider to allow it in EU too...
    Ahh a Dubliner! Well good new buddy!

    http://www.ema.europa.eu/ema/index.j...ent_000293.jsp

    It seems the EMA might be a little more forgiving than the FDA, especially the bit about "cohort of patients" as opposed to individuals. Hope you've checked out Damien Rice's new album

    This is promising. Hope this link is useful for someone if you're in Europe.

    Regards

  9. #2219
    Understanding EMA and ATMP

    There's been a lot of discussion on EMA ATMP Classifications so here is a good read on the whole EMA process.

    http://www.eucerd.eu/upload/file/Rep...tivitiesIV.pdf
    "I'm manic as hell-
    But I'm goin' strong-
    Left my meds on the sink again-
    My head will be racing by lunchtime"

    <----Scott Weiland---->

  10. #2220
    Quote Originally Posted by taymas View Post
    Ahh a Dubliner! Well good new buddy!

    http://www.ema.europa.eu/ema/index.j...ent_000293.jsp

    It seems the EMA might be a little more forgiving than the FDA, especially the bit about "cohort of patients" as opposed to individuals. Hope you've checked out Damien Rice's new album

    This is promising. Hope this link is useful for someone if you're in Europe.

    Regards
    Thanks Taymas, it does sound really promising and no I didn't check Damien Rice's album yet
    Regards.
    Last edited by Silvio GS; 11-19-2014 at 06:16 PM.

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