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Thread: Spinal Cord Injury Network USA (SCINetUSA)

  1. #531
    Please excuse me for repeating the question. Jim, do you know if the patients in the China study regained use of their trunk muscles? I read the paper and didn't find any reference to it.

  2. #532
    That is awesome news Jim! What day was it submitted so that we can all rage on day 90 that we haven't heard anything yet? Is that 90 business days or calendar days?

  3. #533
    Quote Originally Posted by rmarks70 View Post
    Please excuse me for repeating the question. Jim, do you know if the patients in the China study regained use of their trunk muscles? I read the paper and didn't find any reference to it.
    rmarks, sry, didn't see your question up there. The only way to give an accurate answer would be to look at the patient's ASIA exams. I do not have access to those.


    Quote Originally Posted by khmorgan View Post
    Personally, I don't think that is a bad question at all. It seems to me that most of the current treatments establish minimal communications between the brain and the undamaged part of the spinal column. Then through intensive therapy, they reactivate the Central Pattern Generator in the undamaged spinal column allowing walking and some bowel and bladder functional improvement. I may be completely wrong, but I haven't heard of the treated patients getting improved arm and finger movement, improved breathing (i.e. improved ability to blow and cough using chest muscles), feeling, etc.

    But, don't take my word for things. I've pretty much given up. I've been a C5/6 for over 50 years and expect to die this way.
    In order to regain function in hands, fingers, or any muscle for that matter, IMO, it must be exercised. Function will not just magically return. In the upcoming trial we will use stimulators for hands/fingers. It will be interesting to see if this works. We have much to learn.

    Quote Originally Posted by Barrington314mx View Post
    That is awesome news Jim! What day was it submitted so that we can all rage on day 90 that we haven't heard anything yet? Is that 90 business days or calendar days?
    Haa, no countdowns.

    We can hold off celebrating until all the surgeries are performed without incident.

  4. #534
    Senior Member khmorgan's Avatar
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    Quote Originally Posted by rmarks70 View Post
    Thanks Khmorgan,

    You may be right as I am just learning about spinal cord injuries. But it seems to me that for someone to be able to walk in a walker or even do locomotor therapy the way it was described in the China study that the patient would need to have control of their trunk muscles.
    Again, just my opinion, I agree that when walking, you must either have a brace or use of your trunk muscles. I think that the CPG likely controls not only the legs and feet muscles, but also the trunk muscles. That is, when you walk, run, or jump, do you consciously move your abdominal and back muscles? Probably not. Therefore, they are probably controlled by the CPG. Perhaps this is why the arms and hands are not restored by current stem cell treatment. They are not as dependent on the CPG, therefore not restored when it begins functioning again.

    Certainly, exercise after stem cell treatment is absolutely critical, but exercise doesn't fully answer the question of "What happened to restoration of sensation?"

    There is so much that we don't know. I sincerely hope that researchers will someday understand exactly how the human neuromuscular system works and how to fully restore it when it is damaged. Now, I feel like current cures are just stabbing in the dark, hoping to find something that works.

  5. #535
    @Jim , what is the possibility of higher cervical injuries (C3-4 in my case) being eligible for the mononuclear cord blood treatment pending the FDA 90-day approval that we await? Can you also advise if having any other stem cell treatment that may alter the injury site (considering atm to alleviate neuropathic pain) may have a negative affect for this later treatment?

    Hats off for the wonderful progress Wise & team are making.
    Last edited by Pauly1; 04-27-2018 at 02:43 PM.

  6. #536
    Quote Originally Posted by Pauly1 View Post
    @Jim , what is the possibility of higher cervical injuries (C3-4 in my case) being eligible for the mononuclear cord blood treatment pending the FDA 90-day approval that we await? Can you also advise if having any other stem cell treatment that may alter the injury site (considering atm to alleviate neuropathic pain) may have a negative affect for this later treatment?

