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Thread: Now what?

  1. #161
    "You assume that we must have animal data showing efficacy in animal models before we go ahead to clinical trial. It is true that you must have such efficacy data if you are trying to get NIH funding for a trial. However, the FDA itself does not care whether you have efficacy data as long as you have good safety data and a strong rationale for testing the therapy."

    I would have assumed that too. Why go to human trials if you don't have efficacy in animal trials? It would seem pointless and unfair on the human subjects.

  2. #162
    Quote Originally Posted by Christopher Paddon View Post
    "You assume that we must have animal data showing efficacy in animal models before we go ahead to clinical trial. It is true that you must have such efficacy data if you are trying to get NIH funding for a trial. However, the FDA itself does not care whether you have efficacy data as long as you have good safety data and a strong rationale for testing the therapy."

    I would have assumed that too. Why go to human trials if you don't have efficacy in animal trials? It would seem pointless and unfair on the human subjects.
    I am equally curious. I hope I am misunderstanding but without some proof of efficacy, why subject humans to a highly speculative procedure that has not been tried first in animal models?
    My blog: Living Life at Butt Level

    Ignite Phoenix #9 - Wheelchairs and Wisdom: Living Life at Butt Level

    "I will not die an unlived life. I will not live in fear of falling or catching fire. I choose to inhabit my days, to allow my living to open me, to make me less afraid, more accessible, to loosen my heart until it becomes a wing, a torch, a promise. I choose to risk my significance; to live so that which comes to me as seed goes to the next as blossom and that which comes to me as blossom, goes on as fruit."

    Dawna Markova Author of Open Mind.

  3. #163
    Some refreshment:
    Quote Originally Posted by Wise Young View Post
    Yes, we have tested the treatment in a chronic model. We found that cyclosporin, a drug that we have to use to prevent immune rejection of the transplanted cells blocks the effects of lithium on the transplanted cells. If we don't use cyclosporine, the cells will be rejected. We don't have HLA matching of rats. so, we can't test the treatment in rats. In humans, we can transplant HLA matched cord blood and don't have to use immunosuppression. ...


    Wise.

  4. #164
    Quote Originally Posted by JenJen View Post
    I am equally curious. I hope I am misunderstanding but without some proof of efficacy, why subject humans to a highly speculative procedure that has not been tried first in animal models?
    Jenjen and Chris,

    We testing umbilical cord blood cells, which over a dozen independent laboratories have been shown to improve function in animal spinal cord injury models as late as 6 months after injury. Several groups are now offering umbilical cord blood cell therapies to people with chronic spinal cord injury. Lithium has also been shown to regenerate the spinal cord and improve neurological function in animals with spinal cord injury.

    In our trial, we are asking the question whether umbilical cord blood cells alone is beneficial and whether lithium enhances its effects. Both treatments are safe either separately or together.

    Wise.

  5. #165
    Senior Member Foolish Old's Avatar
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    Quote Originally Posted by Wise Young View Post
    Jenjen and Chris,

    We testing umbilical cord blood cells, which over a dozen independent laboratories have been shown to improve function in animal spinal cord injury models as late as 6 months after injury. Several groups are now offering umbilical cord blood cell therapies to people with chronic spinal cord injury. Lithium has also been shown to regenerate the spinal cord and improve neurological function in animals with spinal cord injury.

    In our trial, we are asking the question whether umbilical cord blood cells alone is beneficial and whether lithium enhances its effects. Both treatments are safe either separately or together.

    Wise.
    Wise, does the cord blood/Lithium treatment show any promise of being able to treat chronic SCI? Spina Bifida? Sorry if you've answered this previously. If you have, I'd be grateful for a link or a search term that leads me to that answer.

    I tire of reading long threads offering little in conclusion. As you know, I'm a simple man with poor grasp of complexity. I do appreciate simple, direct answers, no matter how speculative.
    Last edited by Foolish Old; 06-29-2012 at 11:35 AM.
    Foolish

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  6. #166
    Quote Originally Posted by Wise Young View Post
    Jenjen and Chris,

    We testing umbilical cord blood cells, which over a dozen independent laboratories have been shown to improve function in animal spinal cord injury models as late as 6 months after injury. Several groups are now offering umbilical cord blood cell therapies to people with chronic spinal cord injury. Lithium has also been shown to regenerate the spinal cord and improve neurological function in animals with spinal cord injury.

    In our trial, we are asking the question whether umbilical cord blood cells alone is beneficial and whether lithium enhances its effects. Both treatments are safe either separately or together.

    Wise.
    Thank you for that. It appears I was unclear in my post and I think Chris was asking about the same think but I'll let him speak for his self. My question was about your future strategy to add Cethrin,
    My blog: Living Life at Butt Level

    Ignite Phoenix #9 - Wheelchairs and Wisdom: Living Life at Butt Level

    "I will not die an unlived life. I will not live in fear of falling or catching fire. I choose to inhabit my days, to allow my living to open me, to make me less afraid, more accessible, to loosen my heart until it becomes a wing, a torch, a promise. I choose to risk my significance; to live so that which comes to me as seed goes to the next as blossom and that which comes to me as blossom, goes on as fruit."

    Dawna Markova Author of Open Mind.

  7. #167
    wise, the six month period does'nt appyly to most on the forum. What is your expectations for long term chronics?

    anthony

  8. #168
    Quote Originally Posted by keeping on View Post
    wise, the six month period does'nt appyly to most on the forum. What is your expectations for long term chronics?

    anthony
    Six months in most animals is long term chronic.

  9. #169
    Quote Originally Posted by Wise Young View Post
    Jenjen and Chris,

    We testing umbilical cord blood cells, which over a dozen independent laboratories have been shown to improve function in animal spinal cord injury models as late as 6 months after injury. Several groups are now offering umbilical cord blood cell therapies to people with chronic spinal cord injury. Lithium has also been shown to regenerate the spinal cord and improve neurological function in animals with spinal cord injury.

    In our trial, we are asking the question whether umbilical cord blood cells alone is beneficial and whether lithium enhances its effects. Both treatments are safe either separately or together.

    Wise.
    Jen-Jen,

    Sorry, I was typing quickly and made a mistake. I did not mean 6 months. Many of the rat studies in rats were treated with umbilical cord blood cells at 2 weeks after injury. At two weeks, almost all the acute spinal cord injury processes should be over and the treatment is not protecting the spinal cord against secondary damage.

    Wise.

  10. #170
    Quote Originally Posted by KofQ View Post
    Six months in most animals is long term chronic.
    In rats, one week is equal to about a month in human. This is because rats have four times faster metabolic rates, heart rate, drug clearance, and cell growth rates than human. Most rats reach a plateau in their recovery by 6 weeks whereas most humans reach a recovery plateau at 6-18 months.

    Rats normally don't live longer than two years under optimal conditions and usually don't live longer than 3-6 months in the wild. Mice have even shorter lifespans. So, it is difficult to compare rodent and human time. So, six months in a rat would be similar to 6 years in a human.

    Wise.

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