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Thread: For Dr Young

  1. #1
    Senior Member soonerborn's Avatar
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    For Dr Young

    From what I have seen on this web site and the research that has come out of China on stem cells when would be a good time to get the injection of stem cells done? I am also wondering what I need to do to be able to go next summer to have this procedure done?
    I have a few more questions if I would be a good candidate for it, but my stats are T8 complete, bruising of the spinal cord, 28yrs old, little over 2 years post, I do use a standing frame and I am very active.
    I am saving my money and will get a loan to try this procedure. I believe it can and will work. I would be happy with bladder and bowel function to return.
    Thanks in advance for taking your time, your doing great things with stem cells!

  2. #2
    Did you have time to look at this?

  3. #3
    at my work, we r having a peer conference in SEPT 09, one of the guest speakers had gone to china and did stem cell injections. i can ask him if you can contact him...
    "Always look at the bright side of life...."

  4. #4
    Quote Originally Posted by soonerborn View Post
    From what I have seen on this web site and the research that has come out of China on stem cells when would be a good time to get the injection of stem cells done? I am also wondering what I need to do to be able to go next summer to have this procedure done?
    I have a few more questions if I would be a good candidate for it, but my stats are T8 complete, bruising of the spinal cord, 28yrs old, little over 2 years post, I do use a standing frame and I am very active.
    I am saving my money and will get a loan to try this procedure. I believe it can and will work. I would be happy with bladder and bowel function to return.
    Thanks in advance for taking your time, your doing great things with stem cells!
    soonerborn, I would strongly recommend against paying for any of the cell transplant procedures in China being offered at the present. To my knowledge, none have been adequately shown in clinical trials to be effective to warrant payment for the procedures. While we are continuing to push as hard as we can to go ahead with clinical trials of umbilical cord blood cells and lithium trials in China, several recent development have been quite discouraging.

    On May 1, 2009, the Mininistry of Health of China issued new regulations that would take place in November 2009. These new regulations require all hospitals that provide cell transplantation treatments to be accredited and all cell transplant procedures to be approved. We were in the process of getting a clinical trial approved at the Kunming Army General Hospital and had all but obtained permission and a grant to do so when this ruling came out that we were told that we need approval from the Ministry of Health.

    We have now met senior officials of the Ministry of Health. One department head told us that our trial was not the responsibiity of his department and referred us to another. That department in turn said that it wasn't their responsibility and referred us to the sFDA (the state Food and Drug Administration). We wrote to the sFDA and just received a reply saying that this was the jurisdiction of the Ministry of Health. In short, nobody is making any decisions or taking responsibility for approving clinical trials involving cell transplants. I suspect that it may be many months before this bureaucratic issue is resolved. We have been trying to get permission to do the trial since last year.

    In my opinion, the situation is worse for people who are currently doing cell transplants. Centers, such as the Xishan Center of Hongyun Huang and the Beike Biotechnology Centers that are transplanting umbilical cord blood cells into patients with spinal cord injury, will not be permitted to continue beyond November 2009. The approval process is complicated. The Ministry of Health has identified ten organizations that have been given the responsibility of reviewing and approving the institutions and clinical practices. My staff called several of these organizations and they said that they don't know exactly how it is going.

    China did this once before with organ transplants two years ago. They announced the regulations and then required all hospitals to be certified before they can do the procedures and all the procedureds to be approved. In terms of cell transplants, the standards and efficacy criteria are much less well-established than organ transplants. I suspect that most of the procedures that are experimental will be stopped in China.

    Wise.

    Wise.

  5. #5
    Quote Originally Posted by Wise Young View Post

    On May 1, 2009, the Mininistry of Health of China issued new regulations that would take place in November 2009. These new regulations require all hospitals that provide cell transplantation treatments to be accredited and all cell transplant procedures to be approved. We were in the process of getting a clinical trial approved at the Kunming Army General Hospital and had all but obtained permission and a grant to do so when this ruling came out that we were told that we need approval from the Ministry of Health.


    Wise.
    Is that going to affect in some way the SCINetUSA?

  6. #6

    well said

    Quote Originally Posted by Wise Young View Post
    soonerborn, I would strongly recommend against paying for any of the cell transplant procedures in China being offered at the present. To my knowledge, none have been adequately shown in clinical trials to be effective to warrant payment for the procedures. While we are continuing to push as hard as we can to go ahead with clinical trials of umbilical cord blood cells and lithium trials in China, several recent development have been quite discouraging.

    On May 1, 2009, the Mininistry of Health of China issued new regulations that would take place in November 2009. These new regulations require all hospitals that provide cell transplantation treatments to be accredited and all cell transplant procedures to be approved. We were in the process of getting a clinical trial approved at the Kunming Army General Hospital and had all but obtained permission and a grant to do so when this ruling came out that we were told that we need approval from the Ministry of Health.

