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Thread: Comment on the SCINetUSA phase I/II and III trials

  1. #11
    Prof. Young I find that what you are explaining is very rational and I agree with that approach.

    I belive also that many people with SCI will find it a little discouraging as many of us probably would like to hear that a therapy restored near normal function in chronic rats and that tomorrow clinical trials are going to start.
    Others would like just to make sure that the therapy that is going to be tested is "the one" out of ten that works.
    It is an emotional game we can't avoid. Emotion (from latin "to move") is what drive most people actions.
    I guess many of us need to be educated also on our emotions to accept the cure process and work for it.

    Paolo

  2. #12
    Dr. Young,

    Thank you for your articulate and pragmatic approach. One question I have is whether or not hand function will be assessed. I understand that locomotion training is provided and that locomotive therapy has clear criteria to define progress. Will there be any training e.g arm bike, grasp e-stim, pushup-like assessment?

    A concern for many living with quadriplegia is as you know hand function. My physician of rehabilitative medicine told me that hand function is harder to recover then locomotion. I'm not sure why this is so. His opinion was based upon years of experience. Is there any scientific or neurological explanation for why arm and hand function would be harder to restore?

    Thank you again for your time and Herculean efforts.

  3. #13
    Quote Originally Posted by Chaz19 View Post
    Dr. Young,

    Thank you for your articulate and pragmatic approach. One question I have is whether or not hand function will be assessed. I understand that locomotion training is provided and that locomotive therapy has clear criteria to define progress. Will there be any training e.g arm bike, grasp e-stim, pushup-like assessment?

    A concern for many living with quadriplegia is as you know hand function. My physician of rehabilitative medicine told me that hand function is harder to recover then locomotion. I'm not sure why this is so. His opinion was based upon years of experience. Is there any scientific or neurological explanation for why arm and hand function would be harder to restore?

    Thank you again for your time and Herculean efforts.
    Chaz,

    As explained, the reason why we have to focus on the legs is because this trial will include both thoracic and cervical spinal cord injury and walking is the only standardized outcome that is common between paraplegics and quadriplegics. We will be getting overall motor scores of all the subjects at 6 weeks, 6 months, and a year after injury. Half of the ASIA motor scores are related to the upper limbs. So, we will have a rough measure of hand function. The primary outcome measure of the study will be the change in motor scores.

    I agree with your rehabilitation doctor that walking will be easier to restore than hand function. There are three bodies of evidence that support this view.

    The first is the so-called central cord syndrome. As you may know, this is a condition where the hand function are worse than the legs. It is called a central cord syndrome because people use to speculate that the damage is to the central part of the spinal cord where presumably the gray matter for the hands are located. More recent work by Dick Bunge, et al. suggesting that central cord syndrome is not as much damage to the central gray matter as it is the lateral column white matter. The point is that walking does not require as much white matter as hand function.

    The second is the discovery of the central pattern generator or CPG in humans. While the CPG has long been known to be present in animals, it was not demonstrated in humans until about the 1990's. The CPG can be activated by relatively few descending axons. It then can execute programmed movements such as walking, running, hopping, skipping, trotting, etc.

    The third is finding that over 90% of people who have "incomplete" spinal cord injury are able to recover independent walking. This is really quite a finding and one that one would not expect unless one only needs few axons to achieve walking.

    Wise.

  4. #14
    Quote Originally Posted by Wise Young View Post
    thoracolumbar injures (T11-L1), and non-traumatic spinal cord injuries.
    Marvelous idea. This means us, Lyniffer.

  5. #15
    Quote Originally Posted by skeaman View Post
    thanks for that
    so let me get this right hopeful phase 111 is over and result is good it than goes to FDA in 2011 do you know how long will they will sit on it be four it comes to us point is it is years keep going buy the good thing is it is start and if it was to come that quick it would stop ones going over seas i do hope it is not all talk it would be nice for them to keep us up dated what is going on so it can gave us hope
    Skeaman, the requirements are two phase III trials that the FDA agrees will show efficacy of the therapy. We are therefore doing two trials. One in China and one in the U.S. We will be registering both trials with the U.S. FDA.

