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Dr. Jerry Silver: Latest chronic SCI research results featured at Cleveland

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    #31
    Originally posted by GRAMMY View Post
    For those interested in that sort of thing, it may be worth a few minutes to contact your state representatives where the right to try bills are underway and tell them you support the measure. PA happens to be one of the states in the process with HB1104. https://legiscan.com/PA/bill/HB1104/2015
    Thank you Grammy, they're tired of me but they can't lock their doors.

    Comment


      #32
      Originally posted by nrf View Post
      Thank you Grammy, they're tired of me but they can't lock their doors.
      Yes, but they were the ones at the lectern promising to get it done. There is no rest for those that we voted into office.
      http://spinalcordresearchandadvocacy.wordpress.com/

      Comment


        #33
        Dr Silver, I have few questions:
        - What would be the fastest & safest way to deliver Cha'se + Peptide to humans - I guess with micro-injections ?
        - If this therapy (to restore breathing) proven effective on humans, do you expect
        accelerated human testing for similar Cha'se + Peptide approach for other levels of chronic SCI.
        - Also - realistically - how long large animal testing procedure can take?
        Thank you very much for your time and for your work!!!!!
        www.MiracleofWalk.com

        Miracles are not contrary to nature, but only contrary
        to what we know about nature
        Saint Augustine

        Comment


          #34
          Dr. Silver, thank you so much for taking the time to answer our questions!

          Kind of a weird one here. I have a C1-C2 injury, complete, so the restoration of normal breathing is, well, hard to even imagine after almost 25 years now. I've been using a phrenic pacer for nearly that long, the Atrostim version, and I'm wondering how and if that would impact a possible treatment like the one you're working on?

          Thanks again for taking on the chronic cause. It really means a lot.

          Comment


            #35
            Originally posted by comad View Post
            Dr Silver, I have few questions:
            - What would be the fastest & safest way to deliver Cha'se + Peptide to humans - I guess with micro-injections ?
            - If this therapy (to restore breathing) proven effective on humans, do you expect
            accelerated human testing for similar Cha'se + Peptide approach for other levels of chronic SCI.
            - Also - realistically - how long large animal testing procedure can take?
            Thank you very much for your time and for your work!!!!!
            Good questions

            Ch'ase is administered via micro-injections to the appropriate levels of the cord depending on which behaviors one is targeting for recovery. For breathing, the target is around C4, for arm/hand function C5-8, for walking L2 (the location of the CPG) and bladder/bowel/ sexual function lower lumbar L4,5 + upper sacral. There is a possibility to target multiple cord levels simultaneously with the enzyme. The ISRT is now working on state of the art controlled AAV vector delivery systems for the enzyme. This will give us a long acting, highly potent and widespread delivery system that can be turned off when behavioral improvements plateau. I am extremely optimistic that they will be successful. They are a wonderful and dedicated group. The peptide (or a small molecule substitute that is now being developed) is delivered systemically either via su-cutaneous injections or maybe in the future via oral administration.

            I do believe that the respiratory system is not unique in its ability to sprout slowly after injury. I am very optimistic about improving arm/hand function. We should be able to target other levels of the cord as mentioned above. For those with complete cord lesions we will need to build a bridge across the lesion scar and we are now working on that with with a combination of peripheral nerve grafting, Ch'ase and our peptide. We have had great success using our bridging strategy over the years and we are now focused on repeating this in chronic models. The bridging work is funded by a grant from the NIH.

            Large animals are a bit of a hurdle due to cost. I have colleagues who are quite interested in testing our strategy in mini-pigs and primates. I would very much like to move to primates before humans because of their human-like hand function. Unfortunately, they are telling me that the cost is about a million and half bucks (100K per animal, good grief). It should not take too long once the experiments begin.

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              #36
              I'm afraid nothing will happen until someone decides to take a risk. I am not a neuroscientist. I cannot replicate the drug. I am but one sample, willing to risk my life, to see if your hypothesis is correct. At some point the pain and misery will cause my demise. Why waste the opportunity to learn?

              I pay taxes and am a part owner (assuming public funds are used) of this technology. It's my body. We are all human beings. Why can't we work together to try to apply the latest technology to reduce my suffering? I have a brain capable of collobrating on a path forward. Why are we completely dismissed as though we are retarded and cannot make decisions about therapies?

              SCI patients are more than Christopher Reeve inspirational monkees whose purpose is to raise money. I have to have your collaboration as you know the work. Is it that the source of the research money has to maximize potential profits making sure the therapy is completely defined before helping people?

              How hard can this be? The drug is defined. Pick a dosage based on known information. INJECT. I write the check and go home!

              Comment


                #37
                Originally posted by jsilver View Post
                Good questions
                ...
                I do believe that the respiratory system is not unique in its ability to sprout slowly after injury. I am very optimistic about improving arm/hand function. We should be able to target other levels of the cord as mentioned above. For those with complete cord lesions we will need to build a bridge across the lesion scar .....
                Thank you for your answers, Dr Silver!

                In above quote you've said that you will work on building bridges for complete injury.
                Is this mean that INCOMPLETE CHRONIC injuries might have even larger chance for recovery using this method?

                Also, if 1.5 Million (15 animals x $ 100K needed for primates testing step) is obstacle to achieve this research
                to become human trial - should this community start screaming around for donations and more media attention??!?
                www.MiracleofWalk.com

                Miracles are not contrary to nature, but only contrary
                to what we know about nature
                Saint Augustine

                Comment


                  #38
                  Originally posted by Scaper1 View Post
                  Dr. Silver, thank you so much for taking the time to answer our questions!

