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    Originally posted by KyleP2112 View Post
    The posts on here about the trial for chronic SCI was interesting...hopefully progress continues to be made.

    Dr. Young - Thank you for your hard work. Here's a question. Do you think chronic injuries that are near the breathing control center of the spinal cord will be especially hard to address?

    As my physiatrist said to me during an appt., "the last thing you need is to end up on a ventilator if something unexpected happens after cells are injected"...
    Because of the way we are injecting the cells into the spinal cord, i.e. above and below the injury site, we excluded patients who are C4 or higher from the study. The phrenic nucleus is located at C3-C4. We didn't want to inject cells into the spinal cord at C3. At the present, we are finding that injection of up to 16 µliters of cells into the dorsal root entry zone does not seem to be producing lasting neurological deficits above the injury site.

    If the phase III trial shows beneficial effects of the treatment is large cohorts of patients with cervical spinal cord injury, we are planning a trial to transplant the cells into the injury site and below the injury site (rather than above and below the injury site) in subjects that are C4 or higher. The risk vs. benefit ratio is too high until we have more evidence that the treatment is beneficial and safe.

    The planned phase III trial will compare untethering surgery alone with untethering surgery plus cell transplants. The trial will tell us whether or not the untethering surgery alone is beneficial in chronic spinal cord injury. To date, having seen some patients who have shown benefit from untethering surgery alone, I don't think that it is dangerous to expose the spinal cord and untether the spinal cord, even in high cervical spinal cord injuries. The operation of course needs to be done by an experienced and skilled neurosurgeon.

    Wise.

    Comment


      Dr. Young--could you please give a detailed description of the untethering surgery. Primarily what is done, what is removed, and what is expected to be accomplished. And, have you seen good results in chronics wiho are 5+ years post? Thanks.

      Comment


        Originally posted by 6 Shooter View Post
        Dr. Young--could you please give a detailed description of the untethering surgery. Primarily what is done, what is removed, and what is expected to be accomplished. And, have you seen good results in chronics wiho are 5+ years post? Thanks.
        Every untethering surgery is different. After spinal cord injury, adhesions develop between the spinal cord and surrounding tissues. Normally, the spinal cord is surrounded (in fact, floating in) by cerebrospinal fluid. Due to blood and inflammation, adhesions develop between the spinal cord and the arachnoid membrane that usually holds the cerebrospinal fluid surrounding the spinal cord. Adhesions between the spinal cord and arachnoid tend to be fine, filmy membranes that seem almost like nothing. But, it is enough to obstruct and divert cerebrospinal fluid flow. Occasionally, of course, you can get big solid scars.

        It is not clear to me how often and when untethering works or not works. I have seen several people get better after untethering surgery, with some return of function (although limited). In Kunming, they have untethered about 350 cases, of which about 50 were complete spinal cord injuries that were more than 1 year after injury. We are analyzing this data now. Because these are not randomized control studies, the percentage of recovery will not provide reliable information concerning what to expect in another population of subjects. In our phase III clinical trial, however, we will be assessing the effect of untethering alone in about 80 chronic AIS A subjects. So the trial should provide us with more information.

        Wise.

        Comment


          Thank you for the post...it helps to hear information like this from an expert like you Dr. Young.
          C4/5 incomplete, 17 years since injury

          "The trick is in what one emphasizes. We either make ourselves miserable, or we make ourselves happy. The amount of work is the same.” - Carlos Castaneda

          "We live not alone but chained to a creature of a different kingdom: our body." - Marcel Proust

          Comment


            The problem I have being a quad, is that this clinical trial being done now has basically nothing to do with getting arms, hands and fingers back. This will have to be a whole separate trial of its own involving neuron replacement which has yet to be used or tried as any type of therapy, or trial. So, doing any kind of injection in the cervical cord is to try to reconnect a sliver of nerves so we can maybe wiggle some toes, twitch a leg, trickle some urine and maybe, just maybe, make alittle noise between our cheeks... Now, I'm not saying this is a bad thing, but for a paraplegic, this can be exciting. For a quadriplegic to be excited, there will have to be a complete separate trial of its own. Right now, I don't believe that there is any such thing that I'm aware of? There is such a long road ahead for us quads as far as starting a trial that will replace damaged white matter. I do hope for the best outcome, but I just cannot imagine possibly standing with my arms dangling, this is just not exciting to me. Best of luck to all present and future trials....

            Comment


              Originally posted by rukiddingme View Post
              The problem I have being a quad, is that this clinical trial being done now has basically nothing to do with getting arms, hands and fingers back. This will have to be a whole separate trial of its own involving neuron replacement which has yet to be used or tried as any type of therapy, or trial. So, doing any kind of injection in the cervical cord is to try to reconnect a sliver of nerves so we can maybe wiggle some toes, twitch a leg, trickle some urine and maybe, just maybe, make alittle noise between our cheeks... Now, I'm not saying this is a bad thing, but for a paraplegic, this can be exciting. For a quadriplegic to be excited, there will have to be a complete separate trial of its own. Right now, I don't believe that there is any such thing that I'm aware of? There is such a long road ahead for us quads as far as starting a trial that will replace damaged white matter. I do hope for the best outcome, but I just cannot imagine possibly standing with my arms dangling, this is just not exciting to me. Best of luck to all present and future trials....
              is this try D.r young?
              will quads benefit from your trial?

              thanks

              Comment


                Originally posted by Wise Young View Post
                In our phase III clinical trial, however, we will be assessing the effect of untethering alone in about 80 chronic AIS A subjects. So the trial should provide us with more information.

