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Thread: Clinical Trials

  1. #91
    Senior Member spidergirl's Avatar
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    Quote Originally Posted by Buck_Nastier
    Is this what you're talking about?
    Yes. The segment was much bigger. Actually I have never even heard of Dr. Snyder at all with all the research I have done and they say he is at the forefront of regenerative therapies when he puts UBC down?!?!? Really? Was he at W2W? I am glad you wished him the best but please Tijuana? I don't even trust a taco or some water there let alone OMG A STEM CELL PROCEDURE. I wish someone was smart enough around him to show him some light.

    http://sci.rutgers.edu/forum/showthread.php?t=82474
    Last edited by spidergirl; 05-25-2007 at 02:01 AM.

  2. #92
    Quote Originally Posted by spidergirl
    Yes. The segment was much bigger. Actually I have never even heard of Dr. Snyder at all with all the research I have done and they say he is at the forefront of regenerative therapies when he puts UBC down?!?!? Really? Was he at W2W? I am glad you wished him the best but please Tijuana? I don't even trust a taco or some water there let alone OMG A STEM CELL PROCEDURE. I wish someone was smart enough around him to show him some light.

    http://sci.rutgers.edu/forum/showthread.php?t=82474
    I said I thought it was a bad idea. I just hope it doesn't hurt him worse.

  3. #93
    Quote Originally Posted by spidergirl
    This is very interesting that you wrote this. In fact I was watching something on ABC on the news TODAY about some Iraqi War Veteran idiot going to Tijuana for an UBC blood stem cell procedure. He lived in San Diego which is just a hop, skip jump and away from Tijuana but still I was baffled that he would he even do this. I call him an idiot because Tijuana, Mexico is the last place I would go. I wouldn't even buy a pinnate there. The coverage was somewhat nice at least but than they had this other US Dr. Dr. Snyder come in and say that UBC stem cells will NEVER EVER cure spinal cord injury and they are not the right cells. He called them blood cells. Now I don't know if Dr. Young knows or you know who he is but this man straight put down everything the CHINASCINET stands for down. I was really in a state of shock. I am really exhausted right now to filter thru the internet and find the segment. It was on ABC at 6:00 PM in Los Angeles. (maybe someone else can post it if they can find it on utube ) This all just really coincides with a lot and leaves me scratching my head.

    Not to mention whoever this Dr. Snyder is said we are still decades away. I don't know where they found this guy to say anything. They found him under a rock. I mean they make regenerative therapies look like they are going to surface when cars are flying.
    Cheryl, please hang on. Evan Snyder is a good friend and if I had 10 minutes to present some of the data to him, I think that he would agree that cord blood is very interesting. Please understand that we are not using cord blood necessarily as stem cells. The spinal cord does not have the factors that is necessary to get cord blood stem cells or mesenchymal stem cells (from bone marrow or Wharton's jelly of umbilical cord) to produce neurons, astrocytes, or oligodendroglia. If that is what one wants to do, i.e. replace neurons and to have astrocytes, the cells have to be grown and differentiated in culture to become astrocytes, oligodendroglia, or neurons before transplanation. In fact, one has to do that with human embryonic stem cells as well and we have been discussing trying these cells.

    In any case, we are using cord blood mononuclear cells because we have found that these cells produce large amounts of neurotrophins when they are stimulated by lithium. We also find that axons don't mind growing on these cells and they do not provoke a wall of astrocytes around them when they are transplanted into the spinal cord. So, from that perspective, they are almost a perfect bridge cell. They migrate only short distances, are hospitable to growing cells, and respond to lithium by pouring the right kinds of neurotrophins. We want to see if they restore function in people with chronic spinal cord injury. That's it.

    That is why the phase 3 trial is designed so that everybody gets the cord blood mononuclear cell transplants and then people will be randomized to lithium or no lithium. The trial has several possible outcomes:
    • Cord blood mononuclear cell transplants alone are effective. That is a possibility since several animal studies suggest that it is so.
    • Cord blood mononuclear cell transplants alone are ineffective. This is also a possibility and because we are transplanting the cells directly into the spinal cord and they are HLA-matched, there will be no questions that the cells are there.
    • Cord blood mononuclear cell transplants plus lithium is associated with more recovery than cord blood cells alone. This would of course support our hypothesis that lithium-stimulated neurotrophin release results in recovery. If this recovery occurs slowly over a year or two, it would strongly suggest regeneration.


