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Thread: Why dr Wise avoid answer about Iran!

  1. #1

    Why dr Wise avoid answer about Iran!

    Dear dr Wise,

    I appreciate your work in stem cells researches. I want to know your opinion about treatment in Iran. I asked you two times about their treatment and about this attachment http://sci.rutgers.edu/forum/attachm...0&d=1170751830

    Do you avoid answering in this thread or maybe you have not seen it yet?
    I want to go there as fast as possible. I don't care about their nationality and location. I need the cure and some specialists opinions.

    Regards Michal
    Ab alio exspectes, alteri quod feceris.

  2. #2
    Banned adi chicago's Avatar
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    poor dr.young ....everyone of us is asking him....CURE ,WHERE ,WHEN,HOW MUCH ?he is a brilliant man and very patient and honest.
    i wish to be ab again like all the cc members and after that to meet everyone and to have fun and a dancing contest.i will do my best to win.
    • Dum spiro, spero.
      • Translation: "As long as I breathe, I hope."

  3. #3
    Senior Member CapnGimp's Avatar
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    This does NOT puport to be a CURE. It states that it is an APPROACH towards that end. THERE DOES NOT EXIST A CURE for sci at the present time.

  4. #4
    Banned adi chicago's Avatar
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    until a cure will save me from death...i will cure myself .....love and self determination .my cure advice for all of you .
    the body dies ...the soul and remembrace ....never.
    • Dum spiro, spero.
      • Translation: "As long as I breathe, I hope."

  5. #5
    Hi Oxygen. A cure for SCI does not exist. Anyone claiming to have a cure is misleading you and preying upon your desperation for financial gain.

  6. #6
    Quote Originally Posted by oxygen
    Dear dr Wise,

    I appreciate your work in stem cells researches. I want to know your opinion about treatment in Iran. I asked you two times about their treatment and about this attachment http://sci.rutgers.edu/forum/attachm...0&d=1170751830

    Do you avoid answering in this thread or maybe you have not seen it yet?
    I want to go there as fast as possible. I don't care about their nationality and location. I need the cure and some specialists opinions.

    Regards Michal
    Michal,

    I have expressed my opinion about the Iran group. If you do a search of this site, you will find several posts where I have indicated my skepticism about the animal study by Iran and my belief that there is not enough credible information about the human study to rush to Iran.

    Wise.
    Last edited by Wise Young; 02-18-2007 at 08:44 PM.

  7. #7
    Banned adi chicago's Avatar
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    i don`t want to die until a cure will help us again.
    i miss the grass ,my legs and toes too.
    i sleep every night having hope and ....never ever give up your dream...
    • Dum spiro, spero.
      • Translation: "As long as I breathe, I hope."

  8. #8
    Quote Originally Posted by adi chicago
    i don`t want to die until a cure will help us again.
    i miss the grass ,my legs and toes too.
    i sleep every night having hope and ....never ever give up your dream...
    Adi,

    I know what you mean. Perhaps it is time to focus on reality.

    There are two reasons for clinical trials. The first is to show that treatments are safe and effective. The second is to show that treatments are not safe or effective. One of the reasons why you and others are going through all of this right now is because we currently have no system of determining whether treatments are safe or effective.

    Hungyun Huang trained with me and I know how strongly he believes that his treatment works. Yes, as you know, it doesn't work for everybody. More important, I am not sure that the treatment is as effective as it should be and believe that it would be more effective if it were combined with other treatments.

    We strongly considered putting fetal OEG to test in our first clinical trial in ChinaSCINet. We decided against doing this for the following reasons:
    • It would have been very difficult to do a sham-surgery controlled clinical trial in China. We have to have a baseline cell transplant therapy against which to compare OEGs.
    • The fetal tissues are not HLA-antigen matched and thus should be rejected. Animal studies indicate that fetal OEG cells are not immune-privileged when transplanted into the brain or spinal cord.
    • There is a shortage of qualified fetal tissues for transplantation. We could not have gotten the cells for transplantation. Furthermore, we would have to put together a GMP-qualified cell processing facility.

    However, in the past year, several centers have gone ahead to repeat Dr. Huang's work. So, at the present, 4 centers have now transplanted between 10-60 patients with fetal OEG cells. Generally, I think that that results have been similar. Most of the patients are getting back some sensory function and a minority are getting significant motor function back. The return of function tends to be rapid (within weeks) and mostly sensory. Although the subjects retain the improvements that they experience during the weeks after implantation, function does not seem to continue to improve longer than several months.

