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    How To Enroll In Wise Young's Trials

    What is the enrollment process? I assume it is done by 3rd party and not Wise. I read Dr. Wise Young saying the most important criteria is someone that will follow thru with coming back for check ups like the 6 mnth one.

    How do you determine that? Can you even or is it random and you just hope? I am sure there are plenty of good candidates but as a former athlete and someone who has worked hard since the accident and is used to physical training and enjoys it. I know I'd be pretty ideal.

    When will the entollments likely start for Texas and is it possible to become enrolled for phase 3 in China???

    #2
    Originally posted by Lyerly View Post
    What is the enrollment process? I assume it is done by 3rd party and not Wise. I read Dr. Wise Young saying the most important criteria is someone that will follow thru with coming back for check ups like the 6 mnth one.

    How do you determine that? Can you even or is it random and you just hope? I am sure there are plenty of good candidates but as a former athlete and someone who has worked hard since the accident and is used to physical training and enjoys it. I know I'd be pretty ideal.

    When will the entollments likely start for Texas and is it possible to become enrolled for phase 3 in China???
    The decisions concerning who enters in clinical trials are made by investigators of each center. Subjects must fulfill the inclusion and exclusion criteria. Since the trials are still being discussed and none of the trial centers have been definitively selected, it is too early to be trying to get into one or another trial center. As soon as this information is available, we will post this on http://clinicaltrials.gov and also here on carecure.org

    Regarding eligibility of people to enter the China trials, much depends on the funding that we obtain for the trials. For obvious reasons, if the funding is only for Chinese citizens, it would be difficult to enter the person into a trial. This was a problem, for example, in Hong Kong where the people entering the phase 2 trials must be Hong Kong residents.

    Wise.

    Comment


      #3
      Originally posted by Wise Young View Post

      Regarding eligibility of people to enter the China trials, much depends on the funding that we obtain for the trials. For obvious reasons, if the funding is only for Chinese citizens, it would be difficult to enter the person into a trial. This was a problem, for example, in Hong Kong where the people entering the phase 2 trials must be Hong Kong residents.

      Wise.
      what if the patient could arrange the funds themself ahead of time?

      Comment


        #4
        Originally posted by Barrington314mx View Post
        what if the patient could arrange the funds themself ahead of time?
        Barrington, that is not allowed for clinical trials. I know that many people pay for experimental therapies in medical tourism clinics. Clinical trials are not supposed to charge patients for experimental therapies. That is what separates medical tourism from clinical trials. If approved by appropriate regulatory approvals, a clinical trial may allow a subject to pay for therapies that have known benefits (such as rehabilitation and locomotor training) but not for the experimental therapy (which is the umbilical cord blood and lithium therapy).

        Wise.

        Comment


          #5
          didnt you talk about a person that had bought their own cells, and were paying docs to do the surgery and it was essentially a trial of 1 person? i thought i heard you mention something like that in maybe the april or may open house video.

          Comment


            #6
            Originally posted by Wise Young View Post
            The decisions concerning who enters in clinical trials are made by investigators of each center. Subjects must fulfill the inclusion and exclusion criteria. Since the trials are still being discussed and none of the trial centers have been definitively selected, it is too early to be trying to get into one or another trial center. As soon as this information is available, we will post this on http://clinicaltrials.gov and also here on carecure.org

            Regarding eligibility of people to enter the China trials, much depends on the funding that we obtain for the trials. For obvious reasons, if the funding is only for Chinese citizens, it would be difficult to enter the person into a trial. This was a problem, for example, in Hong Kong where the people entering the phase 2 trials must be Hong Kong residents.

            Wise.
            I remember reading the biggest concerns were to have people that would return to the 6mnth checkup and any others. How can this be determined is it something where if you meet the inclusion criteria you interview about or something?

            I for one am 3.5 yrs post and after about a year of bed rest I have been working and doing what I can do get stuff back. From standing daily to using Lokomat 3 days a week and doing a few hours of other activity like you would do at Project Walk or Beyond Therapy.

            Is it classification from the beginning? I was T10/11 Asia A and a year and two year later I am T12 Asia C. Also I think T11 was as low as this trial was going so even though I function as T12 Asia C would my injury still be considered T10/11 and could be included in it?

            I am sure there are many people who like myself feel they would be ideal candidates. I am a former college athlete and have done about all I can to maintain and improve from my accident.

            Can not that you enough for what you are trying to do.

            Comment


              #7
              i doubt that they may be westerners in the study, he did say that it was a problem to recruit locals who either drop out or dis continue for many reasons.
              no CCC member i know of is involved.
              Again many may see the study as a long shot at a cure, entering with sole expectation of gaining efficacy of some sort

              Comment


                #8
                Originally posted by Barrington314mx View Post
                didnt you talk about a person that had bought their own cells, and were paying docs to do the surgery and it was essentially a trial of 1 person? i thought i heard you mention something like that in maybe the april or may open house video.
                Yes, there was a person who had made his own IPS (induced pluripotent stem cells) and wanted us to transplant the cells into him. We held a meeting to listen to his scientific team and the data. We thought that it was not yet ready and asked for more data.

                Wise.

                Comment


                  #9
                  Originally posted by Lyerly View Post
                  I remember reading the biggest concerns were to have people that would return to the 6mnth checkup and any others. How can this be determined is it something where if you meet the inclusion criteria you interview about or something?

                  I for one am 3.5 yrs post and after about a year of bed rest I have been working and doing what I can do get stuff back. From standing daily to using Lokomat 3 days a week and doing a few hours of other activity like you would do at Project Walk or Beyond Therapy.

