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Thread: How much longer?

  1. #121
    Quote Originally Posted by Schmeky View Post
    Help me out here Leo. I don't log on to CC very often, but I am aware of the NASCINET. Tell me how you are able to get into phase II, I thought a phase I had to be completed first.

    I really don't know this.
    Schmeky,

    The phase 1/2 lithium and cell transplants trials are being done in Hong Kong, Taiwan, and China. After the phase 2 trials are completed, in 2010, we are planning to do parallel phase 3 trials in China and the USA. The phase 2 trials will compare three treatment groups: a 6-week course of oral lithium only, umbilical cord blood mononuclear cells transplanted above and below the injury site with a bolus dose of methylprednisolone, and the cell transplant plus 6-week course of oral lithium. Because the costs of the trials are lower in China, we will be assessing 400 subjects there, both complete and incomplete. In the USA, we are planning on approximately 180 subjects emphasizing completes only.

    In addition to the phase 3 trials, we are planning a series of smaller phase 2 trials to establish the safety and feasibility of treating subjects who are younger than 18 and older than 64. We are also thinking about designing specific trials for people who have injury levels that are higher than C5 and lower than T10, as well as people with transverse myelitis from inflammatory or ischemic causes. The latter groups are likely to require different treatment protocols and outcome measures.

    In China, we are also currently planning trials of a new surgical approach to intradural decompression of subacute spinal cord injury. If successful, this approach will provide an approach to transplanting cells into the spinal cord in subacute spinal cord injury. This will be the first surgically controlled subacute (1-8 weeks) cell transplant study. This is something that we are currently applying for permission to do. If this is successful, there is strong interest amongst several U.S. centers to start doing this in the U.S.

    Wise.

  2. #122
    Senior Member Schmeky's Avatar
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    Dr. Young,

    So if I understand this correctly, the phase I & II done overseas will be acceptable in the USA? This is how Leo can go into a phase II here in US in 2010, correct?

  3. #123
    Senior Member Leo's Avatar
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    Quote Originally Posted by Schmeky View Post
    Help me out here Leo. I don't log on to CC very often, but I am aware of the NASCINET. Tell me how you are able to get into phase II, I thought a phase I had to be completed first.

    I really don't know this.
    Schmeky, If we work our ass off we'll be having that phase 1 next year, i'm moving forward with the thinking it will work, so phase 2 follows and i get in 2011.

    i don't meet the requirments for phase 1 but figure that will change for phase 2

    I don't have inside info, however by posting such as i did i am trying to influence the people that make those decisions ie Dr. Young.....whom ever

    Schmeky, you fit the criteria for the coming trial.

    Are you not going try to be one of the 100 or more who will get in?

    Freebird, i'm 33 yr post and 50+ and also lived a pretty full life

    but to miss the opportunity to experience the rush and the high that some recovery would bring i'll not leave that to the acutes

    i want to experience driving again and pinching the ass of a hot chick....yada yada
    http://justadollarplease.org/

    2010 SCINet Clinical Trial Support Squad Member

    "You kids and your cures, why back when I was injured they gave us a wheelchair and that's the way it was and we liked it!" Grumpy Old Man

    .."i used to be able to goof around so much because i knew Superman had my back. now all i've got is his example -- and that's gonna have to be enough."

  4. #124
    Senior Member Schmeky's Avatar
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    Quote Originally Posted by Leo
    Schmeky, you fit the criteria for the coming trial. Are you not going try to be one of the 100 or more who will get in?
    No. I'm working full time now. I'm of the opinion this is a trial for the sake of trials, not necessarily for remarkable recovery. This is absolutely no reflection on the herculian efforts of Dr. Young.

    I don't think the recovery we want/need is available at this time.

  5. #125
    Senior Member Duran's Avatar
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    Quote Originally Posted by Leo View Post
    Schmeky, If we work our ass off we'll be having that phase 1 next year, i'm moving forward with the thinking it will work, so phase 2 follows and i get in 2011.
    Leo, the rats are beginning to be envious of you! Don't try to be in competition with them.

  6. #126

    far-fig-nuggen!

    Agreed!!! A Votre Sante

    Quote Originally Posted by Timaru View Post
    Or, of course, the world as we know it may come to an end before a cure is found.

    Do all you can to assist in the hunt but learn to live a full life as you are.

  7. #127
    My mind needs FAR more recovery than my body does.

  8. #128
    Quote Originally Posted by Schmeky View Post
    ..... I'm of the opinion this is a trial for the sake of trials, not necessarily for remarkable recovery.......
    I understand your point of view and I think many here think like you, but
    I disagree.
    We have been reading for so long about research that works on rats. We now have something to start from on chronic humans... do you wanna wait other 5-10 years? In the case it doesn't improve significant function in patients at least we'll have learned many things on doing cell transplant in SCI etc.
    Very important, in my opinion, is also the fact that with the SCINetUSA we'll test the "machine" for doing clical trials for chronics so that the next therapy will not remain sit in labs for years before being tested on humans.
    So if you are not interested in partecipating in this trial you must be happy enough with your current life and, if that is the case, I am sincerily happy for you.

    Paolo
    Last edited by paolocipolla; 07-07-2009 at 12:01 PM.

  9. #129
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    I don't think anybody will ever be able to give you an exact timeline on how long. I think we'll come in here hoping to see in big letters cure 4sci... just keep on holding on keep on dreaming and believing it will happen in your lifetime, it makes every day nobody easier, almost 13 years C3 quad complete,

  10. #130

    Question Also how long?

    Quote Originally Posted by Wise Young View Post
    Schmeky,
    Quote Originally Posted by Wise Young View Post

    The phase 1/2 lithium and cell transplants trials are being done in Hong Kong, Taiwan, and China. After the phase 2 trials are completed, in 2010, we are planning to do parallel phase 3 trials in China and the USA. The phase 2 trials will compare three treatment groups: a 6-week course of oral lithium only, umbilical cord blood mononuclear cells transplanted above and below the injury site with a bolus dose of methylprednisolone, and the cell transplant plus 6-week course of oral lithium. Because the costs of the trials are lower in China, we will be assessing 400 subjects there, both complete and incomplete. In the USA, we are planning on approximately 180 subjects emphasizing completes only.

    In addition to the phase 3 trials, we are planning a series of smaller phase 2 trials to establish the safety and feasibility of treating subjects who are younger than 18 and older than 64. We are also thinking about designing specific trials for people who have injury levels that are higher than C5 and lower than T10, as well as people with transverse myelitis from inflammatory or ischemic causes. The latter groups are likely to require different treatment protocols and outcome measures.

    In China, we are also currently planning trials of a new surgical approach to intradural decompression of subacute spinal cord injury. If successful, this approach will provide an approach to transplanting cells into the spinal cord in subacute spinal cord injury. This will be the first surgically controlled subacute (1-8 weeks) cell transplant study. This is something that we are currently applying for permission to do. If this is successful, there is strong interest amongst several U.S. centers to start doing this in the U.S.

    Wise.
    Also how long?
    Waiting for the lives of countless

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