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Why Walking is An Outcome Measure in the ChinaSCINet and SCINetUSA trials?

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    Why Walking is An Outcome Measure in the ChinaSCINet and SCINetUSA trials?

    Many people have asked me why we have chosen walking outcome measure, particularly WISCI (Walking Index of Spinal Cord Injury), as a secondary outcome measure in people in the planned ChinaSCINet and SCINetUSA trials after umbilical cord blood mononuclear cell and lithium therapies. Some people think that walking is the ultimate measure of functional recovery and may be too difficult to achieve. Others, particularly those with cervical spinal cord injuries, ask why not choose some function that can be done with the hands or arms as an outcome measure.

    First, loss of walking and leg function is something that both paraplegics and quadriplegics suffer from. Recovery of voluntary leg muscle strength, touch/pinprick sensation, and walking could happen if we achieved regeneration, growth, plasticity in both cervical and thoracic spinal cord injury. We cannot choose arm function because this is something that only cervical spinal injured subjects could recover; paraplegics already have arm function.

    Second, we obviously chose walking as one of the outcome measures because we believe that it is potentially something that patients treated with umbiical cord blood mononuclear cells and lithium may recover within a year after treatment. Walking is in fact one of the most common behaviors to recover in people who have even severe incomplete spinal cord injuries. For example, sensory incompletes (ASIA B) have a >25% chance of recovering unassisted walking within a year after injury. Motor incompletes have a >90% chance of recovering walking whereas ASIA A's have less than 5%. Our goal of the therapy is to make people with "complete" injuries incomplete, and people with incomplete injuries more incomplete.

    Third, walking sometimes will recover even more and faster than voluntary control of leg movements. For example, people with ASIA C spinal cord injury are able to walk but cannot voluntarily move their legs in other ways. This is because walking is governed by the central pattern generator (CPG) located at about L2 spinal cord. One only needs to excite the CPG with non-specific innervation to get unassisted walking whereas one may need more direct control of motoneurons to get the leg to kick a football voluntarily.

    We have seen this pattern occur with the walking recovery of patients in Kunming where walking recovery seemed to precede the recover of voluntary strength in the leg muscles after intradural decompression of the spinal cord of ASIA A subjects. Based on these results, we believe that walking may indeed one of the "low hanging fruits" of recovery. it is relatively easy to quantify and should be impressive if it does occur in people who are chronic ASIA A or B.

    Wise.

    #2
    Dr Young,

    Is it possible to post the picture you presented Friday night at the open house (or the entire presentation)?

    The specific slide I am referring to showed the various phases of the 6/6/6 walking therapy in Kumming.

    Thanks, Sharon

    Comment


      #3
      dr wise,
      i don't know how to start but here goes.
      im a c4/c5 asia c injury, and have walked on the locomat wen i was at shepherd centre.
      but i got some movement in my legs only by the end of my stay there.
      now that im back in india i have alot more movwment in my legs.
      i do stand using calipers and put my weight on a frame in front of me.
      im wondering if i should practise some form of locomotion, and if i should then how?
      kindly do help
      vaibhav jain

      Comment


        #4
        .

        We have seen this pattern occur with the walking recovery of patients in Kunming where walking recovery seemed to precede the recover of voluntary strength in the leg muscles after intradural decompression of the spinal cord of ASIA A subjects. Based on these results, we believe that walking may indeed one of the "low hanging fruits" of recovery. it is relatively easy to quantify and should be impressive if it does occur in people who are chronic ASIA A or B.

        Wise.[/QUOTE]

        Impressive? You would rock the SCI/medical research world. My only concern would be whether it would be hard to convince people that some of the higher hanging fruits are important to pick. But that would be a good problem to have.
        2012 SCINetUSA 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.

        Comment


          #5
          Originally posted by SharonD View Post
          Dr Young,

          Is it possible to post the picture you presented Friday night at the open house (or the entire presentation)?

          The specific slide I am referring to showed the various phases of the 6/6/6 walking therapy in Kumming.

          Thanks, Sharon
          Here it is.

          Comment


            #6
            Originally posted by vaibhavjain View Post
            dr wise,
            i don't know how to start but here goes.
            im a c4/c5 asia c injury, and have walked on the locomat wen i was at shepherd centre.
            but i got some movement in my legs only by the end of my stay there.
            now that im back in india i have alot more movwment in my legs.
            i do stand using calipers and put my weight on a frame in front of me.
            im wondering if i should practise some form of locomotion, and if i should then how?
            kindly do help
            vaibhav jain
            vailbhavjain, you need somebody experienced in locomotor training to help you. It is not something that can be described easily in words. Somebody has to look at you like a coach and help you get through the various stages of walking.

            Wise.

            Comment


              #7
              yes dr wise i do agree with you, my therapist is used to coaching patients for locomotion, i am asking if it is suggested for me, and in your opinion go back to shepherd?

              Comment


                #8
                Dr. Young. you've probably already said this recently, but can you tell us how much more money you need to complete these clinical trials?
                2012 SCINetUSA 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.

                Comment


                  #9
                  Dr. Young,

                  Forgive me if I've missed this, but when do you anticipate the outcome measure results using the mononuclear cells and lithium?

                  Comment


                    #10
                    ^ kthx.

                    f
                    ight

                    Comment


                      #11
                      schmeky. I think it is said somewhere that the patients will be evaluated 6 weeks and six months after the Treatment... Dunno if that helps
                      "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

                      Comment


                        #12
                        Originally posted by vaibhavjain View Post
                        yes dr wise i do agree with you, my therapist is used to coaching patients for locomotion, i am asking if it is suggested for me, and in your opinion go back to shepherd?
                        Yes, I believe that locomotor training is good, not only for walking but for health. Shepard is a great rehabilitation center. Wise

                        Comment


                          #13
                          Originally posted by Schmeky View Post
                          Dr. Young,

                          Forgive me if I've missed this, but when do you anticipate the outcome measure results using the mononuclear cells and lithium?
                          We are still recruiting patients and optimizing the cells. The 6 month results will be at least a year away for the phase 2. Wise

                          Comment


                            #14
                            Originally posted by swh2007 View Post
                            Dr. Young. you've probably already said this recently, but can you tell us how much more money you need to complete these clinical trials?
                            The current phase 2 ChinaSCINet trial in Hong Kong will cost about US$400,000. We have raised that amount. The phase 3 trial in ChinaSCINet will require about $8 million. We have not raised that amount yet.

                            The planned phase 2 SCINetUSA trial in Austin will cost about US$2 million and we have begun to raise that with the Lone Star Foundation in Austin. The phase 3 trial involving 240 subjects will cost about $24 million.

                            These costs do not include the costs of the cells and processing, donated by Stemcyte for the trials.

                            Comment


                              #15
                              Well, when you need recruits I don't think you'll have to look far. I could be ready tomorrow

                              Comment

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