    Hats off for the wonderful progress Wise & team are making.
    Pauly, the phrenic nerve mostly originates at C4. For that reason, neurosurgeons are reluctant to inject there. Wise plans to have a separate trial for high quads. Instead of injecting above and below the injury site, inject below and into the top part of the injury. This all has to be worked out. I'm speculating, but don't think the FDA will allow this to be elgible for Compassionate Use before being testied in it's own trial.

  7. #537
    Senior Member Moe's Avatar
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    Quote Originally Posted by Jim View Post
    When we get the ok from the FDA (within 90 days) I will post instructions how to apply. You will apply directly to the hospital performing the surgery.
    When is the exact due date really? is it a sure thing this time or just an assumed prediction? any more pages needed to ad for submission or there's enough? When you say within 90 days on 04-24-2018, that means no later than JULY 24th 2018... Right?
    Last edited by Moe; 05-10-2018 at 01:42 PM.
    "Talk without the support of action means nothing..."
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  8. #538
    Quote Originally Posted by Moe View Post
    When is the exact due date really? is it a sure thing this time or just an assumed prediction? any more pages needed to ad for submission or there's enough? When you say within 90 days on 04-24-2018, that means no later than JULY 24th 2018... Right?
    When dealing with the FDA, or any federal bureaucracy, there is no due date. Sorry to say but the 90 day limit that they are supposed to adhere to is more for our ears than their priority. What do you think will happen if they go over the 90 days? Fired? Fined? Reprimanded? Nope. There will be no consequences for them if they fail to meet a deadline - and they know it. It'll happen when it happens. Hopefully sooner than later, but with the FDA I would not be counting the days.


  9. #539
    Senior Member Moe's Avatar
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    Quote Originally Posted by tumbleweeds View Post
    When dealing with the FDA, or any federal bureaucracy, there is no due date. Sorry to say but the 90 day limit that they are supposed to adhere to is more for our ears than their priority. What do you think will happen if they go over the 90 days? Fired? Fined? Reprimanded? Nope. There will be no consequences for them if they fail to meet a deadline - and they know it. It'll happen when it happens. Hopefully sooner than later, but with the FDA I would not be counting the days.
    Respectfully I addressed the question to Jim in regards to his post. Maybe someone else involved personally in US Phase IIb can answer since Dr Wise doesn't get involved in this forum anymore?

    FDA is the excuse for the US... What about Norway and India? FDA Stopping them too? How come China not going forward with future trails since they thought was so successful? Oh yes it was because stemcyte no longer provides cord blood to China or something like that posted earlier.... Chinese pregnant women don't naturally produce cord blood therefor they can't carry on with this research... (sarcasm)

    oh I like this one: four years later still no followup on the patients from previous trials because "they are too far"
    Last edited by Moe; 05-10-2018 at 08:06 PM.
    "Talk without the support of action means nothing..."
    ― DaShanne Stokes

    ***Unite(D) to Fight Paralyses***

  10. #540
    We are very pleased with the FDA, they have been very helpful and a pleasure to work with.

    Moe, no one is making excuses, trials are very hard to pull off, especially in three new clinical trial networks around the world, at the same time. We don't yet have a clinical trial network in Norway, Wise hasn't had the time to go there and organize it. After ChinaSCINet completed the Phase II trail (3 years ago) the government declared cells would no longer be allowed to be imported. (Wise has since started a company in Hong Kong to collect and process cord blood. All of his profits will be put into a SCI Fund for US research/clinical trials.) Around that time Wise set up a clinical trial network in Taiwan, they will be taking part in the IIb trials. Shortly after this was announced, China lifted the restrictions on importing cells. The plan is to involved them in the Phase III. A network has also been set up in India, they will also take part in the IIb trial. They started the walking program a few months ago.

    The three year follow up has not been done yet because the money is being raised and logistics worked out. And yes, many of the patients live in areas that are not accessible by car, so teams have to be sent to them.

    I know sci sucks, but that's not an excuse to be an ungrateful prick.

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