    Note that we are giving the lithium for only 6 weeks. We have no idea whether this is enough, too long or too short. On the other hand, if the transplanted cells survive, we should be always able to give the patients more lithium to see what happens. Note also that we only have two components of the combination therapy, i.e. the bridge and the growth factors. We need the third component, which is the axon growth inhibitor blockers (Nogo antibodies, Nogo receptor blockers, cethrin, chondroitinase, etc.).

    We are currently doing the lithium phase 1, i.e. giving patients with chronic spinal cord injury a 6-week course of lithium. We will then do a lithium phase 2, where we will randomize the patients to lithium or placebo and see if it improves neurological funciton. We will also carry out a phase 2 cord blood cell transplant trial. And then we will do the phase 3.

    Wise.



    may show that umbilical cord blood cells alone are effective. This is a possibility since several animal studies suggest that this is so. It may show that the cells don't do anything on their own. It is possib

    Wise.

  4. #94
    Senior Member spidergirl's Avatar
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    Quote Originally Posted by Buck_Nastier
    I said I thought it was a bad idea. I just hope it doesn't hurt him worse.
    \

    Yeah. I wonder how much dineros he paid for NOTHING. Like the big NOTHING from the movie The Neverending Story.

    We still are several years away there is no denying that. I just can't think about it anymore, it's so brainwracking that you have one life and one body and we become the exception to every rule.

  5. #95
    Senior Member spidergirl's Avatar
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    Quote Originally Posted by Wise Young
    Cheryl, please hang on. Evan Snyder is a good friend and if I had 10 minutes to present some of the data to him, I think that he would agree that cord blood is very interesting. Please understand that we are not using cord blood necessarily as stem cells. The spinal cord does not have the factors that is necessary to get cord blood stem cells or mesenchymal stem cells (from bone marrow or Wharton's jelly of umbilical cord) to produce neurons, astrocytes, or oligodendroglia. If that is what one wants to do, i.e. replace neurons and to have astrocytes, the cells have to be grown and differentiated in culture to become astrocytes, oligodendroglia, or neurons before transplanation. In fact, one has to do that with human embryonic stem cells as well and we have been discussing trying these cells.

    In any case, we are using cord blood mononuclear cells because we have found that these cells produce large amounts of neurotrophins when they are stimulated by lithium. We also find that axons don't mind growing on these cells and they do not provoke a wall of astrocytes around them when they are transplanted into the spinal cord. So, from that perspective, they are almost a perfect bridge cell. They migrate only short distances, are hospitable to growing cells, and respond to lithium by pouring the right kinds of neurotrophins. We want to see if they restore function in people with chronic spinal cord injury. That's it.

    That is why the phase 3 trial is designed so that everybody gets the cord blood mononuclear cell transplants and then people will be randomized to lithium or no lithium. The trial has several possible outcomes:
    • Cord blood mononuclear cell transplants alone are effective. That is a possibility since several animal studies suggest that it is so.
    • Cord blood mononuclear cell transplants alone are ineffective. This is also a possibility and because we are transplanting the cells directly into the spinal cord and they are HLA-matched, there will be no questions that the cells are there.
    • Cord blood mononuclear cell transplants plus lithium is associated with more recovery than cord blood cells alone. This would of course support our hypothesis that lithium-stimulated neurotrophin release results in recovery. If this recovery occurs slowly over a year or two, it would strongly suggest regeneration.

    Note that we are giving the lithium for only 6 weeks. We have no idea whether this is enough, too long or too short. On the other hand, if the transplanted cells survive, we should be always able to give the patients more lithium to see what happens. Note also that we only have two components of the combination therapy, i.e. the bridge and the growth factors. We need the third component, which is the axon growth inhibitor blockers (Nogo antibodies, Nogo receptor blockers, cethrin, chondroitinase, etc.).

    We are currently doing the lithium phase 1, i.e. giving patients with chronic spinal cord injury a 6-week course of lithium. We will then do a lithium phase 2, where we will randomize the patients to lithium or placebo and see if it improves neurological funciton. We will also carry out a phase 2 cord blood cell transplant trial. And then we will do the phase 3.

