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    Originally posted by ay2012 View Post
    Just wondering if everything was on track to submit the IND application by the end of this month, as previously stated/hoped....? Thanks!
    We are still working on it. Wise.

    Comment


      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.

      Originally posted by Wise Young View Post

      What I believe we are seeing in our trial now is regeneration. Long fiber tracts are regrowing long distances in the spinal cords and they appear to be making some synaptic connections with distal motor structures at 6-18 months after umbilical cord blood transplants. At least in initial stages, subjects are showing improved walking without much change in motor and sensory scores.

      Wise.

      Comment


        Originally posted by Wise Young View Post
        We are still working on it. Wise.

        PROFESSOR
        you work for an IND with any combination therapy UCB+LITHIUM+CETHERIN?


        AND IN WHICH CITY IN USA?

        WHEN YOU GO AND HAVE APPROVAL FOR Begin?

        Comment


          Originally posted by fti View Post
          PROFESSOR
          you work for an IND with any combination therapy UCB+LITHIUM+CETHERIN?


          AND IN WHICH CITY IN USA?

          WHEN YOU GO AND HAVE APPROVAL FOR Begin?
          No, it's just for UCB and lithium. And they have to receive a response at most three months after submitting the IND.

          Comment


            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.

            I was under the impression that they are doing 4 injections, 2 above the injury site on each side of the cord and 2 injections below...

            Or do you mean second round of injections?
            "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
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            Comment


              Correct lunasicc42, thats about all that will fit. Additional injections may be considered depending on the results.
              Last edited by Jim; 24 Jan 2013, 2:14 PM.

              Comment


                Originally posted by lunasicc42 View Post
                I was under the impression that they are doing 4 injections, 2 above the injury site on each side of the cord and 2 injections below...

                Or do you mean second round of injections?
                The latter.

                Comment


                  Originally posted by t8burst View Post
                  The latter.
                  I asked this question before. Dr. Young said they would want/need to wait over a year post therapy to consider doing it again... And multiple injections would likely require their own set of trials.

                  Comment


                    Originally posted by ay2012 View Post
                    I asked this question before. Dr. Young said they would want/need to wait over a year post therapy to consider doing it again... And multiple injections would likely require their own set of trials.
                    Thanks. I realize that some things don't get proportionally better the more you take them (you don't take 50 aspirin to get rid of a migraine) but I saw a show on how they grew a pig heart in a bath of stem cells and it seemed like something like a pump like a baclophen pump into the injury site of stem cells would be an interesting concept.

                    Comment


                      Whats the fundraising tally up to?

                      Comment


                        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; 17 Apr 2013, 6:48 AM.

                        Comment


                          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?

                          Comment


                            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.

                            Comment


                              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.

                              Comment


                                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!

                                Comment

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