Thread: ChinaSCINet Update

  1. #1391
    Dr. Wise - 5 questions , please disregard if answered already.
    - How many days till we see results published?
    - Is US Trial totally jeopardized with 1 doctor / investigator absence?
    (aside from that we know for financing issue and FDA approval)
    - Trial in Norway on schedule?
    - Kunming paper is huge - how to convince world to adopt procedure fast?
    - How about Incomplete injuries inclusion in trial or ...?
    thanks!
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  2. #1392
    Quote Originally Posted by ay2012 View Post
    Dr. Young,
    I have a couple questions that I'm sure will show the layman in me but I was wondering if you could help. You've said that it might be too early, even at six months or a year, to gauge the functional benefits that could occur with these treatments, as the white matter would have to grow up and down the cord. Wouldn't it just be sufficient for growth across the injury site? Also, if we're banking on continued growth for functional return, beyond six months to a year, shouldn't we also be wary of jumping to conclusions regarding safety at these time frames? Or is that just a risk that appears not that great? Thanks as always.
    ay2012,

    Sensory axons must grow from below the injury site to the brainstem before they can restore function. Motor axons must grow from above the injury site to the lumbosacral spinal cord before they can restore movement. If recovery occurs any faster, it would be because there are existing axons that are crossing the injury site that have sprouted.

    Regarding safety, we are looking for complications due to surgery and the transplanted cells. If the cells have grown into a tumor, we expect to see an effect within 6 months. Of course, we would have to wait longer to see any slow effect but we can safely conclude that we see no evidence of any tumor induced or other significant neurological loss associated with the surgery.

    Wise.

  3. #1393
    Quote Originally Posted by Barrington314mx View Post
    This kind of reminded me of my weary thoughts i get when i hear "white matter growing UP the cord to the brain". Sounds scary to me.
    That is what regeneration is. White matter are myelinated spinal tracts. Wise.

  4. #1394
    Quote Originally Posted by allenstevens View Post
    "I am worried that if we don't have a intensive locomotor training program in the U.S., we will not see any locomotor recovery." Wise, I know a place real close to home where I met you that has a system you speak of Also the question about the baclofen pump any input for that ? Thanks
    I don't know (and don't think) that intensive locomotor training alone will help. I am referring to locomotor training after regenerative therapy. Regarding the baclofen pump, I am not sure. We have no experience with transplanting the cells in people with baclofen pump. I would think that we would want to keep it in but to check it regularly to make sure that the spasticity is not declining and the dose can be reduced.

    Wise.

  5. #1395
    Quote Originally Posted by comad View Post
    Dr. Wise - 5 questions , please disregard if answered already.
    - How many days till we see results published?
    - Is US Trial totally jeopardized with 1 doctor / investigator absence?
    (aside from that we know for financing issue and FDA approval)
    - Trial in Norway on schedule?
    - Kunming paper is huge - how to convince world to adopt procedure fast?
    - How about Incomplete injuries inclusion in trial or ...?
    thanks!
    Comad,

    1. The publication will not be for months. We are planning to submit the papers in January. Even in the unlikely case that it is accepted by the first journal that we submit to, it is likely to take 3-4 months. If we have to get it to other journals, it would take 6 months.

    2. Are you referring to the Phase 3 trial? If so, the loss of one center would not be a problem. However, in the case of the Phase II trial in Brackenridge, we have to find another principal investigator. Of course, we still have to raise th funds.

    3. The trial is Norway is the Phase III trial which is scheduled for Q3 2013. We still have to submit the IND and get the commitment of th Norwegian government to cover the costs. But, yes, I hope and believe that we are on schedule.

    4. Kunming paper will be published separately from the Hong Kong paper, which focuses on DTI. The Kunming paper will focus on neurological and locomotor recovery. I myself do not know the results yet. I will find out when I get to Hong Kong shortly after Christmas.

    5. I suspect that we will not be including motor incomplete patients in the trials in 2013. The reason is because their inclusion will increase the size of the trial, which we cannot afford at the present.

    Wise.

  6. #1396
    Quote Originally Posted by Wise Young View Post
    Comad,

    1. The publication will not be for months. We are planning to submit the papers in January. Even in the unlikely case that it is accepted by the first journal that we submit to, it is likely to take 3-4 months. If we have to get it to other journals, it would take 6 months.

    2. Are you referring to the Phase 3 trial? If so, the loss of one center would not be a problem. However, in the case of the Phase II trial in Brackenridge, we have to find another principal investigator. Of course, we still have to raise th funds.

    3. The trial is Norway is the Phase III trial which is scheduled for Q3 2013. We still have to submit the IND and get the commitment of th Norwegian government to cover the costs. But, yes, I hope and believe that we are on schedule.

    4. Kunming paper will be published separately from the Hong Kong paper, which focuses on DTI. The Kunming paper will focus on neurological and locomotor recovery. I myself do not know the results yet. I will find out when I get to Hong Kong shortly after Christmas.

    5. I suspect that we will not be including motor incomplete patients in the trials in 2013. The reason is because their inclusion will increase the size of the trial, which we cannot afford at the present.

    Wise.
    We will not be able to see any of the information I results until it is officially published?

    What is the cost per patient? What is the total that needs to be raised for ASIA A only? What would it take to see a few C's included? Dollar wise?

  7. #1397
    Senior Member lunasicc42's Avatar
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    Quote Originally Posted by Lyerly View Post
    We will not be able to see any of the information I results until it is officially published?

    What is the cost per patient? What is the total that needs to be raised for ASIA A only? What would it take to see a few C's included? Dollar wise?
    Yes, I was under the impression that we would hear results sometime this month... Is that correct?
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  8. #1398
    Quote Originally Posted by Wise Young View Post
    That is what regeneration is. White matter are myelinated spinal tracts. Wise.
    But what stops them from growing? Or how do they know when to stop? Maybe i watch too many weird movies. I get a picture of over grown ivy taking over my brain.

  9. #1399
    dr wise
    i though axons only need to connect on each side of the lesion,sensory or motor to establish function?

  10. #1400
    Quote Originally Posted by Wise Young View Post
    ay2012,

    Sensory axons must grow from below the injury site to the brainstem before they can restore function. Motor axons must grow from above the injury site to the lumbosacral spinal cord before they can restore movement. If recovery occurs any faster, it would be because there are existing axons that are crossing the injury site that have sprouted.

    Regarding safety, we are looking for complications due to surgery and the transplanted cells. If the cells have grown into a tumor, we expect to see an effect within 6 months. Of course, we would have to wait longer to see any slow effect but we can safely conclude that we see no evidence of any tumor induced or other significant neurological loss associated with the surgery.

    Wise.
    Dr. Young,
    Thanks for the response and sorry to press the issue, but could you provide some reasoning or even just literature as to why you would assume that the six month time frame would be sufficient to tell if a tumor would grow. I'm sure you've thought that through, but its the most common response I hear from people, even people in the rehab community, top physiatrists, heck even my main doctors in acute care as to why one should be weary for participating in trials and stem cell therapies more generally. Obviously these people aren't at the forefront of the research but it'd be nice to have a response to them.

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