    Wise.



    may show that umbilical cord blood cells alone are effective. This is a possibility since several animal studies suggest that this is so. It may show that the cells don't do anything on their own. It is possib

    Wise.
    HI! Anything is possible Dr. Young.

  6. #96
    Quote Originally Posted by spidergirl
    \

    Yeah. I wonder how much dineros he paid for NOTHING. Like the big NOTHING from the movie The Neverending Story.

    We still are several years away there is no denying that. I just can't think about it anymore, it's so brainwracking that you have one life and one body and we become the exception to every rule.
    That's why i've started my own research.

    I'm also using combination therapies. Except my therapy consists of
    a combination of malt liquor, loretab, and ambien.

    I'm currently in phase 1 of my 3 phase clinical trials. It seems that
    Hurricane Ice, in combination with ambien has been successful before
    bed, if you're trying to create a "floating" feeling.

    However, this therapy will make operating a wheelchair or a toothbrush,
    exceedingly difficult.

  7. #97
    Quote Originally Posted by lynnifer
    And therein lies the crux of the problem ... there are so many conflicting ideas. One doctor says one thing, another says something totally different. Just in the other thread I posted about FES, Dr Young said everyone should try it. I emailed the Cleveland Clinic for FES a year ago and they said don't bother ...
    Lynnifer,

    The problem is evidence, not what one doctor says and another says. There are of course different levels of evidence and anything that is "cutting edge" will not have enough evidence. Otherwise, it would be "an established therapy".

    In the case of flaccid muscles, I hope that I made it very clear that my views are very different from the rest of the rehabilitation world. It is based on observations of patients and also from the work of the Swiss and Austrian doctors who have shown that intense high amplitude current stimulation can restore flaccid muscles, contrary to what many doctors thought for years. In addition, there will be some doctors who will think that such FES stimulation is not worthwhile, even if it could restore muscle bulk and activity. These same doctors are the ones that are quick to recommend amputation for a decubitus ihn the feet because they say that you are not going to need your legs anyway.

    I happen to disagree with these doctors because I have seen a number of people with ASIA A lower thoracolumbar injuries recover walking. Granted it is not great walking and it does not happen to everybody but I disagree with physiatrists and therapists who say that people with flaccid muscles in the lower extremities should not have any exercise or make any attempt to stand and walk.

    This should not be a me against them thing. People should evaluate the evidence and the arguments. If my arguments and evidence are convincing, then you should believe me. If their arguments and evidence are convincing, then believe them. You also have to evaluate the expertise of the persons. I have to say that the Cleveland Clinic is very experienced with intramuscular stimulation. Hunter Peckham, the head of the Cleveland FES center, is one of my best friends. I respect his opinion. If he says that it is not worthwhile, I would take it seriously. I would ask him why not. He may be right for certain conditions. We would have a good discussion about it, I think.

    Wise.

  8. #98
    Senior Member lynnifer's Avatar
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    Buck ... priceless ... lol.
    Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.

    T-11 Flaccid Paraplegic due to TM July 1985 @ age 12

  9. #99
    Quote Originally Posted by spidergirl
    HI! Anything is possible Dr. Young.
    I hope that it is more than "anything is possible". I believe that the clinical trial has a high likelihood of showing beneficial effects on people with chronic spinal cord injury or else I would not be doing this.

    Wise.

  10. #100
    Senior Member spidergirl's Avatar
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    Quote Originally Posted by Wise Young
    I hope that it is more than "anything is possible". I believe that the clinical trial has a high likelihood of showing beneficial effects on people with chronic spinal cord injury or else I would not be doing this.

    Wise.
    I aleady know this. I always give you the benefit of the doubt regardless. I just can't deal with the UTI's anymore. They have substantially taken a toll on me. I work everyday and it's very uncomfortable to have to wear some sort of serentity pad or whatever so I don't pee all over people's couch's in the studio. And not to mention I have to wear clothes that go over my jeans or pants somewhat. ( actually this is a fad right now so that's a plus) It's just so ridiculous. Maybe we can get BBS back again at the very least. Is it weird that I haven't passed gas since my injury? Is that bad? Someone told me my cord was severed because of that and I have clearly seen my MRI's several times to know I have a contusion.

    I remember my nanny saying to me once when I was younger that passing gas is very healthy and that means that your body is functioning properly.

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