Thread: ChinaSCINet Update

  1. #1691
    Quote Originally Posted by #LHB# View Post
    Dr Young. Have you or have you ever thought off video taping the patient before treatment doing a wide range of exercises and then say at 6 month and 12 month follow up dates? Reason I ask is because even for a person with sci it would be easier to follow what the person has regained even though we already know what were looking at. It just seems to me that if you did so it would be ALOT easier to follow for the people you are trying to get donations from if they were not firmiliar with sci. Kinda painting an easier picture for them to follow. Thanks
    #LHB#,

    There are videotapes of the subjects walking. However, we don't have video of the subjects doing a "wide range of exercises at 6 months and 12 months". Let me try to change your frame of reference here. Please understand that the spinal cord injury community is not the primary target of the clinical trials. We do clinical trials for three reasons:
    1. To convince regulatory agencies that the therapy is safe and effective. In most countries of the world, therapies cannot be practiced unless they are approved by the appropriate regulatory agencies.
    2. To convince doctors that the therapy is safe and effective so that they are willing to apply the therapy to their patients. They will not do so unless the therapy is approved by appropriate regulatory agencies.
    3. To convince insurance agencies that the therapy is cost-effective. They will of course not pay unless the therapy has been approved by regulatory agencies and both doctors and patients want to have the the therapy.


    I am personally not in favor of hyping a therapy at phase II levels. Once we have phase III evidence that the treatment is effective, that is the time when we must mobilize to get the therapy accepted. I have done many clinical trials and while the current results are very promising, we need to confirm them in rigorous phase III trials before I am willing to say that the treatment really works.

    As a member of the spinal cord injury community, it is important that you support the trials but not jump overboard. The trial results need confirmation. After all, we have disparate results from two trials, one in Hong Kong and one in Kunming. The former suggests that MR/DTI images of fibers growing across the injury site in in 2 of 5 subjects at 1.0-1.5 years after treatment. The latter suggests that 75% of subjects can recover minimally assisted walking at 6-12 months after injury but without corresponding improvements in motor and sensory scores.

    Yes, I am excited and optimistic about the prospects of umbilical cord blood mononuclear cells (UCBMC) therapy but I am only human and have many friends that I would love to see walk. I spend a lot of time thinking about this but the driving force in my mind is that we need to make sure that this is true. For 30 years, I have been conducting clinical trials. The results are often unexpected. In 1989, I was surprised by the results of NASCIS II showing that methylprednisolone improves recovery by 20% over controls.

    It is awful, isn't it, that neurosurgeons recently decided that they will not recommend high-dose methylprednisolone (MP) for acute spinal cord injury, because they are afraid of lawsuits, even though they don't have any data to contradict that rigorous clinical trials that showed that MP is effective in acute spinal cord injury. The fight to show that therapies are effective is not just about winning the hearts and minds of people with spinal cord injury but the approval of regulatory agencies, doctors, and insurance agencies that control medical care.

    We need to get the first therapy of chronic spinal cord injury established in the minds of the regulatory agencies, doctors, and insurance agencies. This paves the way for all others to follow.

    Wise.
    Last edited by Wise Young; 04-29-2013 at 08:36 AM.

  2. #1692
    Senior Member
    Join Date
    Jun 2011
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    North Carolina
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    853
    Quote Originally Posted by Wise Young View Post
    #LHB#,



    There are videotapes of the subjects walking. However, we don't have video of the subjects doing a "wide range of exercises at 6 months and 12 months". Let me try to change your frame of reference here. Please understand that the spinal cord injury community is not the primary target of the clinical trials. We do clinical trials for three reasons:
    1. To convince regulatory agencies that the therapy is safe and effective. In most countries of the world, therapies cannot be practiced unless they are approved by the appropriate regulatory agencies.
    2. To convince doctors that the therapy is safe and effective so that they are willing to apply the therapy to their patients. They will not do so unless the therapy is approved by appropriate regulatory agencies.
    3. To convince insurance agencies that the therapy is cost-effective. They will of course not pay unless the therapy has been approved by regulatory agencies and both doctors and patients want to have the the therapy.
    I am personally not in favor of hyping a therapy at phase II levels. Once we have phase III evidence that the treatment is effective, that is the time when we must mobilize to get the therapy accepted. I have done many clinical trials and while the current results are very promising, we need to confirm them in rigorous phase III trials before I am willing to say that the treatment really works.