    One has to discuss the trials with the FDA to make sure that the outcome measures fit with what that FDA believes are reasonable. It is possible that the FDA may require a functional outcome. It is also possible that they would want us to compare the treatment group against what they consider to be appropriate controls.

    How long it will take for approval depends on the results. If the results are what the FDA agrees would show efficacy and the treated groups meet the criteria for efficacy, the FDA may approve pretty quickly but an approval requires several other things besides a clinical trial to show efficacy.

    The FDA will want to ensure that the product (i.e. cells is what we say that it is, inspect the manufacturing process, and determine that it meets GMP or good manufacturing practices). This should be reasonably quick because the umbilical cord blood cells are being provided by a company that is already highly certified for cell transplantation.

    It is hard to tell. If everything is in order, an approval within a year after the clinical trial could happen.

    Wise.

  6. #16
    Quote Originally Posted by edlee View Post
    How is are the cells/lithium to be administered? Intrvenous,, into the spinal fluid,, above/below injury site? And how long post injury is the criteria to be?

    I'm sorry if these questions have been answered before in other threads, but I'm new here and thought going with "todays posts" would be less of an imposition on others.
    ed
    The cells are injected into the spinal cord above and below the injury site. The lithium is given orally. There is no limit of the time after injury, only a limit on age. Wise.

  7. #17
    Dr. Young, what if a patient meets the criteria but has a complete transection of the cord. Are they still eligable?
    Donnie: Dr. Xiao, What are your thoughts on a cure/combination therapy for SCI's??
    CG Xiao: Donnie, I don't want to disappoint you, but I think it is impossible to restore the continuity of the cord or "bridge the gap" in the near future, let's say: 50 years. Dr Wise Young has been my most respected scientist in SCI. He has dedicated and contributed to SCI no other can match.

  8. #18
    Quote Originally Posted by Donnie View Post
    Dr. Young, what if a patient meets the criteria but has a complete transection of the cord. Are they still eligable?
    This is up to the judgment of the investigator. At least at the present, we do not specify a transfection as an exclusion. Please note that physical transections are very rare and doctors often apply the term rather loosely. With perhaps the exception of bullet in the canal or other penetrating wounds of the spinal cord, transections are so rare that I don't think that I have ever seen one. It is true that something may look like a transection in the MRI but there is usually still some cord there when you go in surgically and look.

    It can be argued that a transected spinal cord is a very different condition from regular MVA-induced spinal cord injury and that perhaps we should do something to bridge the spinal cord instead of just injecting cells above the below the injury site. It is, however, such a rare condition that I don't think that it will have much effect on our trial. It also means that it may be difficult to carry out a separate trial of this condition because it is relatively rare.

    Wise.

  9. #19
    I was told by 5 different doctors that my cord was transected because of the large piece of vertabral body that travelled through the canal. This was what they saw through CT scan. It is my understanding that those show bone and therefore there could still be cord intact. I went through the op report and it never said the cord was transected just that the vertabral body retropulsed through the canal which was taken out during surgery. Is there a MRI machine that is high tech enough to see the cord and if so does Mayo Clinic have one?
    Donnie: Dr. Xiao, What are your thoughts on a cure/combination therapy for SCI's??
    CG Xiao: Donnie, I don't want to disappoint you, but I think it is impossible to restore the continuity of the cord or "bridge the gap" in the near future, let's say: 50 years. Dr Wise Young has been my most respected scientist in SCI. He has dedicated and contributed to SCI no other can match.

  10. #20
    Senior Member Imight's Avatar
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    How are the ChinaSCINet Linthium trials (2a?) coming along and have trial 2b started yet with HLA-matched cord blood mononuclear cells ? If so, how are they coming along? promising?

    Ps. Spinal Cord patients in Chengdu are in badly need of your assistance.

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