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Thread: Clinical Trials

  1. #141
    Senior Member spidergirl's Avatar
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    Quote Originally Posted by Wise Young
    Perhaps somebody should start a new topic entitled Clinical Trials 2008. Alternatively, I can rename this thread. May I suggest that it is not true that there were no successful breakthroughs in 2007. The finding the cethrin improves recovery in people with spinal cord injury was announced in 2007.

    I have heard rumors that hp184 did not meet their expected primary outcome measure and the new Sanofi-Aventis has decided to can the therapy. In perhaps a month or two, Acorda Therapeutics will announce the second phase 3 result for Fampridine treatment of MS. If positive, this may lead to FDA approval of Fampridine.

    ChinaSCINet finished its phase 1 trial of lithium in 20 patients with chronic spinal cord injury. It suggests that the drug can be reliably titrated to therapeutic levels within about a week, does not cause significant adverse events, and appears to be relatively well-tolerated by people with chronic spinal cord injury.

    Well, there weren't many other clinical treatment trials that we can talk about. The Christopher and Dana Reeve Paralysis Act is still held up by Senator Coburn of Oklahoma for some reason that he has not been kind enough to share. The NIH is still spending less than 1% of its budget on stem cell research. In fact, this year, California will be spending over $300 million on human embryonic stem cell research, more than NIH is spending all human stem cell research, including umbilical cord blood and mesenchymal stem cells.


    Some animal spinal cord injury has been funded by NIH. So, there were a couple of significant breakthroughs there. Lipitor was found to be beneficial for acute spinal cord. This is really the first drug that may be as good or better than methylprednisolone and therefore should be a candidate for clinical trials.

    Induced pluritpotent stem cells were discovered in Japan, first in mice and then in humans. A group in Wisconsin and a group in Kyoto published simultaneously, reporting the forced expression of three genes in human skin cells can cause the cells to adopt embyronic stem cell like behaviors, including production of many different kinds of cells.

    A private group in San Diego announced that they successfully cloned several human blastocysts with a reasonable success rate. This is likely to lead to the announcement of the first cloned human embryonic stem cell line. California has started funding human embryonic stem cells and I think that there will be much progress on the West Coast, progress that can and should have been going on for the past 8 years.

    People are expecting miracles from loaves of bread.

    Wise.
    Dr. Young,

    My gut feeling here on the West Coast is acutes. I have met and interacted enough here to know.

    I think all the new break-throughs are great but we must be realistic here. All this is are pieces of the big puzzle.. We are several years away from a cure for chronics.

    I believe as much as I can and continue to move on with my life, raising much awareness.

    How do you feel about places like Cyberkinetics and Total Record who are not using stem cells? How do you feel about technological advances with spinal cord injury? I am kinda at a point where I believe in technology over science. (only bc science has been diregarded for years and people have and will always be fascinated with technology).

    After 2 years though, I see how this whole thing has not been taken to another level politically in the United States. It is "us" and not "them". We are not making a big enough impact in the United States because a majority of people in chairs are just trying to cope with their life let alone get out there and do something.
    Birds Fly in Flocks, but Eagles Fly Alone...

  2. #142
    Quote Originally Posted by spidergirl
    Dr. Young,

    My gut feeling here on the West Coast is acutes. I have met and interacted enough here to know.

    I think all the new break-throughs are great but we must be realistic here. All this is are pieces of the big puzzle.. We are several years away from a cure for chronics.

    I believe as much as I can and continue to move on with my life, raising much awareness.

    How do you feel about places like Cyberkinetics and Total Record who are not using stem cells? How do you feel about technological advances with spinal cord injury? I am kinda at a point where I believe in technology over science. (only bc science has been diregarded for years and people have and will always be fascinated with technology).

    After 2 years though, I see how this whole thing has not been taken to another level politically in the United States. It is "us" and not "them". We are not making a big enough impact in the United States because a majority of people in chairs are just trying to cope with their life let alone get out there and do something.
    Cheryl,

    Thanks for posting and I apologize sincerely for the delay in answering you. I just got back from Washington DC, from the warm glow of so many families pushing their politicians to do the right thing. It was heartwarming and heartbreaking at the same time. You have been there and you know what I mean.

    Melissa Pitts cried at the Congressional briefing. She was crying not out of sorrow for her sons. I think that they were tears of frustration. What nobody noticed was that Melissa's mother was holding Ron (Alex's brother) in her arms and she was also crying. That was when my heart broke. I was afraid somebody would see all the turmoil in my heart.

    Melissa said that she had to learn patience. My patience is running out. Why is it that we are still on Capitol Hill on bended knee asking for something that should have been done a long time ago? Dumb it down, people were telling us. I have now been going to Washington every year for 15 years, sometimes several times a year.

