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Thread: ChinaSCINet Update

  1. #1001
    Senior Member
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    Wise will you be starting phase3 trials in India or phase2? Are u thinking to include lower lumbar injuries in india trial or not yet?

    Can foreign patients join trials in india or norway?

    Researchers at Silk Institute have produced neurons from Umbilical cells recently. Hope you read at carecure. If so umbilical cells can be tested in lower injuries too.

  2. #1002
    Jawaid theres no stemcell trials in Norway for all I know. One year ago I damaged my spinal cord and was at the biggest rehab centre for sci patients in scandinavia here in Norway. No one talked about coming stem cells trials, although my neighbour patient got injected with stem cells at stem cells inc and participated in their trials.

  3. #1003
    Junior Member
    Join Date
    Mar 2011
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    Hi Dr Young
    Is it possible to get a list of the exercises regime that was done in the china trial. I would like to do at home. I already do quite a bit of pt at home including treadmill, recumbent bike, leg press, leg raises etc. I walk now full time with crutches and progress has been continuous but slow. I'd like to see if there is more I can be doing to speed my recovery.

    Thanks

    James

  4. #1004
    Quote Originally Posted by Wise Young View Post
    My specific comments are embedded and my general comments follow.

    Originally Posted by paolocipolla
    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.
    Good


    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.
    A non profit org could sposnsor the non resident patients, like "just a dollar please" for example


    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.

    So it seems we agree that in a trial for chronic SCI likely you need fewer patients per arm than in an acute 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.
    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.
    Good, so let's work out some solutions here for a quicker trial next time.

    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.
    You are talking about acute SCI here. May I suggest you not to mix acute trials with chronic trials? They are two very different "business" & people get esily confused especially if you mention walking.. unless that would be the goal

    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.
    If you can get few people out of w/c I think it's easy, or at least if you show me the data and the people I will believe you.

    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.

    But investors wants to make money, so once they invest money in a therapy they will try to push it to the market even if there is something better getting ready.


    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.
    See in blue my comments.

    Paolo
    In God we trust; all others bring data. - Edwards Deming

  5. #1005
    Quote Originally Posted by Imight View Post
    So the person you had in the bw photo, is acute? I thought most of your patients were chronic. I also thought they were walking unassisted. It sounds like you've already taken note that they DO need stem cell therapy AND her training to walk again. She's clearly not accomplishing the results without the injection.

    I guess I'm just doing this for endurance at this point. That hurts.
    Wise,

    here above is an example of how people can get confused hearing/reading what you say.
    You can always say that people misunderstand, but that is not how the "communication process" works.

    Paolo
    In God we trust; all others bring data. - Edwards Deming

  6. #1006
    Quote Originally Posted by KofQ View Post
    Who are currently performing these functions?
    I have a staff of 4 people in Hong Kong. They are supported by the Hong Kong Spinal Cord Injury Fund. They do all the regulatory work, clinical trial monitoring, planning, and fundraising for ChinaSCINet. I fly there every 3 weeks.

    Wise.

  7. #1007
    Quote Originally Posted by paolocipolla View Post
    Wise,

    here above is an example of how people can get confused hearing/reading what you say.
    You can always say that people misunderstand, but that is not how the "communication process" works.

    Paolo
    Paolo,

    Are you dissatisfied with my communication skills or suggesting that I am misleading people? There is a difference.

    Regarding your comments in blue, may I suggest that you raise some funds for clinical trials in Italy before you criticize how ChinaSCINet has been conducted. If there is anything that you don't understand, I would be more than glad to answer your questions as best as I can but I cannot take any of your comments seriously until you show that you understand what it takes to raise the funds for and to do clinical trials. By the way, if you think that I am being unfair to you by asking you to do this, please look what Christopher Reeve did from 1996-2004. He raised over $100 million for spinal cord injury research during this period. Christopher was not so different from you. In fact, he was actually much worse off than you because he was much more severely injured and had no means of supporting his care and family.

    Wise.
    Last edited by Wise Young; 07-21-2012 at 07:00 PM.

  8. #1008
    Quote Originally Posted by Jawaid View Post
    Wise will you be starting phase3 trials in India or phase2? Are u thinking to include lower lumbar injuries in india trial or not yet?

    Can foreign patients join trials in india or norway?

    Researchers at Silk Institute have produced neurons from Umbilical cells recently. Hope you read at carecure. If so umbilical cells can be tested in lower injuries too.
    The trials are being planned for mid-2013. Much depends on our success in getting agreements with the participating organizations and also fundraising. I was in India in June and will be in India again in September.

    Wise.

  9. #1009
    Quote Originally Posted by dorsal fin View Post
    Jawaid theres no stemcell trials in Norway for all I know. One year ago I damaged my spinal cord and was at the biggest rehab centre for sci patients in scandinavia here in Norway. No one talked about coming stem cells trials, although my neighbour patient got injected with stem cells at stem cells inc and participated in their trials.
    dorsal fin, I am hoping to get trials started in Norway in 2013. There are none currently going on. Wise.

  10. #1010
    Quote Originally Posted by Oocofficial View Post
    Hi Dr Young
    Is it possible to get a list of the exercises regime that was done in the china trial. I would like to do at home. I already do quite a bit of pt at home including treadmill, recumbent bike, leg press, leg raises etc. I walk now full time with crutches and progress has been continuous but slow. I'd like to see if there is more I can be doing to speed my recovery.

    Thanks

    James
    James,

    The exercise is simple. It is just walking with a rolling support cart for 6 hours a day 6 days a week. They start by standing and progress to stepping with somebody walking behind with ropes to lock the knees during stance phase. Eventually, the person is able to lick their knees by themselves. At some point, the person can use a four point walker, then crutches, and then crane.

    They do have exercises for the hands and arms but I don't think that these are as systematic. Every morning, all the patients go through about an hours of calisthenics, with music and a nurse standing in front of all the patients leading the calisthenics.

    Dr. Zhu has now moved from the Kunming Army General Hospital to a separate private hospital in Kunming where she will be much better staffed and equipped. In addition, she will be able to take foreign patients for the first time. She just moved and does not yet have the staff to handle a large volume of enquiries. I will post as soon as I know that she is ready to do so.

    Wise.

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