                Wise.
                Dr. Young, in addition to untethering, has there been any consideration of doing a lateral myelotemy to wash out the injury site in order to remove damaged tissue? I was watching a video on youtube ("Spinal Cord Injury: Is the Cure in China?" presented by Dr. Wise Young) of a presentation you gave where you mentioned this being done in China to insert Fetal Schwann cells into the injury site. I got the impression that just washing out the injury site inside the spinal cord was beneficial.

                Comment


                  Originally posted by Fragile View Post
                  Dr. Young, in addition to untethering, has there been any consideration of doing a lateral myelotemy to wash out the injury site in order to remove damaged tissue? I was watching a video on youtube ("Spinal Cord Injury: Is the Cure in China?" presented by Dr. Wise Young) of a presentation you gave where you mentioned this being done in China to insert Fetal Schwann cells into the injury site. I got the impression that just washing out the injury site inside the spinal cord was beneficial.
                  Fragile, the lateral myelotomy is really only beneficial during the subacute phase after spinal cord injury, not in the chronic phase. The evidence that fetal Schwann cells are beneficial is not clear. The group at Kunming showed that the lateral myelotomy alone appears to be beneficial without the cell transplants. In any case, those results need to be confirmed with controlled studies as well. Wise.

                  Comment


                    Originally posted by rukiddingme View Post
                    The problem I have being a quad, is that this clinical trial being done now has basically nothing to do with getting arms, hands and fingers back. This will have to be a whole separate trial of its own involving neuron replacement which has yet to be used or tried as any type of therapy, or trial. So, doing any kind of injection in the cervical cord is to try to reconnect a sliver of nerves so we can maybe wiggle some toes, twitch a leg, trickle some urine and maybe, just maybe, make alittle noise between our cheeks... Now, I'm not saying this is a bad thing, but for a paraplegic, this can be exciting. For a quadriplegic to be excited, there will have to be a complete separate trial of its own. Right now, I don't believe that there is any such thing that I'm aware of? There is such a long road ahead for us quads as far as starting a trial that will replace damaged white matter. I do hope for the best outcome, but I just cannot imagine possibly standing with my arms dangling, this is just not exciting to me. Best of luck to all present and future trials....
                    Only 25% of the 20 subjects in the trial were cervical spinal cord injuries. We have not analyzed upper limb function separately from lower limb function in subjects with cervical spinal cord injuries. So, I don't know and have not indicated whether there is any change in hand function. I think that you are jumping to conclusions that are not yet warranted.

                    Wise.

                    Comment


                      Originally posted by Wise Young View Post
                      Only 25% of the 20 subjects in the trial were cervical spinal cord injuries. We have not analyzed upper limb function separately from lower limb function in subjects with cervical spinal cord injuries. So, I don't know and have not indicated whether there is any change in hand function. I think that you are jumping to conclusions that are not yet warranted.

                      Wise.

                      I don't think I'm jumping to conclusions after reading many of your posts. You did mention that you were working on something in your lab regards to high injuries (neuron replacement) which would be needed for cervical SCI. Just injecting UCBC + Lithium is a far reach for high injuries, thats why only 25% of such a small number were cervical SCI in those trials. The reason for 25% of those 20 subjects, was to see if you could get a few nerves to activate the walking generator. When will you be analyzing this little percentage group for limb function? Will there be any trials in the pipeline that will concentrate on arm/hand function in the distant future? Enquiring Quads want to know.....

                      Comment


                        Originally posted by rukiddingme View Post
                        I don't think I'm jumping to conclusions after reading many of your posts. You did mention that you were working on something in your lab regards to high injuries (neuron replacement) which would be needed for cervical SCI. Just injecting UCBC + Lithium is a far reach for high injuries, thats why only 25% of such a small number were cervical SCI in those trials. The reason for 25% of those 20 subjects, was to see if you could get a few nerves to activate the walking generator. When will you be analyzing this little percentage group for limb function? Will there be any trials in the pipeline that will concentrate on arm/hand function in the distant future? Enquiring Quads want to know.....
                        Where have you read that quads will need neuronal replacement?
                        Neuron replacement would be necessary for brachial plexus and
                        cauda equina injuries. But I've never heard that a pure spinal cord
                        injury would need neuronal replacement.

                        Comment


                          I think you are mistaken rukm, lumbosacral injuries will require neuronal replacement, not high cervical injuries.

                          Comment


                            Buck503, Jim,


                            Here's what I found regarding neuron replacement for lower injuries as well as cervical. I need to correct myself, it's gray matter, not white..

                            https://www.carecure.net/forum/showp...postcount=1656

                            Comment


                              So.... Given that all the six month follow up data was collected by the end of November, I'm guessing the twelve month follow up should all be collected by now/is being collected now? Then a few more months for analysis and waiting for a publication?

                              Comment


                                you are in the ballpark...

                                Comment

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