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Thread: Functional incompelete Quads and Dr.Wise trial results.

  1. #1
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    Functional incompelete Quads and Dr.Wise trial results.

    Hello community,

    I just read all the information in regards to recent trial result. I understand the empirical data from trials and I must say I am intrigued for the lack of better word. It brings a question to my mind.

    How would highly functional quad react to the same procedure? There are many cases of SCI that experienced return of function below injury site to some degree. For instance Brown-Séquard syndrome.

    I understand the reason why incompletes are skipped in trials but perhaps it would be an interesting experiment to throw in some incomplete injuries into the mix of phase 3 trials.

    Its only a speculation of an inexperienced mind of mine but I think its logical to expect already semi-functional SCI's to benefit from the procedure, maybe even to bigger extent then Asia A patients. There is also a question whether Incompletes will benefit from decompression alone.

    Of course, I am not an expert and I could be missing something. Forgive me If i do. I feel a bit selfish even asking because I know there are people that need it much more then I do but I cannot help to over analyze. I represent a group that got somewhat lucky in that we got lots of function back but we still have a long way to improve. Given the expected number of subjects, I think its not unreasonable to ask for some representation in phase 3 trials.

    What do you guys think? I ask for some speculation and ideas.

    Dr.Wise, would you care to address my concerns?
    Last edited by BSgimp; 06-05-2013 at 01:40 PM.

  2. #2
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    BS, I have produced function all the way to toes in each leg. Even BM. Do have problem with urine. Only thing I know there is I must go. If I keep myself from getting "excited" internally, I have no problem getting to toilet. As for feet, I have produced "extension" of foot. Still need strength building, but this does a ton for walking. Using the foot does things I cannot even describe to help walk. I still need to produce "retraction" of foot. I think. Am working on that or just simply extremely weak. As for most of your suggestions, I do not know what they are. All function I now am producing is 10+ year post injury.

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    Quote Originally Posted by rlmtrhmiles View Post
    BS, I have produced function all the way to toes in each leg. Even BM. Do have problem with urine. Only thing I know there is I must go. If I keep myself from getting "excited" internally, I have no problem getting to toilet. As for feet, I have produced "extension" of foot. Still need strength building, but this does a ton for walking. Using the foot does things I cannot even describe to help walk. I still need to produce "retraction" of foot. I think. Am working on that or just simply extremely weak. As for most of your suggestions, I do not know what they are. All function I now am producing is 10+ year post injury.
    I am happy for you. Glad to read you are still recovering after 10 years. Best of luck to you. I know there are many in similar situations, some more advanced, some less fortunate. Even though I suspect it is minority group I believe we should be represented in further phases of the trials despite the fact it would be difficult to prove the true circumstances of recovery, given there will be one. Perhaps the results will be a positive surprise.

  4. #4
    In the trial in switzerland for example they are enrolling patients now with incomplete injurys and many studies which are going on right now are doing the same. I think (not knowing = Wise?) in incomplete injurys you can do much more damage to the tissue that is somehow still together and for me it sounds locigal to test the ´´completes´´ first because you get better data from those.

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    BS, with incomplete, there is no way to calculate the amount of strength lost over time even in areas not injured simply by not doing exercise for the "uninjured" areas that work like "along for the ride." I also think over time without the exercise your body and brain learn differently. To return that stuff, you now need to "break" the incorrect learned by sitting around. I did this by turning eyes off - closing them. And performed things mentally before ever even trying physically.

  6. #6
    Clinical trials must be designed to show statistically significant results. Because the phase II trial showed that 75% of the UCBMC-transplanted patients recovered ability to walk in a rolling frame with minimal manual assistance and we expect that probably no more than 10-20% of untreated complete (ASIA A) chronic spinal cord injured people to recover similar walking, we can reduce the number of subjects needed to show a statistically significant effect. This saves money and time.

    After the phase III trial is done and if it shows significant effects, all that we have to do is a phase II trial to show safety, feasibility, and similar beneficial effects to get an expansion of the indications. For surgical therapies, such as this, surgeons really have the option to apply the procedure to whatever patient that they think will benefit. This will get the therapy to patients faster and more cheaply than doing a randomized 400 subject trial that includes ASIA A, B, and C.

    Wise.

    Quote Originally Posted by BSgimp View Post
    Hello community,

    I just read all the information in regards to recent trial result. I understand the empirical data from trials and I must say I am intrigued for the lack of better word. It brings a question to my mind.