    We decided to do cord blood mononuclear cells transplants ± lithium for the following reasons:
    • Cord blood is available in HLA-matched units, thus reducing immune rejection.
    • The safety record of cord blood cells is very good. Thousands of people have received cord blood transfusions in the past 20 years.
    • Several groups have reported that umbilical cord blood is beneficial for spinal cord injury and some clinics are transplanting the cells.

    So, our trial will determine whether umbilical cord blood mononuclear cells are safe and effective for improving function in people with chronic spinal cord injury. It will also determine whether lithium treatment for 6 weeks would improve the function more. At the present, we are doing a phase 1 lithium only trial, to establish safety and feasibility.

    The trial that we are planning has encountered several obstacles, including funding and regulatory hurdles. In order to do a clinical trial of about 400 subjects, it will cost us minimally US$20,000 per subject, as well as the cost of the processing the cells. China's clinical trial regulatory system is changing just as we are starting the network and they have imposed very strict regulations, including GCP-qualifications for all clinical trial centers and the necessity for China-based cell processing centers that meet GMP standards.

    Why, you may ask, do we want to study 400 subjects? At the present, we are not absolutely sure that we will need 400 but I am estimating that number based on the data that we have to date. To detect a 20% improvement in neurological function, we need to have at least 60 subjects per treatment group. To detect a 10% change, we need to have about 120 subjects. Generally, it is safe to "overpower" clinical trials because data may be more variable than one expects for a variety of reasons.

    There is another reason why I would like to have enough subjects for a definitive study. Doing it all at one time is much more efficient and gives us a credible answer within two years. If we do a number of small trials, it may take 4-8 years to get a credible answer. I don't know whether umbilical cord blood mononuclear cells are the best cells. If they are not, I want to know that as soon as possible. If they do have some therapeutic effect, they would the perfect control group against which to compare other therapies. All new experimental therapies should be compared against the best available therapy.

    We must choose who should be included in the clinical trial. Let's say that we are studying 400 subjects. Just having two treatment groups means that there will be 200 subjects per treatment. Now, if we decide to include ASIA A, B, and C, we would need to stratify the treatmen groups. Since there are relatively few B's, this really means that we will have about 100 subject with A or B/C per treatment group. Based on this alone, having a 400 subject trial with two treatments and including ASIA A, B, and C's will allow us to detect 10-20% improvement in neurological function due to the treatment.

    Many people are asking why we don't just do 12 or 24 patients. Doing 12-24 subjects will not tell us much except safety and feasibility. Because we would not have a control group, the data would not be credible to the world. The data would be very similar to what has been obtained for the alternating current trial, the Proneuron trial, or the Cethrin trial. Basically, these trials showed a ASIA A to C conversion rate of 25-30% between pre-treatment and post-treatment exams in groups of 12-24 patients.

    The problem with non-controlled trials is that nobody believes their results. The treatment that dribbles on for year and even decades without a definitive clinical trial to show that it works or does not work. What will happen is exactly what has happened to Hungyun Huang's fetal OEG treatment. It becomes controversial with people taking sides without much data to show that the treatment is effective or not effective.

    People write to me and ask what I think about the Iran claims of having a treatment that is making patients walk. I write back telling them that I really don't know. I look at their single animal study and don't find the results to be impressive. I read about the procedure they use and don't find that it is that different or better than others that I have seen and that are not yielding credible treatment effects. I am not impressed by the propaganda that they are putting out. Incidentally, I want to say that I know some superb good Iranian surgeons and that my skepticism concerning the work there is not because it is Iran.

    How can people decide? We need good and trustworthy information to base therapeutic decisions. If a treatment does not work, we need to know it so that people don't continue to waste their time, money, and bodies. If a treatment works, we need to know it so that we can work on improving it. That is what clinical trials are all about.

    Wise.
    Last edited by Wise Young; 02-19-2007 at 02:36 AM.

  9. #9
    Banned adi chicago's Avatar
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    thank you .dr.wise i will never give up hope ...say hello to others scientists and cure me please.[all sci from the world].i trust you.and i apreciate your hard work .good bless you.
    • Dum spiro, spero.
      • Translation: "As long as I breathe, I hope."

  10. #10
    Senior Member Robynbird569's Avatar
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    It is interesting reading your article Dr. Wise. It gives hope and faith for a cure more power. Darn that it has to take so long. I understand why tho. Keep up the good work!


    Stay safe my son. See you around thanksgiving!

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