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Thread: Did anyone here get to attend yesterdays open house?

  1. #21
    Is this latest presentation available online anywhere or is there another one coming up soon? Thanks

  2. #22
    Apparently the first rule of open house club is you don't talk about open house, lol.
    "I'm manic as hell-
    But I'm goin' strong-
    Left my meds on the sink again-
    My head will be racing by lunchtime"

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  3. #23
    There's not much to report since Wise posted this a month ago-

    Quote Originally Posted by Wise Young View Post
    The decision of who should be in a trial will be made by the investigators at each center. The protocol stipulates inclusion and exclusion criteria. After that, once the patients meet the criteria, the decision depends on the investigator who has to weigh risk, suitability, likelihood of followup, and other factors in the decision. From the perspective of the trial inclusion and exclusion criteria, it is possible that you may not fit because you may be ASIA B or C, neurological level may be C3 or C4 (the lowest intact level), and the lesion length may extend 2 segments. To date, our trials have specified ASIA A, C5-T11, and lesion length ≤2 segments.

    However, for the phase IIb trials, we are considering expanding the inclusion criteria to ASIA A, B, and C and neurological level of C4 to T11. We have not discussed the possibility of including patients with lesion lengths that are greater than 2 segments. The reason is because it would require a 4 level laminectomy to expose the spinal cord above and below the injury site to transplant the cells. Such a long laminectomy increases the risk of instability and we don't feel that this risk is warranted until it is clear the the treatment is effective. It is not clear that you would qualify for the trials even under the expanded inclusion/exclusion criteria.

    On the other hand, exclusion from the trial does not mean that the treatment will not be beneficial for you. We are planning to apply for compassionate use of the therapy by qualified doctors when the phase III trial is approved. This would mean that if you are able to find a qualified doctor to apply the therapy and locomotor training, that doctor can obtain the cells to apply to you at cost. The cost of the cells will be negotiated by the regulatory agency (e.g. US FDA) with the company. This, however, is not likely to happen until the phase III trial starts, perhaps mid-2016.

    The major question that we are debating now is whether ASIA B and C should be included in the phase IIb. I believe that people who are stable ASIA B and C chronic SCI do not recover very much without therapy and therefore should be candidates for the trial. However, some of the investigators believe (legitimately in my opinion) that the trial would be much more credible if all the subjects were complete, i.e. ASIA A, like it was in our trials to date. Unfortunately, we are finding that relatively few people with chronic SCI are ASIA A.

    Contrary to what is published, we find that many people have anal sensation and motor function below the level of injury, even though they were originally ASIA A. I am using the term ASIA rather than AIS (ASIA Impairment Scale) because people may not recognize AIS. I am suggesting that we should use the opportunity of this phase IIb trial to compare the response of complete and incomplete patients to the treatment. It would be important to know whether or not the therapy improves people with ASIA B and C, in addition to A.

    Before we did our phase I and II trials in Hong Kong and Kunming, we could not have chosen people who are ASIA B or C because doctors were afraid that transplantation of the cells into the spinal cord may cause of the loss of some function. However, so far, we have not observed neurological loss in any of the patients, even though we have transplanted cells into the spinal cord above the injury site (where sensory and motor function are intact). I think our safety data to date justifies the inclusion of ASIA B and C. This is a decision that our investigators must come to a consensus on.
    Wise.

    Congressional Briefing, Washington, DC, Tuesday, June 23rd
    Dr. Young has been invited to give a Congressional Briefing on Capitol Hill for members of Congress and their staffs. Dr. Young will share the results of the clinical trials and the importance of bringing these trials to the United States.

    Please write to your Senators and Representatives and urge them to attend: Tuesday, June 23rd, 2-3:00, Cannon Office Building, #121.

  4. #24
    Senior Member Moe's Avatar
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    Quote Originally Posted by Jim View Post
    There's not much to report since Wise posted this a month ago-

    Congressional Briefing, Washington, DC, Tuesday, June 23rd
    Dr. Young has been invited to give a Congressional Briefing on Capitol Hill for members of Congress and their staffs. Dr. Young will share the results of the clinical trials and the importance of bringing these trials to the United States.

