Thread: ChinaSCINet Update

  1. #1451
    Quote Originally Posted by Wise Young View Post
    Pelican,

    I am not sure what you mean by "locomotor training" but I use the term locomotor training to refer to overground walking. Perhaps you are thinking of locomotor training as weight-supported treadmill training. If so, let me emphasize none of the subjects in our studies have had any treadmill training. They start with overground walking.

    There are two serious limitations to weight-supported treadmill training. First, weight support harnesses place significant pressure on certain body parts, such as the straps that go between the legs) and carry a significant risk of pressure sores and walking time must be limited to an hour or less at a time. Second, due of the weight support, the walking is abnormal and the sensory cues for the legs are incorrect. It is like teaching the person to walk on the moon and then having to reteach the person how to walk on the earth when transferring to overground walking. The group in Kunming believes that walking should be done with full-weight bearing from the beginning.

    When I first visited Kunming in 2004, I am surprised by how fast the people start to step and walk without assistance when they get the training starting 2 weeks after their spinal cord injury. Many (particularly incomplete or complete patients who received the intradural decompression) recovered walking within 3 months. However, people with chronic spinal cord injury do not recover as fast and almsot all reach a plateau within 3 months.

    To the best of my knowledge, our current trial is the first time that the Kunming group has been systematically training a significant cohort of patients with chronic spinal cord injury with their 6:6:6 overground walking program after cell transplants. Incidentally, several of the patients currently in Kunming are training but without having received any transplants, so they constitute a form of control.

    While some of the subjects (about 25%) in our study showed improvements during the first 3 months, we are now seeing subjects that showed little improvement during the first 3-6 months but are getting locomotor function late at 6-12 months. Please withhold judgment on the walking until you have actually seen the data and the walking. I cannot present the detailed data or videos here without attracting criticism from people like Jerry Silver but I think that you will be surprised.

    I have been observing spinal-injured people doing locomotor training for several decades. In the 1980's, for example, Barbara Devine headed a group that trained people with spinal cord injury to walk 7 or more hours every day. She had dozens of people walking in her facility in Cottonwood, Alabama and then later in Galveston, Texas. In my opinion, very few got functional walking back. I am seeing locomotor recovery that I have not seen before. Be patient. We will get the work published.

    Wise.
    Wise, I agree that overground walking training will be much more effective than weight assisted treadmill training.

    But, from what I have seen so far a walking programme alone will not really be enough for unassisted walking - no matter how how intensive. Surely there is more than just walking in the programme in Kunming? For example how are the trunk muscles, glutes and hamstrings being stimulated and conditioned appropriately? Maybe there is more to the programme that you havent described because unassisted walking needs a hell of lot of conditioning - something that you dont get by simply walking.

    Let me give you an example. I know a number of incomplete walkers who walk with crutches and canes very well. They walk all day long. Not just at home but everywhere. However, without stimulating, strengthening and some serious conditioning of the trunk, hamstrings and glutes they can never progress to unassisted walking.

    Is there perhaps more to the programme in Kunming than 6 hours of walking?

    Cheers

  2. #1452
    Quote Originally Posted by Fly_Pelican_Fly View Post
    Wise, I agree that overground walking training will be much more effective than weight assisted treadmill training.

    But, from what I have seen so far a walking programme alone will not really be enough for unassisted walking - no matter how how intensive. Surely there is more than just walking in the programme in Kunming? For example how are the trunk muscles, glutes and hamstrings being stimulated and conditioned appropriately? Maybe there is more to the programme that you havent described because unassisted walking needs a hell of lot of conditioning - something that you dont get by simply walking.

    Let me give you an example. I know a number of incomplete walkers who walk with crutches and canes very well. They walk all day long. Not just at home but everywhere. However, without stimulating, strengthening and some serious conditioning of the trunk, hamstrings and glutes they can never progress to unassisted walking.

    Is there perhaps more to the programme in Kunming than 6 hours of walking?

