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Thread: Spinal Cord Injury Network USA (SCINetUSA)

  1. #401
    Quote Originally Posted by t8burst View Post
    Wise,

    In your trials as I understand it you only do one injection of UCBMC/Li. Why only one? Do you see any possible benefits of multiple injections? From my layman's understanding it wouldn't increase the rate of recover but could possibly increase the amount of fibers attempting to cross the injury site.

    This is also a general observation of other stem cell treatments I have read about (not an exhaustive study, so I may be way off base). It looks like in most cases a researcher drops a weight on a rat's back, shoot his/her little rat spine with something then watches what happens. Is there simply no benefit for repeated application of stem cells?

    Thanks.
    T8burst,

    Sorry about not answering your question earlier.

    In the United States, giving two injections to people over time will require an additional surgery and each surgical procedure will likely cost about $50,000. Two injections will cost $100,000. By the way, it is not so easy or cheap to do experiments in animals either. The manpower required for animal experiments is enormous. Each anesthesia and laminectomy, particularly in rats that have already been spinal-injured, will result in some mortality. Let me give an example of what it would take to undertake an experiment to compare the efficacy of one versus two cell injections into the spinal cord of rats with chronic spinal cord injury.

    Suppose you are just comparing surgery with no injections, surgery with one injection of cells, and surgery with two injections of cells each separated by a month. Even with our NYU contusion model, which is the most precise and most efficient model in the field, you should do about 12 animals per treatment group to detect a 10% difference in locomotor score (assuming 1-2 mortalities per group). You have to have concurrent controls. So, the experiments would require 5 groups of 12 rats = 60 rats, i.e. control injury with no injection, control 1 injection, treatment 1 injection, control 2 injections, treatment 2 injections.

    Imagine taking care of 60 rats for 14 weeks (6 weeks when they are "chronic", treat them, and then another 8 weeks to see the effects of the therapy). You have to squeeze their bladders every day. Let's say it takes you 5 minutes to inspect and squeeze each rat. This means that, if you are very efficient and champion rat squeezer, you can do 12 rats an hour and it will take you 5 hours to squeeze all 60 rats once a day without any breaks. You of course have to give them antibiotics and other treatments if you find that they have infections or neuropathic pain. You may have to squeeze some rats twice a day, if you fail the first time. This has to happen 7 days a week. Just bladder care of the rats alone will require two full-time experienced animal caretakers.

    The surgery for spinal cord injury and the surgery to expose the spinal cord for injecting the cells will each take 2-3 hours per rat. So, 3-4 surgeries will take up a whole day. In a week, if you operate 8 hours a day for 5 days, you can operate on at most 20 rats. A good surgeon will require at least 3 weeks to operate on 60 rats to do the spinal cord injury. At 6 weeks and 10 weeks after injury, the surgeon will have to re-anesthetize the rats and go through 3 weeks of surgery to treat the rats with the first injection and the rats against with the second injection. To assess walking of the animals, you have to examine each animal once a week. Finally, you have to anesthetize the rat, perfused it, remove the spinal cords, post-fix the spinal cords, section and stain the spinal cords, photograph the sections with a microscope, and analyze the data. A good technician can perhaps analyze the spinal cord of two rats a week.

    So, a team of 5 people are required for this study for 6 months, i.e. two animal care technicians, one surgeon, one histologist/pathologist, and one supervising investigator. By the way, the cost to do such an experiment will cost as much as $312,000, assuming 44% fringe benefit rates. If you get a grant from the NIH to do such an experiment, the cost will be $500,000, assuming 60% indirect cost rates. I attach a spreadsheet of a sample budget.

    So, it is an expensive proposition to test and show that multiple injections are better than one. I agree with you that it needs to be done, however. One of the things that we are hoping to do in our clinical trial is to include patients who have already been in our trials and then enrolling them in a trial again for when their recovery comes to a plateau, to see if their improvements are boosted by a second or even a third transplant.

    Wise.
    Last edited by Wise Young; 04-17-2013 at 06:48 AM.

  2. #402
    Moderator jody's Avatar
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    It would be cool if someone could drop a few of those cells in when I have my laminectomy.
    I need one no matter what, so couldn't that be possible?

  3. #403
    Quote Originally Posted by jody View Post
    It would be cool if someone could drop a few of those cells in when I have my laminectomy.
    I need one no matter what, so couldn't that be possible?
    Jody,

    I am hoping that this will be one of the practices... that doctors would inject some cells into the spinal cord when there is opportunity such as a laminectomy. Unfortunately, we must do the transplants only as part of a clinical trial until the cells are approved as a therapy.

    Wise.

  4. #404
    Quote Originally Posted by Barrington314mx View Post
    Whats the fundraising tally up to?
    Barrington, I have to submit a formal request to our business office and would rather wait until after our big Fighting for the Cure event next month.

  5. #405
    Quote Originally Posted by Jim View Post
    Barrington, I have to submit a formal request to our business office and would rather wait until after our big Fighting for the Cure event next month.
    Any update along those lines Jim? Thanks!

  6. #406
    Which centers are currently part of SCInetUSA?

    Paolo
    In God we trust; all others bring data. - Edwards Deming

  7. #407
    There are 4 centers within NJ, NY & PA.

    Dr. Young will say more when appropriate.

  8. #408
    Quote Originally Posted by Jim View Post
    There are 4 centers within NJ, NY & PA.

    Dr. Young will say more when appropriate.
    Jim,

    thanks for your response, but I am afraid this is very disappointing.
    Unfortunatly I have to note it has been 5 years since SCInetUSA has been formed and still no clinical trial is in sight, therefore I would like to have the money I have donated back.
    If you need a copy of the receipts let me know.

    Paolo
    In God we trust; all others bring data. - Edwards Deming

  9. #409
    Senior Member lunasicc42's Avatar
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    Quote Originally Posted by paolocipolla View Post
    Jim,

    thanks for your response, but I am afraid this is very disappointing.
    Unfortunatly I have to note it has been 5 years since SCInetUSA has been formed and still no clinical trial is in sight, therefore I would like to have the money I have donated back.
    If you need a copy of the receipts let me know.

    Paolo

    I understand what you are saying and the point that you are trying to make ,but in reality and from a legal standpoint.....fat chance
    "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

  10. #410
    Quote Originally Posted by lunasicc42 View Post
    I understand what you are saying and the point that you are trying to make ,but in reality and from a legal standpoint.....fat chance
    I think from a legal standpoint to win you have to be able to prove that your decision to donate was based on inetnetionally misleading informations provided to you from people who got the donation.
    This might be hard in this case, but if (accidentally) there is someone with SCI who is also a lowyer and that also donated to "just-a-dollar-please" he/she might consider working on this perspective.

    Mine is just a friendly request.

    Paolo
    Last edited by paolocipolla; 04-10-2014 at 09:01 AM.
    In God we trust; all others bring data. - Edwards Deming

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