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Thread: ChinaSCINet Update

  1. #941
    My specific comments are embedded and my general comments follow.

    Quote Originally Posted by paolocipolla View Post
    Wise,

    I'l try to be more clear on sevral points.

    1) I didn't say that recruitment of chronic spinal cord injury patients is easy.
    I agree it is still a lot of work, but think it is much easier than with acute SCI as you have an existing population with chronic SCI that can travel etc..
    About the Hong Kong trial you had been able to recuit just 8 patients in two years because you couldn't accept patients non Hong Kong resident.
    @ I agree.

    I think it was a mistake to run a trial in a place wher you can't accep patients from other countries. Many CC members are willing to parteciapate to your trial and willing to come back for examinations when needed, but they can't because you can't accept patients from around the world. I think it is quite clear that to accelate SCI clinical trial for chronic SCI at this stage it very important to have a center that can accept candidates from around the world.
    @ Why would the Hong Kong government pay for treatments of patients from other countries? You have the cart before the horse. If we had a billion dollars to do the trial, perhaps we can do something like that what you suggest. Otherwise, we have to follow where opportunity leads us and circumstances restrict us to do.


    2) I have 2 questions here:
    How many patients per arm would you need in a phase III ACUTE SCI
    trial?
    How many patients per arm would you need in a phase III CHRONIC SCI trial?
    This is of course what phase 2 trials are intended to find out. We would need to estimate the variability (i.e. standard error of mean) of treated and control populations and then do a power analysis to find out how many subjects are needed to detect X percent change in the outcome measure. We know from the methylprednisolone trial that about 60 subjects per treatment arm were necessary to detect 10% differences in motor and sensory score changes. We don't yet have that data from our phase 2 trials. I am hoping that that number will be lower for chronic ASIA A subjects.


    3) You say:
    "Will everybody who travels to join a clinical trial be ready to give up 3 months of their lives and to return again at 6 months and a year (or more) after the treatment? Some might but I suspect that many would not be able to do it."
    Ask for a deposit to the partecipants before they join the trial.
    Interesting idea. I am not sure that institutional review boards would approve such a proposal. They would approve, however, a payment incentive, i.e. pay subjects to come back. Again, this is a question of funding and not a question of possibility.

    4) You say:
    "You assume that the results of a single trial center would be credible to the rest of the world."

    Well if you have enrolled patients with Thoracic SCI, with no function below the level of injury and now some of them are walking I belive it shoud NOT be difficult to convivnce doctors the the therapy is working.

    @ The Kunming group did a study showing that approximately 50% of 30 subjects with ASIA A recovered ability to walk unassisted when they were treated with intradural decompression. The study did not do a control. Over half of the subjects had ASIA A thoracic spinal cord injuries. The study was turned down by the two major neurosurgery journals. The reviewers said that they did not believe the results, which is tantamount to saying that they thought we were lying.

    Even when the results were published by a multicenter study from the United States, doctors may not believe. Take a look at the National Acute Spinal Cord Injury Study (NASCIS II), where we did a double-blind randomized placebo-controlled trial involving 487 subjects published in the New England Journal of Medicine (the most prestigious medical journal in the world). During the two years that followed publication of that study in 1990, less than a third of patients with acute spinal cord injury in the United States received the high-dose methylprednisolone (MP) therapy. It took several years of concerted effort to increase the usage rate of MP to 90% by the mid-1990's. But, once that effort slackens, doctors stop using the drug, even though there has been no new information from clinical trials indicating that the drug is ineffective or unsafe. Today, less than 50% of spinal cord injured patients in the United States and Europe are receiving MP. In 1991, the investigators of NASCIS decided that the data was too strong to allow us to conduct a second placebo-controlled trial of MP. The FDA requires two phase 2 randomized controlled trial for approval of a therapy. In some ways, I wish that we had gone ahead to a second phase III trial and gotten the spinal cord injury approved as an indication for MP. Many thousands of patients would have received the drug and gotten an average of 20% better recovery. But, such a trial would have been impossible to do after the publication of the first trial.

