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    I am pretty sure that the trials haven't started yet
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


    2010 SCINet Clinical Trial Support Squad Member
    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

    Comment


      Originally posted by lunasicc42 View Post
      I am pretty sure that the trials haven't started yet
      Correct. And even if they had, the results are still a year away.

      Originally posted by Wise Young
      We are assessing the patients at 6 weeks, 6 months, and a year.
      SOURCE

      Comment


        Originally posted by ChuckFoss View Post
        Dr. Young, thank you for explaining (once again) the details involved with the SCINetUSA clinical trials. Your patience and drive to help us understand and to get folks involved is extraordinary!
        This detailed explanation would be a great addition to the JustADollarPlease site. I think people are more apt to donate to a cause they can wrap their head around. The history and break-down of the trial phases was very informative. I know you've explained all this before, but having this amount of detail in one place on JustADollarPlease will help convince potentail donors who are on the fence.
        Thanks again.
        I was about to write something like this, but Chuck saved me the trouble. Thanks Chuck! Quite a few of the people who have bought bracelets or demonstrated interest in the trials find the SCINetUSA site a little confusing when I send them the link. Some sort of updated version would be great.

        Comment


          Originally posted by Wise Young View Post
          Spidergirl,

          You have highlighted that two major problems that face the spinal cord injury community and the main reasons why we have had no progress in clinical application of promising therapies shown in animal studies to humans.

          The first problem is the ridiculously low investment that our society and government is making towards the cure for spinal cord injury. The amount of funding is not clear but I estimate the amount to be somewhere in the range of $100 million per year. Spinal cord injury costs society about $20 billion per year. If you were British Petroleum and suffering a loss of $20 billion of leaking oil, would you spend just $100 million to solve the problem? Our society can easily afford to spend a billion dollars a year on spinal cord injury research. Much evidence indicates that it costs more than $1 billion to take a treatment from discovery to market. At our current rate of spending of $100 million per year on perhaps 10 different therapies, this means that it will take 100 years for a therapy to reach market. Does it seem too much to ask for government and society to spend $1 billion per year to cure spinal cord injury research. That is less than 5% of costs.

          The second problem is the loss of hope in the spinal cord injury community. In your words, the spinal cord injury community has "lost its way". Christopher Reeve believed in the eventuality of the cure. He also believed in setting goals. Many naysayers attacked his goals. It takes courage to set goals because you don't control everything and you cannot always achieve the goal. He understood that if you don't set goals, you don't achieve them. As you know, I disagree with you regarding biological cures. I believe that treatments that restore function will happen and it is a matter of finding the right combination and approach.

          What can we do about these two problems? The funding is matter of setting priorities. There is no question that our nation has the capability to fund the cure for spinal cord injury research. The federal government spent over a trillion dollar last year just stimulating the economy. The state of California alone is spending over $300 million per year on stem cell research, spending that by the way is showing enormous return for regenerative medicine. So, the reason why the government does not spend the money is not a lack of money but a lack of will.

          The lack of hope is a related and probably underlying reason for the lack of funding. Everybody that I talk to would like to see spinal cord injury cured. However, we are fighting centuries of prejudice, of naysayers, of doctors and scientists who have been trained to say no. This is of course not new. Most people with spinal cord injury don't believe that there will be a cure, at least during their lifetime. Some believe that there will never be a cure. I still remember the care and cure debates in the late 1990's. Many people with spinal cord injury actually opposed funding of research, saying that it is taking money away from cure. We have come a long ways from that time but still have not come far enough.

          The odd thing is that most doctors and scientists now believe that there will be a cure but many people in the spinal cord injury community do not. All the doctors who have joined and want to join the ChinaSCInet and SCINetUSA believe that there will be therapies of spinal cord injury and are very anxious to start testing these therapies in people. To my surprise, in the last few years, some members of the spinal cord injury community not only drew back from the hope but began attacking those who are expressing hope.

          There are many things in our body that we take for granted but are miracles. For example, the fact that you can smoke and your lung keeps repairing itself for years and years is a miracle. This is also true of alcoholics who repeatedly damage their liver, expecting the liver to repair itself over and over again. Although we did not know this until recently, our brains and spinal cords are constantly renewing themselves through stem cells. We take all this for granted except when it does not occur or we have exceeded the limits of the system to repair itself. Then, it becomes a veil of tears.

