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Thread: ChinaSCINet Update

  1. #931
    Quote Originally Posted by jsilver View Post
    Thanks Wise.

    Dear CC community,

    We are all in this together and until we help those with SCI get better we will not rest. Good heated scientific debate stirs passion and helps maintain our focus on what is really important...to develop real solutions to cure chronic spinal cord injury. I stirred the pot yet again. Ch'ase has, indeed, been shown to be effective after a contusive type of injury. Importantly, we will report shortly the development of a second generation and markedly improved strategy that works better than ch'ase to overcome CSPG mediated inhibition. The new therapy is highly effective in restoring function (locomotion and bladder function) after severe contusive injury using a simple, systemic route of administration. This time around we don't need Acorda and we have a much easier road to clinical trials. I still think I have a few good ideas left in this old brain and I have and will continue to dedicate most of what I think about to the SCI community.
    Thank you, sincerely. Some of the comments here must make you wonder if it's even worth it.

  2. #932
    Senior Member lunasicc42's Avatar
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    thank you IMHopeful

    We are going to w2w this year, I can't wait
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  3. #933
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    Smile

    Dr Wise Young,

    Thank you for your dedication in finding a cure for spinal cord injuries! I am a complete c5-c6 quad from a gun shot wound. Are any of your trials involving similar cases like mine? If so, where? If not, would you consider me as a candidate for stem cell therapy after the trial phases are completed, or, at anytime?

    Keep up the great work!

  4. #934
    Quote Originally Posted by Littlerosey36 View Post
    Dr Wise Young,

    Thank you for your dedication in finding a cure for spinal cord injuries! I am a complete c5-c6 quad from a gun shot wound. Are any of your trials involving similar cases like mine? If so, where? If not, would you consider me as a candidate for stem cell therapy after the trial phases are completed, or, at anytime?

    Keep up the great work!
    Littlerosey,

    One of the subjects in our Hong Kong trial had spinal cord injury from gunshot. Therefore, we have not been excluding such patients from our trials to date. I don't know whether we will or not in the phase 3 trial because that depends on the decision of the investigators. However, so far, we have not.

    Wise.

  5. #935
    I removed some posts to the Members Only Forum http://sci.rutgers.edu/forum/showthr...68#post1547468.

    Wise.

  6. #936
    Quote Originally Posted by Wise Young View Post
    Littlerosey,

    One of the subjects in our Hong Kong trial had spinal cord injury from gunshot. Therefore, we have not been excluding such patients from our trials to date. I don't know whether we will or not in the phase 3 trial because that depends on the decision of the investigators. However, so far, we have not.

    Wise.
    Sweet, I'am glad to hear that
    keep (rolling) Walking

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  7. #937
    Quote Originally Posted by Wise Young View Post
    Paolo,

    Let us examine each of the assumptions behind your far reaching conclusion that networks are not necessary:

    1. You seem to be assuming that recruitment of chronic spinal cord injury patients is easy. Let me assure you that it is not. Despite substantial effort and a great deal of publicity for two years, Hong Kong University and the Chinese University of Hong Kong were not able to find more than 8 chronic ASIA A patients that had neurological levels between C5 and T11. Even in Kunming, where they operate on over 400 acute spinal cord injury cases per year and where there is no dearth of acute or chronic patients, it took over 6 months to recruit and transplant 20 chronic SCI subjects. There are many reasons why individual patients may not fulfill inclusion and exclusion criteria, are not ready or available for the trials, or are not willing to take the risk, etc. I believe that we probably should not expect any individual center anywhere in the world except China to treat and assess more than 20 patients per year.

    2. The numbers of patients required for phase 3 trials are larger than you are assuming for the following reasons. First, you must have controls and multiple treatment groups. In the U.S., we will need to compare all components of a treatment against a combination before you can conclude that the combination is effective. In the case of UCBMC and lithium, this means that you need to have four treatment groups: rehabilitation only, rehabilition + lithium, rehabilitation + UCBMC, and rehabilitation + UCBMC + lithium. If you need 50 subjects per treatment group, that will require 200 subjects. Second, we must consider injury variables. So far, we are talking about only ASIA A subjects. Perhaps the treatment would work in ASIA B and C. Just including these two groups would triple the number of subjects. Third, we must consider treatment variables. For example, if we want to assess whether intensive locomotor training is necessary (the rehab alone group answers the question of sufficiency but not necessity), we would have to have UCBMC+lithium with and without locomotor training. If we want to know whether HLA-matching is necessary, i.e. compare HLA 4:6, 5:6, and 6:6 matches, a trial of 400 subjects would be required. Only a network can do trials of over 100 subjects.

    3. You are assuming that chronic spinal cord injury subjects will travel and return for followup exams and therefore clinical trial centers can be located anywhere. It is a good idea and I have in fact looked into this possibility of setting up a center in one place where many people would go. I grant you that many patients may be willing to travel. If it were only the surgery, it might even be possible to do a trial where the subjects come back for followup examinations. In my experience, however, many people do not keep their promises. There are many reasons why people do not come back, not the least of which is that it is expensive and time-consuming for somebody to travel long distances for examinations. Particularly if they do not think the treatment is working, they don't come back. Each subject represents investments of over $100,000 to treat in a clinical trial and if they do not come back for followup, that investment is lost. The requirement for intensive and prolonged rehabilitation may further restrict the number of subjects. Our preliminary data suggest that if you don't engage in intensive walking training, locomotor recovery will be limited. This factor alone is likely to severely limit clinical trial tourism. 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.

    4. You assume that the results of a single trial center would be credible to the rest of the world. I can assure you that this is not the case. I know of many groups that have done 20-50 subject trials and showed very promising results and then cannot get their results published in the best journals. The reviewers turn down the papers and say that they don't believe. The reviewers are tantamount to saying that the investigators are lying. To be credible, particularly in controversial or first-in-human therapeutic successes, you must have multicenter phase 3 trials to convince the rest of the world that the treatment is efficaceous.

    Finally, you cite Schwab and Buchli who are calling for more phase 1 and 2 proof-of-concept trials. I agree that we should have more phase 1 and 2 trials, but not at the expense of not doing phase 3 trials. Phase 3 trials are essential for proving efficacy and obtaining regulatory approval. Phase 1 and 2 trials are pre-coital, if you know what I mean. If we want therapies to be approved by the regulatory authorities, they must pass through phase 3 trials. We must do phase 3 trials if the treatments are to help people. Let me give you an example from the sports world. It would be like preparing a racing car to win all the time trials and get a good pole position but not having the funds to take the car to the final race. The phase 3 trial is not only the final race, it is the only race that counts. Multicenter trials are essential for phase 3 and networks are essential for efficient multicenter trials.

    Wise.
    Wise,

    I'll 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 think it was a mistake to run a trial in a place where you can't accept 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.

    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?

    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.

    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.
    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).

    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.

    Paolo
    Last edited by paolocipolla; 06-27-2012 at 06:51 PM.
    In God we trust; all others bring data. - Edwards Deming

  8. #938
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    Quote Originally Posted by paolocipolla View Post
    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.

    Paolo
    Then why don't you start such a clinical trial?

  9. #939
    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 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.

    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?

    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.

    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.
    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).

    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.

    Paolo
    1.hongkong trial is fund by Hongkongnese,one condition is Hongkong residents only.Well,by the way,Beijing has stem cell center welcomes other country patients.if u want to go,I can send information to u.
    3.It is not allowed to take deposit for join a clinic trial.
    4.Well,again,Beijing Wujing hospital had been claimed cured sci for a few years,but the data only in that hospital.

  10. #940
    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

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