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Thread: How To Enroll In Wise Young's Trials

  1. #11
    Quote Originally Posted by jody View Post
    I have been wondering what individual costs would be to get into trials.
    Nobody should pay for offering his/her body for experiment
    not only did i not pay a single cent, but accomodation, flights meals taxi service for me and my care giver where paid by stem cell inc and this was only for a screening test.
    Last edited by peterf; 06-28-2012 at 03:33 PM.

  2. #12
    Quote Originally Posted by Wise Young View Post
    In Hong Kong, the cost of the trials was partly supported by the government and the trials were intended only for people who are Hong Kong residents. In addition to the inclusion and exclusion criteria, we ask the investigators to excluded candidates who are unlikely to come back for followup exams. As I explained earlier, if a person does not come back for followup, this really messes up our trials. We are investing a huge amount into each subject and, if that subject doesn't come back for followup, this would be a big loss for us.

    The classification and neurological level required for inclusion is at the time of the screening examination for the trial. Neurological level is defined as the lowest contiguous level with intact motor and sensory function. So, if you are T12, you would not fit the eligibility criterion for the trial.

    Wise.
    Isn't people at levels in the low Ts mixed with lower and upper motor neuron? I have flaccid leg muscles but a crazy spastic bladder. Gonna be pretty tough to handle if your therapy shows promising results and you can be to low to use it and see benefit.

  3. #13
    Quote Originally Posted by Lyerly View Post
    Isn't people at levels in the low Ts mixed with lower and upper motor neuron? I have flaccid leg muscles but a crazy spastic bladder. Gonna be pretty tough to handle if your therapy shows promising results and you can be to low to use it and see benefit.
    Lyerly, that is correct. The lumbar cord begins around vertebral segment T10 and extends to vertebral T12. The sacral cord is at vertebral level L1. So, if your neurological level is T11 (i.e. T11 is intact), this means that your injury is affecting T12 spinal cord and below.

    We are aiming for lumbosacral spinal cord injury in our 2014 trials, i.e. people who have injuries to their T11. We are starting the animal experiments now to develop a model of lumbosacral spinal cord injury and we are testing cell transplants, lithium, and axonal growth inhibitor blockers (Cethrin and possibly others).

    Wise.

  4. #14
    Jody,

    A legitimate clinical trial should not be charging patients for experimental therapies. The US FDA has changed the rules somewhat to allow clinical trials to charge for therapies that have proven value in clinical trials but not for the experimental therapy. However, any charges must be approved by the U.S. FDA as well as the institutional review boards. For example, we might be able to make the argument that locomotor training is beneficial and ask the patients to pay for that portion of the trial but not for the experimental part, which is the umbilical cord blood cell transplant and lithium.

    The other possibility is for us to design the clinical trial around patients who need surgery for some reason, i.e. syringomyelia, and then transplant the cells while the spinal cord is exposed. That was what Ed Wirth and his colleagues did at University of Florida in Gainesville about a decade ago when they were injecting fetal spinal cord tissues into the spinal cord. Since the surgery for syringomyelia is required, one can charge for that and the addition of cell transplants would be a freebie.

    Another example is what Lisa McKerracher and Bioaxone did with Cethrin. They had the surgeon apply the Cethrin to the dural surface of patients who were getting laminectomy to expose the spinal cord after trauma. This essentially reduced the cost of the clinical trial to the cost of the drug and the examination of the patients. However, since the laminectomies were done in the first week after injury, the treatment was given only during the subacute phase of spinal cord injury.

    In our case, however, since we are planning to do the surgery on chronic spinal cord injury, we must pay for the surgery. We are also planning to provide intensive locomotor training for at least 6 weeks. Together the cost of the surgery and the rehabilitation will add up to about $100,000 or more in the United States. That is what makes a chronic spinal cord injury trial much more expensive than an acute spinal cord injury trial.

    Wise.

  5. #15
    Quote Originally Posted by Wise Young View Post
    Lyerly, that is correct. The lumbar cord begins around vertebral segment T10 and extends to vertebral T12. The sacral cord is at vertebral level L1. So, if your neurological level is T11 (i.e. T11 is intact), this means that your injury is affecting T12 spinal cord and below.

    We are aiming for lumbosacral spinal cord injury in our 2014 trials, i.e. people who have injuries to their T11. We are starting the animal experiments now to develop a model of lumbosacral spinal cord injury and we are testing cell transplants, lithium, and axonal growth inhibitor blockers (Cethrin and possibly others).

    Wise.
    You are still including as low as T11 as far as I remember?

  6. #16
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    I would be overwhelmed to regain blatter & bowel function in any of these trials. I understand intense rehab for walking, but what would be needed to concentrate only on bowel & blatter? Also why not just target that category for now? Just wondering.

  7. #17
    Quote Originally Posted by JoeMonte View Post
    but what would be needed to concentrate only on bowel & blatter? Also why not just target that category for now? Just wondering.
    so if we can only have either walking or bowel and bladder, who gets to decide what and why? i for one would rather walk normally again over bowel and bladder return.

  8. #18
    Quote Originally Posted by Lyerly View Post
    You are still including as low as T11 as far as I remember?
    Yes, in our current trials, this is so. Wise.

  9. #19
    Quote Originally Posted by JoeMonte
    I would be overwhelmed to regain blatter & bowel function in any of these trials. I understand intense rehab for walking, but what would be needed to concentrate only on bowel & blatter? Also why not just target that category for now? Just wondering.
    Quote Originally Posted by Barrington314mx View Post
    so if we can only have either walking or bowel and bladder, who gets to decide what and why? i for one would rather walk normally again over bowel and bladder return.
    JoeMonte and Barrington,

    Please, this is silly. It is not a matter of our choice what people recover. The treatment may restore walking or bowel/bladder function, or both. However, we must choose a primary outcome measure for the trial. We happen to choose walking because we know that most people who are incomplete will recover walking.

    Wise.
    Last edited by Wise Young; 06-29-2012 at 10:31 AM.

  10. #20
    Senior Member mcferguson's Avatar
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    Quote Originally Posted by jody View Post
    I have been wondering what individual costs would be to get into trials.
    for those of us who work, the only cost will be our time away. bills gotta get paid.
    T5/6, ASIA A, injured 30 Nov 08
    Future SCI Alumnus.
    I don't want to dance in the rain, I want to soar above the storm.

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