    We have now met senior officials of the Ministry of Health. One department head told us that our trial was not the responsibiity of his department and referred us to another. That department in turn said that it wasn't their responsibility and referred us to the sFDA (the state Food and Drug Administration). We wrote to the sFDA and just received a reply saying that this was the jurisdiction of the Ministry of Health. In short, nobody is making any decisions or taking responsibility for approving clinical trials involving cell transplants. I suspect that it may be many months before this bureaucratic issue is resolved. We have been trying to get permission to do the trial since last year.

    In my opinion, the situation is worse for people who are currently doing cell transplants. Centers, such as the Xishan Center of Hongyun Huang and the Beike Biotechnology Centers that are transplanting umbilical cord blood cells into patients with spinal cord injury, will not be permitted to continue beyond November 2009. The approval process is complicated. The Ministry of Health has identified ten organizations that have been given the responsibility of reviewing and approving the institutions and clinical practices. My staff called several of these organizations and they said that they don't know exactly how it is going.

    China did this once before with organ transplants two years ago. They announced the regulations and then required all hospitals to be certified before they can do the procedures and all the procedureds to be approved. In terms of cell transplants, the standards and efficacy criteria are much less well-established than organ transplants. I suspect that most of the procedures that are experimental will be stopped in China.

    Wise.

    Wise.

    I totally agree with Wise... I've read about 20 - 30 articles and spoke to some people that went to China/India. It's a waste of money & time.

    u know, life it not totally bad being in a chair... it's how u view it and what u do with what you have that matters.
    "Always look at the bright side of life...."

  7. #7
    Quote Originally Posted by ChinaDoll View Post
    I totally agree with Wise... I've read about 20 - 30 articles and spoke to some people that went to China/India. It's a waste of money & time.

    u know, life it not totally bad being in a chair... it's how u view it and what u do with what you have that matters.
    ChinaDoll,

    While I believe that now is not the right time to go get stem cell therapies in China, for some people, life in a chair is not only intolerable but necessary for life.

    Treatments that restore function are critical for survival for poor people. In China and India, particularly, people die because they don't have access to care that we take for granted. For example, many people with spinal cord injury in China don't have access to intermittent catheterization and must rely on foley catheters. As you know, this results in repeated urinary tract infections that is deadly. Most cannot afford high-tech wheelchairs or the cushions that are necessary to prevent decubiti when sitting in these chairs. Also, most places are not accessible and so the people are often trapped inside their homes. So, many stay in bed and die. In India, I have heard doctors tell patients that they have to walk or die.

    It is one of the reasons why I continue to push for clinical trials in China, not just because it is cheaper to do the trials there but because Chinese need the treatments. There are more people with spinal cord injury in China than any other country in the world. I estimate that as many as a third of the world's population of spinal cord injury are in China, i.e. about a million people. For many of them, the cure is life-saving.

    Wise.

  8. #8
    Thanks Dr. Young. I guess I do take life for granted since I live in Canada. I understand what you mean thinking back to 11 years ago (last time i was in China). The general population's view on people with disabilities are: fear, avoiding the issue, ignorance and plainly don't know or sometimes care. not much awareness. I think for that reason, my parents refuse to let my relatives know of my situation, fearing they will think the worst of me.

    what can we do to create awareness in that community? how can i help?
    "Always look at the bright side of life...."

  9. #9
    Quote Originally Posted by ChinaDoll View Post
    Thanks Dr. Young. I guess I do take life for granted since I live in Canada. I understand what you mean thinking back to 11 years ago (last time i was in China). The general population's view on people with disabilities are: fear, avoiding the issue, ignorance and plainly don't know or sometimes care. not much awareness. I think for that reason, my parents refuse to let my relatives know of my situation, fearing they will think the worst of me.

    what can we do to create awareness in that community? how can i help?
    Awareness does not equal action or funding. When Christopher Reeve was alive, he brought much attention to cure of spinal cord injury. Many people were aware that spinal cord injury is curable and yet gave remarkably little private donations to spinal cord injury.

    In my opinion, we need to establish a group of people who are committed to curing spinal cord injury the right way, i.e. through clinical trials that prove that the therapies are safe and effective. Clinical trials are necessary to convince many doctors to apply the therapy to people. Clinical trial networks is the most efficient way of doing this.

    One way that you can help is to get your friends in the spinal cord injury community to work together and start funding clinical trials. I know many people who have spent many thousands of dollars on unproven therapies in overseas clinics that have no interest or ability to show that the therapy is effective.

    Clinical trials are not only essential for proving that therapies are effective and safe, hence allowing governments to approve them and insurance companies to pay for them, they are necessary to convince other doctors to use the therapies. Successful clinical trials attract investors and companies who will develop more and better therapies.

    When the clinical trials show the first successful therapies for spinal cord injury, the publicity will come automatically and everybody will want to invest in success.

    Wise.

  10. #10
    Senior Member soonerborn's Avatar
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    Dr. Young thank you for the response. Should I just wait for something else to come along? Is there another program that you would recommend another program? I really need something with a chance of walking to look forward to! Sorry to bother you with this. Thanks again for your work and answers.

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