                  Is it classification from the beginning? I was T10/11 Asia A and a year and two year later I am T12 Asia C. Also I think T11 was as low as this trial was going so even though I function as T12 Asia C would my injury still be considered T10/11 and could be included in it?

                  I am sure there are many people who like myself feel they would be ideal candidates. I am a former college athlete and have done about all I can to maintain and improve from my accident.

                  Can not that you enough for what you are trying to do.
                  In Hong Kong, the cost of the trials was partly supported by the government and the trials were intended only for people who are Hong Kong residents. In addition to the inclusion and exclusion criteria, we ask the investigators to excluded candidates who are unlikely to come back for followup exams. As I explained earlier, if a person does not come back for followup, this really messes up our trials. We are investing a huge amount into each subject and, if that subject doesn't come back for followup, this would be a big loss for us.

                  The classification and neurological level required for inclusion is at the time of the screening examination for the trial. Neurological level is defined as the lowest contiguous level with intact motor and sensory function. So, if you are T12, you would not fit the eligibility criterion for the trial.

                  Wise.

                  Comment


                    #10
                    I have been wondering what individual costs would be to get into trials.

                    Comment


                      #11
                      Originally posted by jody View Post
                      I have been wondering what individual costs would be to get into trials.
                      Nobody should pay for offering his/her body for experiment
                      not only did i not pay a single cent, but accomodation, flights meals taxi service for me and my care giver where paid by stem cell inc and this was only for a screening test.
                      Last edited by peterf; 28 Jun 2012, 3:33 PM.

                      Comment


                        #12
                        Originally posted by Wise Young View Post
                        In Hong Kong, the cost of the trials was partly supported by the government and the trials were intended only for people who are Hong Kong residents. In addition to the inclusion and exclusion criteria, we ask the investigators to excluded candidates who are unlikely to come back for followup exams. As I explained earlier, if a person does not come back for followup, this really messes up our trials. We are investing a huge amount into each subject and, if that subject doesn't come back for followup, this would be a big loss for us.

                        The classification and neurological level required for inclusion is at the time of the screening examination for the trial. Neurological level is defined as the lowest contiguous level with intact motor and sensory function. So, if you are T12, you would not fit the eligibility criterion for the trial.

                        Wise.
                        Isn't people at levels in the low Ts mixed with lower and upper motor neuron? I have flaccid leg muscles but a crazy spastic bladder. Gonna be pretty tough to handle if your therapy shows promising results and you can be to low to use it and see benefit.

                        Comment


                          #13
                          Originally posted by Lyerly View Post
                          Isn't people at levels in the low Ts mixed with lower and upper motor neuron? I have flaccid leg muscles but a crazy spastic bladder. Gonna be pretty tough to handle if your therapy shows promising results and you can be to low to use it and see benefit.
                          Lyerly, that is correct. The lumbar cord begins around vertebral segment T10 and extends to vertebral T12. The sacral cord is at vertebral level L1. So, if your neurological level is T11 (i.e. T11 is intact), this means that your injury is affecting T12 spinal cord and below.

                          We are aiming for lumbosacral spinal cord injury in our 2014 trials, i.e. people who have injuries to their T11. We are starting the animal experiments now to develop a model of lumbosacral spinal cord injury and we are testing cell transplants, lithium, and axonal growth inhibitor blockers (Cethrin and possibly others).

                          Wise.

                          Comment


                            #14
                            Jody,

                            A legitimate clinical trial should not be charging patients for experimental therapies. The US FDA has changed the rules somewhat to allow clinical trials to charge for therapies that have proven value in clinical trials but not for the experimental therapy. However, any charges must be approved by the U.S. FDA as well as the institutional review boards. For example, we might be able to make the argument that locomotor training is beneficial and ask the patients to pay for that portion of the trial but not for the experimental part, which is the umbilical cord blood cell transplant and lithium.

                            The other possibility is for us to design the clinical trial around patients who need surgery for some reason, i.e. syringomyelia, and then transplant the cells while the spinal cord is exposed. That was what Ed Wirth and his colleagues did at University of Florida in Gainesville about a decade ago when they were injecting fetal spinal cord tissues into the spinal cord. Since the surgery for syringomyelia is required, one can charge for that and the addition of cell transplants would be a freebie.

                            Another example is what Lisa McKerracher and Bioaxone did with Cethrin. They had the surgeon apply the Cethrin to the dural surface of patients who were getting laminectomy to expose the spinal cord after trauma. This essentially reduced the cost of the clinical trial to the cost of the drug and the examination of the patients. However, since the laminectomies were done in the first week after injury, the treatment was given only during the subacute phase of spinal cord injury.

                            In our case, however, since we are planning to do the surgery on chronic spinal cord injury, we must pay for the surgery. We are also planning to provide intensive locomotor training for at least 6 weeks. Together the cost of the surgery and the rehabilitation will add up to about $100,000 or more in the United States. That is what makes a chronic spinal cord injury trial much more expensive than an acute spinal cord injury trial.

                            Wise.

                            Comment


                              #15
                              Originally posted by Wise Young View Post
                              Lyerly, that is correct. The lumbar cord begins around vertebral segment T10 and extends to vertebral T12. The sacral cord is at vertebral level L1. So, if your neurological level is T11 (i.e. T11 is intact), this means that your injury is affecting T12 spinal cord and below.

                              We are aiming for lumbosacral spinal cord injury in our 2014 trials, i.e. people who have injuries to their T11. We are starting the animal experiments now to develop a model of lumbosacral spinal cord injury and we are testing cell transplants, lithium, and axonal growth inhibitor blockers (Cethrin and possibly others).

                              Wise.
                              You are still including as low as T11 as far as I remember?

                              Comment

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