          We think, for example, that ALS (amyotrophic lateral sclerosis) is a terrible disease that happens to a few of us. Something is killing the motoneurons. I suspect that motoneurons are dying in all of us but, in people with ALS, the motoneurons are dying a little faster and the mechanisms for repairing and replacing them are not sufficient. That is why this is a disease that shows up in people in the late 30's. Lou Gehrig, for example, was one of the best athletes in the world for over 30 years before succumbing to the disease that bears his name.

          A lot of people believe that the spinal cord cannot recover from injury. But, anybody who has been in a rehabilitation center knows that there are many who do recover. I was talking to a very good friend who is mother to a friend with spinal cord injury. She mentioned seeing all these people coming to the hospitals with severe spinal cord injuries and just a patch of sensation and a little movement here and there. Six weeks later, they walk out of the hospital but her son remained. The difference between complete and incomplete spinal cord injury is less than people think. The goal of spinal cord injury treatments is of course to make people more incomplete. I believe that it is possible and the first therapies that will do so will be shown to work within the next few years. Finally, I know that if we don't try, we will never know.

          Finally, let me address the issue of having a videotape of walking animals. As some of you may have realized, I do not believe in showing such videos, even though they may have great public relations and fundraising effect. Why? Because such videos are ultimately misleading and anybody can show such videos. Animals are no different from humans in this regard. If they are incomplete, they will walk. All you have to do to create a walking animal is to hit their spinal cord slightly less hard. So, you have a rat scampering around. Does that mean that you have a cure? I can just as easily show a person with incomplete spinal cord injury walking out of a hospital. Does that mean that we have a cure?

          We need to do good science. Videotapes of walking animals is not always bad science but it can be abused. To prove that treatments are effective, we must do randomized controlled clinical trials with large numbers of patients. This is accepted for all other diseases and conditions. Why is this so hard to get accepted in spinal cord injury. Yes, I understand that seeing is believing, that a single walking animal may raise $25 million. That is probably how some scientists raised their money. I am not willing to do it. It is too easy to fake and is misleading.

          Wise.
          This post that I wrote to Spidergirl nearly a year ago clearly expresses the reasons why I am working so hard to start clinical trials for chronic spinal cord injury around the world. While I was in Norway recently, people asked me why I am setting up clinical trials in Norway? Let me try to answer that question here.

          Norway is one of the wealthiest countries in Europe (judged by the amount of money spent by the government per person). This was because Norway had the wisdom to require that revenues collected from oil in the North Sea be used to benefit the people of Norway. This is as opposed to other countries where much of oil revenues end up in the pockets of relatively few people. They have "cradle-to-grave" health care. While bureaucracy is slow to respond, it has one of the best health care systems in the world.

          Norway has three major spinal cord injury centers to serve perhaps 2500 people with chronic spinal cord injury. They recently built a stem cell center in Oslo that has the capability of preparing cells for transplantation. They of course have surgeons who can transplant the cells and rehabilitation doctors who are very interested in the effects of rehabilitation on recovery of function after regenerative therapies. In addition, they do high-quality science in Norway. Given this situation, Norway is a nearly ideal place to do clinical trials.

          Why not just do it in China? Although ChinaSCINet is leading the way with the trials, if umbilical cord blood mononuclear cells and lithium were to improve function, we still have to face the task of getting the therapy approved around the world outside of China. For that reason, we are trying to initiate simultaneous phase III trials in India, Europe, and the United States. If the treatment is effective, it can be approved and implemented more quickly around the world, so that we don't have people travelling all over the world to get the therapy.

          Finally, we need to do these trials for credibility. A major problem that we have been facing in the field of spinal cord injury is lack of credibility or perhaps lack of people who are willing to believe data that comes from China. Part of this is a "not-invented-here" syndrome where the clinical and scientific leadership of a country simply does not believe that clinical trials carried out elsewhere is as good as their own. Part of it is ignorance because many in Europe and the United States are assuming that the quality of clinical trials and science in China is not as good as their own. Also, nearly every country in the world have their own treatment approval agencies that require local clinical trials. We will be doing phase III clinical trials in the four major populations in the world: China (1.4 billion), India (1.3 billion), Europe (800 million), and United States (300 million).