    As a member of the spinal cord injury community, it is important that you support the trials but not jump overboard. The trial results need confirmation. After all, we have disparate results from two trials, one in Hong Kong and one in Kunming. The former suggests that MR/DTI images of fibers growing across the injury site in in 2 of 5 subjects at 1.0-1.5 years after treatment. The latter suggests that 75% of subjects can recover minimally assisted walking at 6-12 months after injury but without corresponding improvements in motor and sensory scores.

    Yes, I am excited and optimistic about the prospects of umbilical cord blood mononuclear cells (UCBMC) therapy but I am only human and have many friends that I would love to see walk. I spend a lot of time thinking about this but the driving force in my mind is that we need to make sure that this is true. For 30 years, I have been conducting clinical trials. The results are often unexpected. In 1989, I was surprised by the results of NASCIS II showing that methylprednisolone improves recovery by 20% over controls.

    It is awful, isn't it, that neurosurgeons recently decided that they will not recommend high-dose methylprednisolone (MP) for acute spinal cord injury, because they are afraid of lawsuits, even though they don't have any data to contradict that rigorous clinical trials that showed that MP is effective in acute spinal cord injury. The fight to show that therapies are effective is not just about winning the hearts and minds of people with spinal cord injury but the approval of regulatory agencies, doctors, and insurance agencies that control medical care.

    We need to get the first therapy of chronic spinal cord injury established in the minds of the regulatory agencies, doctors, and insurance agencies. This paves the way for all others to follow.

    Wise.
    Thank you for the responce. It is sad that they stoped giving MP to acutes. Then again if it was there son or daughter they would change there tune. I really didn't mean video the patients to overhype the trial when you dont know the final result yeat. I didn't explane myself very well. More like the sad HSUS videos you see on tv. It makes alot of people donate alot of money. Thats more what I was going for, the donation side of it. Seem's to me people like to see and visualize the diffrence there donation would make in someones life. Just a thought.

  3. #1693
    Doctor, have you noticed a difference in recovery between the different groups of cell dosage size? In other words, would it be safe to say yet that the 6.4 million cell dosage is more beneficial than 1.6 million? Or maybe it can even be answered this way, Of the couple patients that were able to walk better than KLS IV, could this be attributed to the high cell dosage?
    Will we have to wait for the published papers to understand if any patients have any bowel,bladder and or sexual function recovery?

  4. #1694
    Quote Originally Posted by Wise Young View Post
    #LHB#,

    There are videotapes of the subjects walking. However, we don't have video of the subjects doing a "wide range of exercises at 6 months and 12 months". Let me try to change your frame of reference here. Please understand that the spinal cord injury community is not the primary target of the clinical trials. We do clinical trials for three reasons:
    1. To convince regulatory agencies that the therapy is safe and effective. In most countries of the world, therapies cannot be practiced unless they are approved by the appropriate regulatory agencies.
    2. To convince doctors that the therapy is safe and effective so that they are willing to apply the therapy to their patients. They will not do so unless the therapy is approved by appropriate regulatory agencies.
    3. To convince insurance agencies that the therapy is cost-effective. They will of course not pay unless the therapy has been approved by regulatory agencies and both doctors and patients want to have the the therapy.


    I am personally not in favor of hyping a therapy at phase II levels. Once we have phase III evidence that the treatment is effective, that is the time when we must mobilize to get the therapy accepted. I have done many clinical trials and while the current results are very promising, we need to confirm them in rigorous phase III trials before I am willing to say that the treatment really works.

    As a member of the spinal cord injury community, it is important that you support the trials but not jump overboard. The trial results need confirmation. After all, we have disparate results from two trials, one in Hong Kong and one in Kunming. The former suggests that MR/DTI images of fibers growing across the injury site in in 2 of 5 subjects at 1.0-1.5 years after treatment. The latter suggests that 75% of subjects can recover minimally assisted walking at 6-12 months after injury but without corresponding improvements in motor and sensory scores.