    Cheers
    Pelican,

    I share your view. Most people with ASIA A spinal cord injuries reach a low plateau in their walking and more walking, no matter how intensive, will not get them beyond that plateau. Of course, you get an occasional person who never seriously tried walking and may even be incomplete that will show dramatic improvement with training. But, in general, intensive locomotor training does not restore unassisted walking to people with chronic ASIA A spinal cord injury.

    We don't have a non-transplanted group of chronic spinal cord injury patients in this study. However, there are some patients at Kunming now who are not part of the study but are training without having received any cell transplnats. Also, this is an escalating dosing study where dose of cells injected increased. When we complete analysis of the data, we will correlate recovery with the dose and HLA-matching of cells.

    In our study, the subjects averaged 12 years after injury and none were able to walk without assistance before the treatment. All were ASIA A. Although some (25%) showed improved locomotor scores without motor score changes within 6 months, most (75%) of them showed only slight or no improvements in locomotor scores after 3 months of training. Now, some subjects are showing delayed locomotor recovery at 6-12 months.

    I want to emphasize that this is a phase II study. It was designed to ascertain whether the treatment is safe, feasible, and improves recovery of some patients. So far, the study results indicate that the therapy is safe. It certainly appears to be feasible. Finally, it improves recovery in some of the subjects, even though it was only 3 months after treatment.

    The study showed several unexpected findings. First, MR/DTI showed fiber bundles growing across the injury site at 6-18 month after cell transplants. Second, even by 3 months some subjects (25%) showed improved locomotor scores. Third, at 6-12 months, we are seeing delayed locomotor recovery in some subjects.

    The data suggest that the bundles of fibers and the improvements in locomotor scores result from the transplants. None of the subjects has had bundles of fibers crossing the injury site before transplantation. None showed such bundles <6 months after the treatment. At least in two subjects, the fiber bundles were growing longer between 6-18 months.

    Only a Phase III trial, a true double-blind randomized controlled trial will prove this. That is why we are pushing forward to do that trial in 2013.

    Wise.
    Last edited by Wise Young; 12-22-2012 at 02:42 PM.

  3. #1453
    Quote Originally Posted by Geoman View Post
    Paolo,
    I know you have good intentions, but getting bogged down with this is just semantics and not helpful in any way, and in fact may be detrimental due to the fact that Wise is now considering whether or not he will be providing us with any of the preliminary findings of the trial/s. It really just comes across that you're just feeding your own ego rather than genuinely trying to help the cause. If it's your "personal opinion" and it doesn't help our understanding, in future it's probably best to keep it that way..."personal" that is.

    Clayton
    While I agree with your general point, I think you're doing the same thing on another level. Who cares if Wise gives us preliminary results? The important thing is that the data gets published in a peer reviewed journal. Giving us prelim results is pointless and gets us no where. You are missing the forest for the trees.

  4. #1454
    Great question about the arms. The picture that I showed in http://sci.rutgers.edu/forum/showpos...postcount=1403 applies to the arms as well as the legs. We are collecting ASIA motor and sensory scores from the arms and the legs. In the arms, the ASIA standard examination includes five muscles: deltoids, biceps, wrist extensors, triceps, and wrist flexors. We did not include other hand function measures but plan to include them in the Phase III trial. We are hoping that we will see some improvements in those scores but I want to emphasize that less than half of the subjects in the Hong Kong and Kunming trial have cervical spinal cord injuries.

    Wise.





    Quote Originally Posted by Skipow View Post
    Dr. Wise,

    According to the model of nerve regeneration you provided, wouldn't the clinical trials show improved arm and hand function in cervical level injury subjects (C5 and below) at this point? What motor scores are being used to test upper level extremities? Is there arm therapy being used in this trial as well, or is this a consideration for phase 3 studies?

    Is this model for nerve regrowth a disagreed topic for SCI researchers as well, where the nerves just need to jump across the injury site or to the location of the nerve root?

    Everyone,

    I am really appreciative of top researchers discussing results on this web site and allowing open questions and discussion, but we should try to be more polite to one another. Critical questions are important and are great for understanding what is going on, but when people get negative towards one another and then talk about it more. It removes focus of why we even come to this forum. Both sides of the fence are not innocent here either. Lets stick to the point.