          Wise.

          Comment


            Exclusion citeria

            Dear Dr wise

            Can you please tell us if candidates who have a spinal cage inserted into the vertebre, existing pressure sores and acute spinal stenosis are part of the exclusion criteria for the chinasci trials

            Comment


              Originally posted by peterf View Post
              Dear Dr wise

              Can you please tell us if candidates who have a spinal cage inserted into the vertebre, existing pressure sores and acute spinal stenosis are part of the exclusion criteria for the chinasci trials
              These are not part of the exclusion criteria but the investigators are charged with the responsibility of excluding any patients that they think may not be suitable for the risks of the surgery and clinical trial. The trial in Hong Kong requires that a reasonably clear MRI scan be obtained of the injury site and substantial effort is made to obtain a diffusion-tensor image of the injury site. The trial in Kunming will not require an MRI.

              I don't know whether MRI will be part of the requirement for the SCINetUSA trials. The presence of a cage may interfere with the MRI. This decision will be made by the investigators. We originally required an MRI before and after the procedure so that complications such as hemorrhage can be detected. However, hemorrhage can be detected with CT scans as well and if the surgeons are comfortable with just CT, the trial can go ahead without clear MRI's. This was the decision made by the doctors in Kunming.

              Regarding decubiti, this is also up to the surgeons. Of course, if the pressure sore is infected and the person has a fever or other signs of an infection, this would not be good and it is unlikely that the surgeon will accept a person with an infection. However, if the decubitus is small, uninfected, and healing, I don't think that this would necessarily prevent participation in the trial. This is up to the doctor.

              Regarding spinal stenosis, much depends on the nature and extent of the stenosis, whether the spinal cord is compressed. If the spinal cord is compressed, we will probably exclude the patient from the trial because we would not be able to tell whether the decompression or the cell transplants resulted in any recovery. The surgeon may choose to decompress the patient before the transplantation. These decisions have not yet been made.

              Wise.
              Last edited by Wise Young; 18 May 2011, 11:29 AM.

              Comment


                Tks Dr Wise for your very quick reply
                Just love to read your postings

                Your info about trial criteria, metal spinal cages and MRI was very interesting, now i know it's better to have a radiolucent cage inserted for MRI purposes

                Comment


                  Dr. Young or anyone.. Do we know if it makes a difference what grade the Titanium cage is? I was under the impresion it is easier to see through the different grades of metals. Thank you..

                  Comment


                    Originally posted by catlikekg View Post
                    Dr. Young or anyone.. Do we know if it makes a difference what grade the Titanium cage is? I was under the impresion it is easier to see through the different grades of metals. Thank you..
                    If there is iron in the cage, that interferes more with MRI. Pure titanium does not interfere but titanium is quite brittle and many manufacturers put in different elements to improve the flexibility of the metal. Often, it is impossible to tell until you actually put a patient into an MRI machine. We had one patient who had metal both in front and to the back of the injury site and we were able to visualize the spinal cord and obtain diffusion tensor images from the spinal cord. In China, most of the rods, screws, and other devices have steel in them and we often cannot even see the spinal cord because of the interference.

                    Wise.

                    Comment


                      I have read that PEEK or carbon fibre is now being used instead of titanium

                      Comment


                        Dr. Young if upon operation the operating Dr.s find some hardware may be better off extracted will they do so? Also will the Dr.s goals be to remove any bonefragments or stuborn scar tissue? Thank you

                        Comment


                          I have a good feeling about the very near future for us all. Dr. Young thank you

                          Comment


                            Originally posted by catlikekg View Post
                            Dr. Young if upon operation the operating Dr.s find some hardware may be better off extracted will they do so? Also will the Dr.s goals be to remove any bonefragments or stuborn scar tissue? Thank you
                            It will be up to the doctor. Our position is that no hardware should be removed just for the trial. If your doctor believes that removing the hardware would be beneficial to you, it can be removed before the trial.

                            Wise.

                            Comment


                              still on track for early 2012 start date? by my calculations, 2012 is right around the corner.

                              Comment


                                wise young, can you give us some update on this coming trial? you had said early 2012 and now ive read where you say "later in 2012". whats going on?

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