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Thread: ChinaSCINet Update

  1. #341

    Red face

    Wouldn't it be great if these trials regrow enough fibres to get complete injured people walking? I mean, the spinal cord injured community could use a break and have some great medical news for a change!

  2. #342
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    Quote Originally Posted by Christopher Paddon View Post
    Wouldn't it be great if these trials regrow enough fibres to get complete injured people walking? I mean, the spinal cord injured community could use a break and have some great medical news for a change!
    Sure, try fix the change then… What is holding the community back?

  3. #343
    The community has been told there will never be a cure and you must get on with your lives. Getting on with your life takes a lot of energy and once some sort of life is established the idea doesn't seem to occur to many people - I mean, our doctors should be trusted.

    I have met one person in a wheelchair in New Zealand who believes in a cure although Noela Valis, whose husband was paraplegic, has fought tirelessly to get clinical trials started in Christchurch.

  4. #344
    Quote Originally Posted by Wise Young View Post
    sam,

    The decision to go ahead depends on the findings.

    1. If the phase 2 treatment shows that the treatment causes complications or is not effective, then you stop or change the procedure and retest in another phase 2 trial.

    2. Because phase 2 studies are typically not powered sufficiently (i.e. don't have enough patients to achieve statistical significance), the decision whether to proceed to a phase 3 depends on the results. The results may fall into three categories:
    • The therapy has no beneficial effects or even a deleterious effect that cannot be attributed to some problem with dose or delivery. In such a case, one would clearly not proceed.
    • The therapy has clear beneficial effects that are statistically significant even at phase 2 levels. In such a case, one would proceed to phase 3 but with fewer patients in the trials because the results should be robust.
    • The therapy is safe and there is a trend for benefit. In such a case, one would go ahead with the phase 3, probably with more patients in the trials in case the results occur only in a fraction of the patients or the effects are small.

    3. If the phase 3 trial shows that umbilical cord blood cells are significantly beneficial, then all subsequent therapies will be compared against that treatment because it would be the first and best therapy that restores function to chronic spinal cord injury.

    Wise.

    Thanks for replying Dr. Young.. from your response, it means that proceeding to phase 3 is even bigger news than we expected. Also, from my understanding, your phase 3 can host a big number of patients or a small number of patients depending on your phase 2 results, right?

    Thanks again and good luck and I hope that 2013 will have something ready for us.

  5. #345
    We are holding workshops and consensus conferences to look at new therapies. Whether umbilical cord blood mononuclear cells (UCBMC) and lithium are effective or not, we will need to look for new therapies. If UCBMC+lithium restores function, we need to look at other therapies, such a neural stem cells and see if they are better than UCBMC+lithium. Other possibilities include the olfactory ensheathing glia (OEG) and perhaps combinations of UCBMC and OEG. There is also the possibility of iPS or induced neuronal progenitors (iNP), etc. We may consider combining UCBMC+lithium and nogo antibody, chondroitinase, nogo receptor blocker, cethrin, and other axonal inhibitor blockers.

    On May 5-8, 2012, at the Fifth International Spinal Cord Injury Treatment and Trials Symposium (ISCITT5) and International Association of Neurorestorology (IANR) in Xi'an, we will be inviting several companies that have cells that are ready for clinical trials to present to us. So, we are systematically looking for new candidate therapies to compare against UCBMC+lithium to test in 2013.

    Wise.

  6. #346
    Wise, would you consider, if all went well, having a therapy go into 'general' use, for example the cord blood and lithium treatment you are testing now, while carrying on testing other therapies?

    I think what I am thinking is that cord blood and lithium may treat some injuries very well and therefore it would be frustrating to hold it back while testing other treatments.

  7. #347
    time is our only enemy
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  8. #348
    Senior Member lunasicc42's Avatar
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    Quote Originally Posted by Christopher Paddon View Post
    Wise, would you consider, if all went well, having a therapy go into 'general' use, for example the cord blood and lithium treatment you are testing now, while carrying on testing other therapies?

    I think what I am thinking is that cord blood and lithium may treat some injuries very well and therefore it would be frustrating to hold it back while testing other treatments.

    I agree
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  9. #349
    Why not do several clinical trials during the same period?just because money?

  10. #350
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    Hello Wise, what is your opinion on schawn cells that Univerity of Miami is going to use for its clinical trials?

    Brent

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