    It would be really interesting to go to a thread that is limited to researchers to discuss their opinions, ideas, and findings among one another, without the clutter of the general public, so it is condensed and easier to page through. Does this exist? Some of the best ideas are formed during the after hours of conventions where a bunch of researchers collaborate and debate their ideas, why not do this every day?! I'm sure it would speed up the rate of progress for SCI research. This would be really interesting to observe as well.

    Thanks! Merry Christmas!

  5. #1455
    Quote Originally Posted by Wise Young View Post
    Great question about the arms. The picture that I showed in http://sci.rutgers.edu/forum/showpos...postcount=1403 applies to the arms as well as the legs. We are collecting ASIA motor and sensory scores from the arms and the legs. In the arms, the ASIA standard examination includes five muscles: deltoids, biceps, wrist extensors, triceps, and wrist flexors. We did not include other hand function measures but plan to include them in the Phase III trial. We are hoping that we will see some improvements in those scores but I want to emphasize that less than half of the subjects in the Hong Kong and Kunming trial have cervical spinal cord injuries.

    Wise.
    Can you discuss preliminary outcomes in arm motor/ sensory improvement from this trial from the cervical subjects?

    Since the study seems to be safe in C5 subjects and below, will C4 or higher be considered for phase 3? Or does another phase 1 and 2 study need to be done to assess the safety of this procedure with C4 and higher?

    Thanks!

  6. #1456
    Senior Member Cspine's Avatar
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    I'm curious about hand and arm function as well. Walking is actually fairly low on my priority list. I have a little movement in my fingers and especially my thumbs, but it's more novel and not functional.
    Death and taxes

  7. #1457
    Quote Originally Posted by Chaz19 View Post
    I just wanted to comment, that I really appreciate this dialogue. It is very helpful, informative and does provide context to our problem. As a passive viewer, I value this discussion and wish many therapies could be discussed in this manner (without any personal attacks). Thanks to all for their contributions.
    Stop waiting for things to happen, Go out and make them happen.

    http://curegirls.wordpress.com/

  8. #1458
    Quote Originally Posted by Skipow View Post
    Can you discuss preliminary outcomes in arm motor/ sensory improvement from this trial from the cervical subjects?

    Since the study seems to be safe in C5 subjects and below, will C4 or higher be considered for phase 3? Or does another phase 1 and 2 study need to be done to assess the safety of this procedure with C4 and higher?

    Thanks!
    We are planning a phase II trial on high cervical injuries (C1-C4) to assess a different protocol where the cells are injected into the injury site and below in the injury site, rather than above and below the injury site. The reason why we restricted the current trial to C5 is because a C4 injury would require the that the upper (above the injury) injection be done at C3.

    We have not analyzed the data for recovery of the hand and arm function yet and so I don't know the results yet.

    Wise.

  9. #1459
    Senior Member Moe's Avatar
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    Quote Originally Posted by Wise Young View Post
    We are planning a phase II trial on high cervical injuries (C1-C4) to assess a different protocol where the cells are injected into the injury site and below in the injury site, rather than above and below the injury site. The reason why we restricted the current trial to C5 is because a C4 injury would require the that the upper (above the injury) injection be done at C3.

    Wise.

    I'm glad to learn that things are planned to move forward even for upper injuries. A read one of your posts regarding the safety for nerve fiber growth downwards and upwards for the c5 level… I’m glad that it has been proving good results on the safety data so far but my question to you is should we consider a much obvious higher risk for the c1-c2 level due to the location is much closer than a c5 to the brain? I’m curious and worried if somewhere up in the spinal cord there’s some kind of natural barrier preventing anything growing up in the skull… I understand that perhaps it’s too early to know but I’m curious of your point of view.

    I thank you very much for your hard work and appreciate the time you share with us!

    Cheers,

    Moe
    "Talk without the support of action means nothing..."
    ― DaShanne Stokes

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

  10. #1460
    So.... For those of us seeking any new kind of information, is there anything on the horizon we should check back here in a couple months for? I.e. update on the publishing process, organization or fundraising for the Phase III (in China and the US)? Thanks again.

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