    Yes, I am excited and optimistic about the prospects of umbilical cord blood mononuclear cells (UCBMC) therapy but I am only human and have many friends that I would love to see walk. I spend a lot of time thinking about this but the driving force in my mind is that we need to make sure that this is true. For 30 years, I have been conducting clinical trials. The results are often unexpected. In 1989, I was surprised by the results of NASCIS II showing that methylprednisolone improves recovery by 20% over controls.

    It is awful, isn't it, that neurosurgeons recently decided that they will not recommend high-dose methylprednisolone (MP) for acute spinal cord injury, because they are afraid of lawsuits, even though they don't have any data to contradict that rigorous clinical trials that showed that MP is effective in acute spinal cord injury. The fight to show that therapies are effective is not just about winning the hearts and minds of people with spinal cord injury but the approval of regulatory agencies, doctors, and insurance agencies that control medical care.

    We need to get the first therapy of chronic spinal cord injury established in the minds of the regulatory agencies, doctors, and insurance agencies. This paves the way for all others to follow.

    Wise.
    I bet regardless of the trial results they will fight tooth and nail to deny that it works. For some reason that seems to be the way..

  5. #1695
    Quote Originally Posted by Wise Young View Post
    Havok,

    In China, our current costs for doing clinical trials is about US$20,000 per subject, compared to US$100,000 in the U.S. The Chinese government now commits about 3.5% of their GDP to academic education and research. They recently announced that they are increasing it to 4.0% of their GDP and committing this it to translational research, including clinical trials. While ChinaSCINet has not directly received funding from the Chinese government, many of our participating centers have received grants from the Chinese government for clinical trials, allowing us to proceed with our work. We have been teaching many of the centers in China to do spinal cord injury research and clinical trials and helping them with their applications for grants. Things are highly competitive in China, as you can imagine.

    Wise.
    Thank you for the reply. Its really great to see the government is putting money into medical research, and as you said its even cheaper to conduct trials there. I truely believe China is on its way to leading the world in scientific discovery and the US is continuing to shoot itself in the foot. Well hopefully success with the current trial will warrent attention from the Chinese government for funding. Good luck and thank you for all your work.
    T6 complete since 3/21/2012

  6. #1696
    Quote Originally Posted by Wise Young View Post

    We need to get the first therapy of chronic spinal cord injury established in the minds of the regulatory agencies, doctors, and insurance agencies. This paves the way for all others to follow.

    Wise.
    This is exactly the thing I said from day 1 of my injury.....Thank you Wise for your courage and your effort

  7. #1697
    Dr. wise young, I am not in china, I live in the Uk and was hoping to join the trials in USA, would this be possible. Kim

  8. #1698
    Quote Originally Posted by Barrington314mx View Post
    Doctor, have you noticed a difference in recovery between the different groups of cell dosage size? In other words, would it be safe to say yet that the 6.4 million cell dosage is more beneficial than 1.6 million? Or maybe it can even be answered this way, Of the couple patients that were able to walk better than KLS IV, could this be attributed to the high cell dosage?
    Will we have to wait for the published papers to understand if any patients have any bowel,bladder and or sexual function recovery?
    Barrington314mx,

    So far, a strong pattern has not emerged. As you can imagine, with 75% of the subjects achieving KLS IV, we can't have a strong pattern. We also don't have the data from the last group (i.e. the highest dose of cells, methylprednisolone, and lithium) because these subjects were done last May. That is one of the reasons why I am so anxious to get all the data before saying anything.

    Regarding sexual, bowel, and bladder function, we did not do formal testing although we do have questionaires about some of these function (SCIM). We are planning more formal testing of such functions in the phase III trial.

    Wise.

  9. #1699
    Quote Originally Posted by Eric.S View Post
    I bet regardless of the trial results they will fight tooth and nail to deny that it works. For some reason that seems to be the way..
    Eric, I hear you. The first time is always the most difficult but, so far, many doctors around the world are enthusiastic about participating in the trials. So, perhaps this will be different. Wise.

  10. #1700

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