                  Kind of a weird one here. I have a C1-C2 injury, complete, so the restoration of normal breathing is, well, hard to even imagine after almost 25 years now. I've been using a phrenic pacer for nearly that long, the Atrostim version, and I'm wondering how and if that would impact a possible treatment like the one you're working on?

                  Thanks again for taking on the chronic cause. It really means a lot.
                  Not weird at all. Thanks for asking. If you listened to the last part of my seminar, you learned that a single injection of chondroitinase has produced remarkable recovery of breathing 1.5 years after C2 hemisection injury in a rat model. That's a very old rat. However, importantly, this model has spared fibers on the other side of the spinal cord that can serve as a substrate for sprouting. Thus, an incomplete injury will respond better to the enzyme treatment than a complete injury. However, so-called complete injuries also most often have some spared axons that are not in sufficient numbers to elicit function. They can still serve as a substrate for enzyme induced sprouting. If we can show that the microinjection of the enzyme does no further harm, and given the 1.5 year data, then it would be reasonable to try this even in people with long-standing injuries like yours. We have also published extensively on the use of peripheral nerve bridges +chondroitinase to restore breathing in an acute rat model (Nature magazine, 2011). However, bridge building in the cord is problematic at C2 in humans because of the possibility of doing additional damage. Again, if we can show efficacy of bride building at chronic stages then who knows what good may happen.

                  Comment


                    #39
                    Originally posted by comad View Post
                    Thank you for your answers, Dr Silver!

                    In above quote you've said that you will work on building bridges for complete injury.
                    Is this mean that INCOMPLETE CHRONIC injuries might have even larger chance for recovery using this method?

                    Also, if 1.5 Million (15 animals x $ 100K needed for primates testing step) is obstacle to achieve this research
                    to become human trial - should this community start screaming around for donations and more media attention??!?
                    Yes, for certain, incomplete chronic injuries are far more likely to respond best to the enzyme. As for money raising it is always appropriate for the SCI community to help call attention to and help raise funds for scientifically excellent research. One good way of identifying the very best SCI related science is to browse the Unite2Fight Paralysis web site. They do a wonderful job of calling attention to the good stuff.

                    Comment


                      #40
                      Dr. Silver--Looking down the road after successful large animal trials, when beginning to test with humans, how do you envision the combined Ch'ase and peptides will be administered into the spinal cord? Surgery, injections, pills, intravenous? Oops, just read above which answers this question.

                      Would this be a one time and done, or would the procedure require multiple attempts due to the time it takes to degrade the glial scar?

                      Comment


                        #41
                        Originally posted by jsilver View Post
                        Good questions

                        Large animals are a bit of a hurdle due to cost. I have colleagues who are quite interested in testing our strategy in mini-pigs and primates. I would very much like to move to primates before humans because of their human-like hand function. Unfortunately, they are telling me that the cost is about a million and half bucks (100K per animal, good grief). It should not take too long once the experiments begin.
                        You won't be able to do that in North America or will you?
                        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

                        Comment


                          #42
                          Originally posted by 6 Shooter View Post
                          Dr. Silver--Looking down the road after successful large animal trials, when beginning to test with humans, how do you envision the combined Ch'ase and peptides will be administered into the spinal cord? Surgery, injections, pills, intravenous? Oops, just read above which answers this question.

                          Would this be a one time and done, or would the procedure require multiple attempts due to the time it takes to degrade the glial scar?
                          The enzyme is administered through micro-needles but the number of injections per area that would adequately cover the cord still needs to be worked out in a larger animal model. In our rat model we only administer a single injection at C4. When the viral vectors are perfected they spread much farther than regular ch'ase. Thus, perhaps only a single injection will be needed even in a larger animal per targeted area. The peptide is given systemically and can be administered for as long as needed. A critical adjunct to the therapy can be physical rehab or epidural stimulation.

                          Comment


                            #43
                            Originally posted by lynnifer View Post
                            You won't be able to do that in North America or will you?
                            No problem of doing these experiments in the US. We just need the cooperation of a university with a good primate facility.

                            Comment


                              #44
                              It is nice to hear promising research going on, and even more nice to have the one administering it communicating with us! Thank you Dr. Silver and keep up the good work!
                              www.symbolofstrength.com

                              Comment


                                #45
                                Dr. Silver,
                                Thank you for responding and engaging our community through this channel. I am excited about this peptide and the Ch'ase developments.

                                A few questions:
                                1) Can you give us an actual estimate for a timeframe when Ch'ase will start Human Trials. (I.e.: 6mo, 1yr, 3yrs, you cannot comment because of confidentiality or uncertainty, or a more in depth explanation than ISRT is developing a delivery method) People here and myself want hear a definitive answer.
                                2) Can you give us a time estimate on the peptide as well, assuming it is effective and safe?
                                3) You mentioned Acorda Therapeutics in the Q&A. Can you give us some of their reasoning for why they are sitting on a Ch'ase patent without pursuing human trials? Is there patent issues that ISRT are going to run into or are having that are hindering progression for their Ch'ase version? What is being done to prevent this story from repeating?
                                4) What can we advocate to the government and industry to help you and others expedite this research?

                                Thank's!

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