    Please write to your Senators and Representatives and urge them to attend: Tuesday, June 23rd, 2-3:00, Cannon Office Building, #121.
    To me it would of been a lot more convincing and I'd be more excited if at least (after a year and a half waiting) that the Phase I&II data would of been published by now. Last I heard here was that the publication submissions were rejected by a few reputable journals for the reason of being 'too specialized'.Can we even talk about IIb&III without finalizing what was left off unfinished? Are the trials just as good even If the results can't get published into the medical journals?

  5. #25
    Quote Originally Posted by ineedmyelin View Post
    Apparently the first rule of open house club is you don't talk about open house, lol.
    The problem starts when you don't have real good news to report. Here is when people go silent. Then if one understands what's really going on and has the balls to face it you may hear something...
    Problem is that for us living the hell of SCI with little or no education about neuroscience it's almost impossible (for most of us) to understand what's really going on in the field.
    I would also say that for us living the hell of SCI with little or no education about neuroscience it is very easy to believe misleading informations.

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

  6. #26
    Senior Member Moe's Avatar
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    Quote Originally Posted by ineedmyelin View Post
    Apparently the first rule of open house club is you don't talk about open house, lol.
    Quote Originally Posted by paolocipolla View Post
    The problem starts when you don't have real good news to report. Here is when people go silent. Then if one understands what's really going on and has the balls to face it you may hear something...
    Problem is that for us living the hell of SCI with little or no education about neuroscience it's almost impossible (for most of us) to understand what's really going on in the field.
    I would also say that for us living the hell of SCI with little or no education about neuroscience it is very easy to believe misleading informations.

    Paolo
    RELAX - He's referring to a movie quote in case you didn't get the joke and STOP saying 'WE' - speak for yourself cuz I don't think like the way you just described so learn how to say "I" instead.

    Correction:"Problem is that for I living the hell of SCI with little or no education about neuroscience it's almost impossible (for me) to understand what's really going on in the field.
    I would also say that for I living the hell of SCI with little or no education about neuroscience it is very easy to believe misleading informations."
    (btw, I didn't get why you had to repeat similar sentences)
    Last edited by Moe; 06-18-2015 at 08:17 PM.

  7. #27
    Senior Member lunasicc42's Avatar
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    Quote Originally Posted by paolocipolla View Post
    The problem starts when you don't have real good news to report. Here is when people go silent. Then if one understands what's really going on and has the balls to face it you may hear something...
    Problem is that for us living the hell of SCI with little or no education about neuroscience it's almost impossible (for most of us) to understand what's really going on in the field.
    I would also say that for us living the hell of SCI with little or no education about neuroscience it is very easy to believe misleading informations.

    Paolo

    I interpret it different...I presume that if he is going to a government council to present his findings to Hopefully get more funding; he must have something good to present or it wouldn't be worth the effort
    "That's not smog! It's SMUG!! " - randy marsh, southpark

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  8. #28
    Quote Originally Posted by Moe View Post
    RELAX - He's referring to a movie quote in case you didn't get the joke and STOP saying 'WE' - speak for yourself cuz I don't think like the way you just described so learn how to say "I" instead.
    I am relaxed don't worry

    "We" just means "more than one person", I didn't mean to include you

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

  9. #29
    Quote Originally Posted by lunasicc42 View Post
    I interpret it different...I presume that if he is going to a government council to present his findings to Hopefully get more funding; he must have something good to present or it wouldn't be worth the effort
    Your interpretation is reasonable, mine is just different.
    In God we trust; all others bring data. - Edwards Deming

  10. #30
    Senior Member lunasicc42's Avatar
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    Quote Originally Posted by paolocipolla View Post
    Your interpretation is reasonable, mine is just different.

    I mean there would be no reason to go there without something good to report...what is your interpretation?
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


    2010 SCINet Clinical Trial Support Squad Member
    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

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