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    Dr Young - when it's time to test a cure

    Greetings Dr. Young and thank you for your work. We got into a conversation this weekend about clinical trials and wondered who might be eligible to participate. We have two friends who have a sustained a SCI....

    Friend #1 is a vent dependent C1-C2, Asia A, 25+ years post. He's in his 40's. As this point in his life, he thinks he has very little to lose and wants to be considered. In his words, there isn't much to lose. He has very little sensation below his injury and the patches he has are not normal. He has no movement below his injury. For him, recovery of a couple of levels that would enable him to be vent free and perhaps have some arm / hand movement would be significant.

    Friend #2 is a C5-C6, Asia B, 4 years post. He's in his early 20's. He has very little bicep function (cannot lift his hand to his face) but has very good, almost normal sensation below his injury. While he would love to have arms and hands, he wants much more, including B and B and walking. He wants to have a pre-injury body.

    So, when you are looking at clinical trials, do you take the older injury and older person Asia A with little to lose or do you take a younger, more recent injury with more to lose in your trials? And what about the Asia C's and D's, the walkers? Obviously restoring an Asia A of 25 years would be amazing; restoring an Asia B to an Asia C or D is also significant, especially for quads like our friend who requires significant assistance in daily care; the walkers could potentially be "cured", using your cure description.

    As the China trials begin, we're just curious to know the profile that will be considered, both abroad and here. I'm trying to be optimistic and hope that a cure (or a partial cure) is going to happen in the next few years.

    I'd appreciate hearing your thoughts. I value and appreciate your hard work.

    #2
    Hi beach,

    For the ChinaSCINet trials:

    The age range is 18-70.
    People with neuropathic pain will not be excluded.
    The cut off for the highest injury accepted is C5.

    Comment


      #3
      beachlover,

      Let me first start by saying that a lot of details of the clinical trials to come in ChinaSCINet are not set in stone.

      However, we are very likely to restrict the trials to an age range of perhaps 18-65 and C4 to T10. There is a debate going on right now whether we can afford to carry out a clinical trial of both complete and incomplete injuries. I believe that we should do both but this would double the number of subjects that we have to test for the trial.

      The reason that we need to restrict the range of ages and injury levels is to increase the consistency of the data collected so that we don't have to study as many subjects in order to get a statistically effect. In China, few of the facilities have facilities for ventilator dependent patients.

      What I would like to do is to set up clinical trials in the United States, as well as smaller clinical trials aimed directly at high cervical spinal cord injury.

      Wise.


      Originally posted by beachlover
      Greetings Dr. Young and thank you for your work. We got into a conversation this weekend about clinical trials and wondered who might be eligible to participate. We have two friends who have a sustained a SCI....

      Friend #1 is a vent dependent C1-C2, Asia A, 25+ years post. He's in his 40's. As this point in his life, he thinks he has very little to lose and wants to be considered. In his words, there isn't much to lose. He has very little sensation below his injury and the patches he has are not normal. He has no movement below his injury. For him, recovery of a couple of levels that would enable him to be vent free and perhaps have some arm / hand movement would be significant.

      Friend #2 is a C5-C6, Asia B, 4 years post. He's in his early 20's. He has very little bicep function (cannot lift his hand to his face) but has very good, almost normal sensation below his injury. While he would love to have arms and hands, he wants much more, including B and B and walking. He wants to have a pre-injury body.

      So, when you are looking at clinical trials, do you take the older injury and older person Asia A with little to lose or do you take a younger, more recent injury with more to lose in your trials? And what about the Asia C's and D's, the walkers? Obviously restoring an Asia A of 25 years would be amazing; restoring an Asia B to an Asia C or D is also significant, especially for quads like our friend who requires significant assistance in daily care; the walkers could potentially be "cured", using your cure description.

      As the China trials begin, we're just curious to know the profile that will be considered, both abroad and here. I'm trying to be optimistic and hope that a cure (or a partial cure) is going to happen in the next few years.

      I'd appreciate hearing your thoughts. I value and appreciate your hard work.

      Comment


        #4
        Originally posted by Wise Young
        beachlover,

        Let me first start by saying that a lot of details of the clinical trials to come in ChinaSCINet are not set in stone.

        However, we are very likely to restrict the trials to an age range of perhaps 18-65 and C4 to T10. There is a debate going on right now whether we can afford to carry out a clinical trial of both complete and incomplete injuries. I believe that we should do both but this would double the number of subjects that we have to test for the trial.

        The reason that we need to restrict the range of ages and injury levels is to increase the consistency of the data collected so that we don't have to study as many subjects in order to get a statistically effect. In China, few of the facilities have facilities for ventilator dependent patients.

        What I would like to do is to set up clinical trials in the United States, as well as smaller clinical trials aimed directly at high cervical spinal cord injury.

        Wise.
        Dr. Young, to start clinical trials in the United States, home sweet home is a splendent idea! Imaging the publicity, the results of the trial, you will make history. What a hope you'll going to give to the whole world. Please tell us how can we help you to succeed. I know you will say money but is more than that, right Dr. Young?

        manouli.
        Last edited by manouli; 8 Aug 2007, 2:13 PM.

