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Thread: How To Enroll In Wise Young's Trials

  1. #1

    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. #2
    Quote 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.

  3. #3
    Quote 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?

  4. #4
    Quote 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.

  5. #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.

  6. #6
    Quote 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.

  7. #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

  8. #8
    Quote 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.

  9. #9
    Quote 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.

  10. #10
    Moderator jody's Avatar
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    I have been wondering what individual costs would be to get into trials.

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