    Please don't get me wrong. I am not giving up. Not in the slightest. I am just no longer willing to wait while others make the decision. Government funding is our Plan A. A while back, I decided to implement Plan B, doing the trials overseas while we are waiting for the support in the United States. Now, we are going ahead with Plan C. We'll do the clinical trials in the U.S.

    By the way, we are doing it for chronics.

    Wise.

  3. #143
    Senior Member Quadcessible's Avatar
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    Quote Originally Posted by Wise Young
    Cheryl,

    Thanks for posting and I apologize sincerely for the delay in answering you. I just got back from Washington DC, from the warm glow of so many families pushing their politicians to do the right thing. It was heartwarming and heartbreaking at the same time. You have been there and you know what I mean.

    Melissa Pitts cried at the Congressional briefing. She was crying not out of sorrow for her sons. I think that they were tears of frustration. What nobody noticed was that Melissa's mother was holding Ron (Alex's brother) in her arms and she was also crying. That was when my heart broke. I was afraid somebody would see all the turmoil in my heart.

    Melissa said that she had to learn patience. My patience is running out. Why is it that we are still on Capitol Hill on bended knee asking for something that should have been done a long time ago? Dumb it down, people were telling us. I have now been going to Washington every year for 15 years, sometimes several times a year.

    Please don't get me wrong. I am not giving up. Not in the slightest. I am just no longer willing to wait while others make the decision. Government funding is our Plan A. A while back, I decided to implement Plan B, doing the trials overseas while we are waiting for the support in the United States. Now, we are going ahead with Plan C. We'll do the clinical trials in the U.S.

    By the way, we are doing it for chronics.

    Wise.
    Dr. Young,
    All I can simply say is, "Thank You"

  4. #144
    Quote Originally Posted by Wise Young
    Now, we are going ahead with Plan C. We'll do the clinical trials in the U.S.

    By the way, we are doing it for chronics.

    Wise.
    Somewhat off topic, but will you be starting the trials over, or picking
    up where you left off? If i've read right, you have already completed lithium trials in China.

  5. #145
    Quote Originally Posted by Buck_Nastier
    Somewhat off topic, but will you be starting the trials over, or picking
    up where you left off? If i've read right, you have already completed lithium trials in China.
    Depending on the phase 2 results and regulatory requirements, hopefully phase 3. Wise.

  6. #146
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    Dr. Young,
    Any projected timeframes yet?

    And also, a very heart felt THANK YOU.

    mark

  7. #147
    Senior Member Schmeky's Avatar
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    Spidergirl,

    You made a comment several months ago stating you thought robotics or something similar would benefit us first. You may have been right since an exoskeleton is currently undergoing clinical trials with completion and availability of an exoskeleton scheduled for sometime in 2009. If it is feasible, this is the route I will probably take.

    The political climate in the USA for large scale funding is still not ripe for SCI clinical trials. Perhaps if there is a Dem in the White House chances will certainly be better, but with the current fiscal mess Bush has created for us, SCI funding will be a very low priority.

  8. #148
    Quote Originally Posted by mthomson
    Dr. Young,
    Any projected timeframes yet?

    And also, a very heart felt THANK YOU.

    mark
    We are just starting. I hope that we can raise the funds and get the trial going in 2009. Wise.

  9. #149
    Quote Originally Posted by Schmeky
    Spidergirl,

    You made a comment several months ago stating you thought robotics or something similar would benefit us first. You may have been right since an exoskeleton is currently undergoing clinical trials with completion and availability of an exoskeleton scheduled for sometime in 2009. If it is feasible, this is the route I will probably take.
    Not me, my friend. The idea of wearing some exoskeleton suit is a
    real turn-off.

    I remember you making this remark about an experimental procedure
    being tested by Dr. Herman.

    Quote Originally Posted by Shmecky
    When an electrical current was applied, the person could stand and walk like Frankenstein. It was a hideous sight, something that would scare the hell out of a class of 4th graders. It was interesting, but primitive to say the least.
    I can't imagine what wearing an exoskeleton would look or feel like.
    Last edited by Buck503; 04-17-2008 at 07:48 PM.

  10. #150
    Senior Member Schmeky's Avatar
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    Quote Originally Posted by Buck_Nastier
    Not me, my friend. The idea of wearing some exoskeleton suit is a
    real turn-off.

    I remember you making this remark about an experimental procedure
    being tested by Dr. Herman.



    I can't imagine what wearing an exoskeleton would look or feel like.
    You're referring to something very different. The "Frankenstein" comment I made was in reference to the treadmill/central pattern generator retraining in conjunction with an impressed current applied to the spinal cord.

    The exoskeleton is not the same. There is probably limited applicability in the real world with an exoskeleton. Time will tell.
    Last edited by Schmeky; 04-19-2008 at 02:26 PM.

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