    Let me give you another example from another field. Jaing, et al. from the Chang Gung Memorial Hospital in Taiwan (one of the best and most respected hospital in Taiwan) published a paper in 2010 reporting that he had 88% survival and disease-free survival in 74% of 35 kids with thalassemia treated with umbilical cord blood from Stemcyte. Thalassemia is a genetic disease that is easily documented. In 2011, Ruggeri, et al. from Italy published a study which reported the European experience using umbilical cord blood from multiple cord blood banks and they found only 67% total survival and 23% disease-free survival in 35 kids of thalassemia. Ruggeri, et al. recommended that umbilical cord blood cells not be used to treat kids of thalassemia except in a clinical trial setting. These kinds of differences happen amongst clinical trials. Many doctors around the world still refuse to use umbilical cord blood to treat thalassemia, even when they cannot find HLA-identical siblings to donate bone marrow, relegating the child to a life-time of blood transfusions every two or three weeks, along with all the expense and complications that such frequent transfusions bring.


    I also assume you can show medical examinations (done by indipendent examiners) of the patients before and after the treatment with the motor scores etc., or the medical community will considere your claims at the level of the ones of Geeta Shroff end others (NO COMPARISON INTENDED HERE).
    In our Hong Kong trials, we had OT/PT examiners at each hospital as well as well as third-party examiners at the MacLehose rehabilitation center. In Kunming, we have designated nurse-doctor teams of experienced examiners (who are actually going to the homes of the patients to examine them because many cannot come back to the hospital for the followup exams). Credibility is not easy to achieve.

    Finally I want phase III trial of therapies that can restore significant functions, not something that has the same efficacy of pacebo even less,
    That is the pharma business and I am not intersted in that.
    @ What you want is not always what you get in trials. Of course, all of us would love to see significant functional improvements from a therapy. I don't know where you get the impression (as indicated by your signature quotes) that "pharma business" wants something less. In fact, approval of third party re-imbursement for therapies now require not only significant evidence of improvement but the improvement must be meaningful. So, let me assure that pharmaceutical industry want treatments that produce functionally significant improvement.


    Paolo

    Clinical trials have two purposes. The first if of course to show that treatments are safe and effective. The second is to show that the treatments are not safe or are not effective. The latter should not need to be said but people (including most scientists and clinicians) forget this. Right now, many medical tourism clinics around the world are offering umbilical cord blood cell therapy of spinal cord injury, pointing to animal studies that show efficacy. If our trials show that umbilical cord blood mononuclear cells transplanted into the injury site, with or without lithium, do not change neurological function in patients, we can say definitively that the therapy does not work and recommend against its use. On the other hand, if the treatment does work, either with or without lithium, we want to be able to strongly recommend its use and back up that recommendation with global phase III trials.

    Phase II trials are not sufficiently powered to be statistically convincing. On the other hand, they can show trends and, based on those trends, I believe that it is worthwhile going ahead to phase III trials. You will see the data from the trends as soon as all the data is collected and we submit the data for publication. Usually journals allow scientists and clinicians to share data before publication in symposia but premature publication of the data on internet may harm the chances of the data being accepted for publication in the best possible journal. That is the reason why I cannot present the data here.

    Wise.
    Last edited by Wise Young; 06-28-2012 at 01:09 AM.

  2. #942
    Dr. Wise,

    When discussing the different groups in the Open House presentation, you mention that the fifth group, the group receiving UCBMC+MP+Li, were only at their six week stage and implied it was too early to really say anything about their progress. This group would be at about the ten week stage now. Perhaps it is still too early to say, but can you broadly indicate at all how this group is doing?

    I've been coming to this forum for years and it has been a constant source of encouragement. Thank you so much for all the time and energy you've spent helping people and trying to fix spinal cord injury. It is amazing.
    Last edited by crabbyshark; 06-30-2012 at 05:35 PM.

  3. #943
    Junior Member
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    Chronic incomplete lower thoracic lumbar

    Dear Dr Young

    First of all I wold like to just thank you for all your hard work and dedication to the cause. You are an inspiration and a hero to me. I truly believe that good things are coming in the near future.

    I am a t12 or L1/L2 incomplete. Ive been told different things b different doctors. I think based of my movement, sensation I'm more likely L1/L2

    I walk with crutches full time. I have braces for ankle support as I have no strength below my knees, though I do have some sensation.

