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Thread: How much longer?

  1. #21
    Quote Originally Posted by -scott- View Post
    he's not far off.

    let's say a trial goes well.

    results will be peer-reviewed prior to publication.

    further research will likely be required.

    rinse, repeat.

    FDA approval won't happen overnight if there's any hope of treatment being available in the US.

    and then somehow the treatment will have to be marketed & funded.

    and doctors will likely have to be trained to treat.

    one successful trial won't guarantee availability of a cure.
    That is the sad truth.

  2. #22
    Senior Member Tim C.'s Avatar
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    Same 'ol responses

    Quote Originally Posted by Keith View Post
    I get so disgusted don't see any progress being made. I avoid coming back and looking to see what's happening for two months and when I do seems to be the same thing. Can someone put it in layman's terms where the most progress is. 15 years C3 complete. Numerous surgeries later for other complications lucky still to be here. On the verge of giving up. Completely tired of this situation.
    I'm generalizing for sure, but these seem to have common threads from my 10 yrs here.

    ABs reply : "Hang in there"

    The Paras say : "Get on with life, focus on what you can do, not what you can't"

    The Low Quads suggest : "Don't complain, join the March for the Cure; fundraise, letter write, visit Washington to demand change for us.

    The Scientists ask : "Define what you mean by cure."

    The Hi Quads declare : "Shit, don't you guys realize how friggin hard it is for us just to fight every day just to stay alive? We don't have the luxury to "hang in", or "get on", or "join forces", or to "consider what is, or isn't a cure". Our lives suck, and suck enough that at times we sometimes get tired of fighting every day.

  3. #23
    Senior Member lynnifer's Avatar
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    Quote Originally Posted by Tim C. View Post
    The Hi Quads declare : "Shit, don't you guys realize how friggin hard it is for us just to fight every day just to stay alive? We don't have the luxury to "hang in", or "get on", or "join forces", or to "consider what is, or isn't a cure". Our lives suck, and suck enough that at times we sometimes get tired of fighting every day.
    That's what needs to be seen by the public, politicians, scientists because you are right. Hold their feet to the fire!

    Signed a lowly para .. for 26yrs .. 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

  4. #24
    Quote Originally Posted by Tim C. View Post
    I'm generalizing for sure, but these seem to have common threads from my 10 yrs here.

    ABs reply : "Hang in there"

    The Paras say : "Get on with life, focus on what you can do, not what you can't"

    The Low Quads suggest : "Don't complain, join the March for the Cure; fundraise, letter write, visit Washington to demand change for us.

    The Scientists ask : "Define what you mean by cure."

    The Hi Quads declare : "Shit, don't you guys realize how friggin hard it is for us just to fight every day just to stay alive? We don't have the luxury to "hang in", or "get on", or "join forces", or to "consider what is, or isn't a cure". Our lives suck, and suck enough that at times we sometimes get tired of fighting every day.
    Well said Tim. Some people barely have a breath to hold.

  5. #25
    The more and the better the clinical trials being done, the better. This is just common sense. A few years ago, there was only Geron saying that they want to do clinical trials. Now, there is Stemcyte, Stem Cell Inc, and NeuralStem. I know of at least a dozen companies that have cells that they are anxious to try on patients with chronic spinal cord injury.

    I don't know if it will help people here for me to compare spinal cord injury with another stroke. Stroke occurs in 10 times more people than those who have spinal cord injury. I just went to a meeting called STEP3, where neurologists and neurosurgeons are getting together to discuss how they can get clinical trials going for stroke. There are no trials of any therapy for chronic spinal cord injury and most clinicians are skeptical that any therapy would help chronic stroke.

    It feels like deja vu for me. I was thrown back to 1991, when all these doctors and companies were getting together to say how they want to do spinal cord injury clinical trials. People were arguing about what preclinical data would be necessary before one can take a treatment to trial. There was no agreement concerning the best animal models and outcome measures.

    In spinal cord injury, we have progressed well beyond this point. We have the outcome measures, the experience in transplanting cells, and a lot mechanisms and animal data. In stroke, they still have to define what "chronic" stroke is, agree on the best outcome measures, and get clinicians excited about therapies for chronic spinal cord injury.

    Our main obstacle is funding for clinical trials. While many stem cell companies would like to do clinical trials on spinal cord injury, few had the money to do so. One company went through phase I/II trials for a promising therapy (Cethrin), licensed the treatment to a group to raise money for phase III, and they failed to raise the money for the trial.

    Actually, now is a great time for clinical trials of cell transplants into the spinal cord. The first therapy to show functional improvement in chronic spinal cord injury will make the history books and also put the company sponsor ahead of the pack. Once the first therapy has been shown to be effective, subsequently therapies will have to be compared against that therapy.

    By the way, ChinaSCINet is currently doing phase II trials on umbilical cord blood mononuclear cells and lithium. If the phase II trials indicating safety and a trend for efficacy, we will proceed to phase III trials in China, U.S., Norway, and India in 2012. By 2013, we will know whether it is effective or not. If it is effective, that is great. If not, we go on to other therapies.

    Wise.



    Quote Originally Posted by -scott- View Post
    he's not far off.

    let's say a trial goes well.

    results will be peer-reviewed prior to publication.

    further research will likely be required.

    rinse, repeat.

    FDA approval won't happen overnight if there's any hope of treatment being available in the US.

    and then somehow the treatment will have to be marketed & funded.

    and doctors will likely have to be trained to treat.

    one successful trial won't guarantee availability of a cure.

  6. #26
    Quote Originally Posted by Wise Young View Post

    Our main obstacle is funding for clinical trials. While many stem cell companies would like to do clinical trials on spinal cord injury, few had the money to do so. One company went through phase I/II trials for a promising therapy (Cethrin), licensed the treatment to a group to raise money for phase III, and they failed to raise the money for the trial.

    Wise.
    Dr. Young, what is the cost of a clinical trial. I guess it will dependo on each case and it may be too difficult to estimate, but can you give an estimate? For example, this clinical trial of Cethrin, what wold be an estimate of its cost?
    Thank you.

  7. #27
    why did not the rhf support cethrin?

  8. #28
    Quote Originally Posted by maf View Post
    Dr. Young, what is the cost of a clinical trial. I guess it will dependo on each case and it may be too difficult to estimate, but can you give an estimate? For example, this clinical trial of Cethrin, what wold be an estimate of its cost?
    Thank you.
    I don't know about the Cethrin trial but I have estimated the cost of our SCINetUSA trial for umbilical cord blood mononuclear cells and lithium trial will be over US$100,000 per subject and this does not include the cost of treatment which is being donated by Stemcyte. If we were to add the cost of the cells and , it would probably be close to $150,000 per subject.

    So, for 20 subjects in the phase 2 trial in Brackendridge, we have to raise $2 million. For the 120 subjects in the phase 3 trials later in 2012, we have to raise $12 million. We may need more than this because there will be other expenses associated with a multicenter trial.

    Wise.

  9. #29
    It just seems to me that the scientist community has know real idea's on how to raise the money needed. 10 million is peanuts to raise for our project. What they need to do is hire a ex politician with good connections and fine the right politician or two to support their campaign funds. I would bet if you guy's were funding obama campaign 100 million would of been easy to get. He would be pushing it as one of his needed target that must be solved. He could have ex iraq vets with spinal cored injuries as one of the big reasons.

  10. #30
    .....
    Last edited by Barrington314mx; 12-09-2011 at 09:08 AM.

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