    How would highly functional quad react to the same procedure? There are many cases of SCI that experienced return of function below injury site to some degree. For instance Brown-Séquard syndrome.

    I understand the reason why incompletes are skipped in trials but perhaps it would be an interesting experiment to throw in some incomplete injuries into the mix of phase 3 trials.

    Its only a speculation of an inexperienced mind of mine but I think its logical to expect already semi-functional SCI's to benefit from the procedure, maybe even to bigger extent then Asia A patients. There is also a question whether Incompletes will benefit from decompression alone.

    Of course, I am not an expert and I could be missing something. Forgive me If i do. I feel a bit selfish even asking because I know there are people that need it much more then I do but I cannot help to over analyze. I represent a group that got somewhat lucky in that we got lots of function back but we still have a long way to improve. Given the expected number of subjects, I think its not unreasonable to ask for some representation in phase 3 trials.

    What do you guys think? I ask for some speculation and ideas.

    Dr.Wise, would you care to address my concerns?

  7. #7
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    Quote Originally Posted by Wise Young View Post
    Clinical trials must be designed to show statistically significant results. Because the phase II trial showed that 75% of the UCBMC-transplanted patients recovered ability to walk in a rolling frame with minimal manual assistance and we expect that probably no more than 10-20% of untreated complete (ASIA A) chronic spinal cord injured people to recover similar walking, we can reduce the number of subjects needed to show a statistically significant effect. This saves money and time.

    After the phase III trial is done and if it shows significant effects, all that we have to do is a phase II trial to show safety, feasibility, and similar beneficial effects to get an expansion of the indications. For surgical therapies, such as this, surgeons really have the option to apply the procedure to whatever patient that they think will benefit. This will get the therapy to patients faster and more cheaply than doing a randomized 400 subject trial that includes ASIA A, B, and C.

    Wise.
    Thank you Dr.

    I understand now. So in order to include other types of injuries we would have to take a step back to phase II for all the unique types of injury. Not only that but including them in phase III would affect the validity of statistical data. I imagine the data from incomplete injuries would be more inconclusive and difficult to measure.

    Can't wait for data from phase III trials. It is going to be imperative if we are to hope for beneficial procedure in near future. I remain to be an optimist and would like to thank everyone that is involved with all my heart. Like my hero Feynman once said experiment is a key to science. And looking at the data from phase II it is difficult not to get your hopes up.

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    Truthfully, I know nothing I-III and same A-C. I do not even know what they are. HOWEVER, you comment of "take a step back..." has been exactly what I do when I think I am "stuck" - making no progress fro extended period of time. The answer always has been 1 of the following. 1 - I may have missed something. OR 2 - I AM taking too big of a jump forward. In #2, I did not miss anything to get to where I was, HOWEVER I am stepping over things in the forward process.

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    Quote Originally Posted by Wise Young View Post
    Clinical trials must be designed to show statistically significant results. Because the phase II trial showed that 75% of the UCBMC-transplanted patients recovered ability to walk in a rolling frame with minimal manual assistance and we expect that probably no more than 10-20% of untreated complete (ASIA A) chronic spinal cord injured people to recover similar walking, we can reduce the number of subjects needed to show a statistically significant effect. This saves money and time.

    After the phase III trial is done and if it shows significant effects, all that we have to do is a phase II trial to show safety, feasibility, and similar beneficial effects to get an expansion of the indications. For surgical therapies, such as this, surgeons really have the option to apply the procedure to whatever patient that they think will benefit. This will get the therapy to patients faster and more cheaply than doing a randomized 400 subject trial that includes ASIA A, B, and C.

    Wise.
    Wise, So everyone with an incomplete sci will have to wait for a additional phase II trial (assuming phase III shows significant improvements)? Whats to stop the patient or doctor from just not telling the truth and getting the treatment anyway? How would anyone tell especially for an Asia B.

  10. #10
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    LHB, when I was in therapy, COMMUNICATION was so poor I cannot describe. My ears were wrecked with medication. END RESULT, in therapy, since communication was so poor, I seriously doubt, whatever they were trying to do and what I thought they were telling was SO drastically different, nothing was accomplished. I recognize this 10+ years after accident. Was in water therapy, therapist actually believed I could not hear or understand, an low and behold, she took whiteboard into pool with us. Damn magic Here and I WERE ON THE SAME PAGE. Shit actually started working. Take it, there is tons more to story, but FINALLY what therapist was doing, what I was saying, what I was doing and probably many other things ALL "EQUALLED" each other.

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