    I am now 10 post injury due to a GSW, which they originally said severed the cord.. But they were obviously wrong

    What are the chances that I would be eligible for your therapy, either in a phase 3 trial or later in the future.

    Thank you again

    James Paik

  4. #944
    Quote Originally Posted by keeping on View Post
    Y8,IF cure has been claimed in china, I woul dthink that this would be broadcast over the world and made available all over the world. the walking that Paolo mentioned has to be defined. Is it acutes or chronics. Is it something never seen before or is a result of wise's treatment.
    I understnad the Hong Kong thing. I also see the differnce incost between china, Switzerland, and the USA. this is one of the beifits that will be accrued with Obama;s Affordabel Health . wise has been reluctant to tell what has been achieved except safety. Dr Silver has a therpay he might try, years away from clinical trial, and disagrees with wise's ideas and findings. the board only want s a successful trial that will be available ot us in the near future.

    anthony
    It reminds me of Howard Cosell's career and commentary.


  5. #945
    Quote Originally Posted by crabbyshark View Post
    Dr. Wise,

    When discussing the different groups in the Open House presentation, you mention that the fifth group, the group receiving UMBMC+MP+Li, were only at their six week stage and implied it was too early to really say anything about their progress. This group would be at about the ten week stage now. Perhaps it is still too early to say, but can you broadly indicate at all how this group is doing?

    I've been coming to this forum for years and it has been a constant source of encouragement. Thank you so much for all the time and energy you've spent helping people and trying to fix spinal cord injury. It is amazing.
    Crabby, we are waiting for the 6 month followup. They are formally examined at 6 weeks, 6 months, and 12 months. That data will be available in November. Thank you for your comments and it is indeed an exciting time. Wise.

  6. #946
    Quote Originally Posted by Oocofficial View Post
    Dear Dr Young

    First of all I wold like to just thank you for all your hard work and dedication to the cause. You are an inspiration and a hero to me. I truly believe that good things are coming in the near future.

    I am a t12 or L1/L2 incomplete. Ive been told different things b different doctors. I think based of my movement, sensation I'm more likely L1/L2

    I walk with crutches full time. I have braces for ankle support as I have no strength below my knees, though I do have some sensation.

    I am now 10 post injury due to a GSW, which they originally said severed the cord.. But they were obviously wrong

    What are the chances that I would be eligible for your therapy, either in a phase 3 trial or later in the future.

    Thank you again

    James Paik
    James,

    The spinal cord ends below L1. The examination and diagnosis of injury to the lower spinal cord is quite complex and most doctors are not sufficiently experienced to do that examination properly. I have a few questions.

    How is your bladder function and anal sphincter? If you have anal sphincter tone and your bladder is spastic, this suggests that your conus (the tip of the spinal cord) is intact. In that case, you may have injured the spinal cord just above the conus (which is at L1) or the cauda equina below the conus.

    Do you have sensation in your T12 dermatome? I attach a picture of the dermatome. How is your sensation in the L1, L2, L3, L4, and L5 dermatomes? This will give you a clue as to where your injury is and whether it involves the spinal cord or cauda equina.

    Wise.

  7. #947
    dr.wise, like many others have said you and your team are the things that keep us going. Thank you so much for all your hard work and dedicatoin to this research I will be looking forward to november to see the results. For now all we can do is keep in shape and pray.

  8. #948
    Quote Originally Posted by allenstevens View Post
    dr.wise, like many others have said you and your team are the things that keep us going. Thank you so much for all your hard work and dedicatoin to this research I will be looking forward to november to see the results. For now all we can do is keep in shape and pray.
    Allenstevens, you are very welcome. There is a huge amount of work to do and the encouragement from you and others is very important not just for me but for the team. Wise.

  9. #949
    Thank you for your response Dr. Wise. I have another question. Are the results of the study going to be published in November or is that when you all are submitting the data for review?

  10. #950
    Quote Originally Posted by crabbyshark View Post
    Thank you for your response Dr. Wise. I have another question. Are the results of the study going to be published in November or is that when you all are submitting the data for review?
    We plan to submit the manuscript as soon as we get the data. Wise.

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