        Comment


          #5
          Thanks for the update Wise. Thought I read 18-70 somewhere. The other info. was pulled from these posts:

          At least for the time being, we have a cutoff of the highest injury site being at C5. The reason is because we really don't want to do a laminectomy at C2 and inject the cells so close to the phrenic nucleus located at C3. With a fusion from C3-C7, I assume that you have an injury level of C5. I assume that your fusion is anterior. If so, this should ot interfere with the laminectomy. We will be relying on our surgeons to decide whether or not the surgery is feasible.
          /forum/showpost.php?p=691537&postcount=2

          Inclusion/exclusion criteria:

          /forum/showpost.php?p=631583&postcount=1
          Last edited by antiquity; 8 Aug 2007, 3:10 PM.

          Comment


            #6
            Manouli seems right on. What can I do to hurry those up?

            Also, any mutual funds or stocksto "invest" in? IF they're successful it would be investment, but otherwise it would at least be a contribution for a good cause.

            Scott.

            Comment


              #7
              Dr. Wise, do u see any possibility in india for the ChinaSCINEt stem cell trials? What i need to participate?
              ChemistOnline.in

              Comment


                #8
                Originally posted by Shwetarose
                Dr. Wise, do u see any possibility in india for the ChinaSCINEt stem cell trials? What i need to participate?
                shwetarose, I have been talking with neurosurgeons in India. There is definite interest in India. Wise.

                Comment


                  #9
                  Originally posted by Scott Buxton
                  Manouli seems right on. What can I do to hurry those up?

                  Also, any mutual funds or stocksto "invest" in? IF they're successful it would be investment, but otherwise it would at least be a contribution for a good cause.

                  Scott.
                  Scott,

                  At some time perhaps we can talk about the possibility of creating a mutual fund that invests in stocks of companies that are sponsoring spinal cord injury clinical trials.

                  Wise.

                  Comment


                    #10
                    Originally posted by antiquity
                    Thanks for the update Wise. Thought I read 18-70 somewhere. The other info. was pulled from these posts:



                    /forum/showpost.php?p=691537&postcount=2

                    Inclusion/exclusion criteria:

                    /forum/showpost.php?p=631583&postcount=1
                    Antiquity, I want to emphasize that a lot of these are proposed criteria. The criteria are not set until the trials are approved. Wise.

                    Comment


                      #11
                      Originally posted by Wise Young
                      Scott,

                      At some time perhaps we can talk about the possibility of creating a mutual fund that invests in stocks of companies that are sponsoring spinal cord injury clinical trials.

                      Wise.
                      I would be VERY interested in investing!
                      And the truth shall set you free.

                      Comment


                        #12
                        Originally posted by Wise Young

                        What I would like to do is to set up clinical trials in the United States, as well as smaller clinical trials aimed directly at high cervical spinal cord injury.

                        Wise.
                        Wise,

                        Please forgive my ignorance, I've read some of the language in THE CHRISTOPHER AND DANA REEVE PARALYSIS ACT and what I am wondering is if I could accurately state that this bill would directly help you and other scientists involved with clinical trials in the United States.

                        It appears that one and one make two, but I don't want to assume anything when writing to paralysis organizations for support. I know this question is *Overly* redundant but, I want to make sure I get my facts straight.

                        many thanks for your hard work,

                        Comment


                          #13
                          Originally posted by Chaz19
                          Wise,

                          Please forgive my ignorance, I've read some of the language in THE CHRISTOPHER AND DANA REEVE PARALYSIS ACT and what I am wondering is if I could accurately state that this bill would directly help you and other scientists involved with clinical trials in the United States.

                          It appears that one and one make two, but I don't want to assume anything when writing to paralysis organizations for support. I know this question is *Overly* redundant but, I want to make sure I get my facts straight.

                          many thanks for your hard work,
                          Chaz,

                          I attach the actual bill for everybody to look at. It has been extensively revised. As I read it, it gives the NIH a great deal of latitude regarding how they will plan, coordinate, and implement this program. The first section will focus on basic, translational, and clinical pralaysis research. The second section will be for rehabilitation and care. The third section will be devoted to improving quality of life. The bill allocates $25 million per year for 2008 through 2011.

                          It is not a lot of money. Split three ways research, rehabilitation, and quality of life research, this means perhaps $6-7 million per year for each. I think that the Director of NIH will have some latitude regarding how the money would be split. If and when the bill passes, people can write to the Director of NIH to ask for emphasis of one or another part of the bill. The bill stipulates the need to get community feedback.

                          Yes, I think that it will help the field a great deal. For example, just $6 million a year for more spinal cord injury grants would result in 20 or more additional grants for spinal cord injury grants per year. It may help fund a clinical trial network. The community, however, will need to keep putting people's feet to the fire and get them to invest correctly into high priority projects for the community.

                          Wise.

                          Comment


                            #14
                            Originally posted by Wise Young
                            shwetarose, I have been talking with neurosurgeons in India. There is definite interest in India. Wise.
                            Clinical trials in China and India. These are 2 of the most populous countries. That would be great.

                            Is this a real possibility Dr. Young?

                            Comment


                              #15
                              Originally posted by Schmeky
                              Clinical trials in China and India. These are 2 of the most populous countries. That would be great.

                              Is this a real possibility Dr. Young?
                              the more subjects involved in a trial .......the better results.

                              Comment

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