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Thread: Miami Project

  1. #11
    Personally I think he work Wise is doing in ChinaSCINet will reach the clinic quicker but how do I know? I have faith in Wise.........

  2. #12
    This is good news that the application is in.
    "Life is about how you
    respond to not only the
    challenges you're dealt but
    the challenges you seek...If
    you have no goals, no
    mountains to climb, your
    soul dies".~Liz Fordred

  3. #13
    The Miami Project is happy to tell you that we have submitted our application to the FDA to request permission to start a phase 1 clinical trial to test the safety of injecting Schwann cells into people with SCI. We now have to wait for a response from the FDA.

    This first trial is purely testing safety, because we have to do surgery on people and actually stick a needle into their spinal cord injury site in order to put their Schwann cells inside. It will only involve about 8 people and they will all be new injuries. The main reason we are doing new injuries first is because we have more animal data in that setting and it allows us to get FDA approval faster. Getting faster FDA approval means going into people faster, which means finding out about safety faster. As soon as we know it is safe to inject, we can then start additional trials expanding into chronic injuries, incomplete injuries, and even combination therapies (which will likely be much more effective at restoring function to people than just Schwann cells by themselves – or anything by itself for that matter).

    So think of this as our building block to developing the most effective treatments for people living with SCI. The best way to get access to these treatments fastest is to keep yourself healthy and in very good condition so that you qualify for clinical trials as they become available and for which you qualify. For treatments to go all the way through multiple clinical trials and become mainstream medical practice in the “clinic” could take 10-15 years or more depending on the intervention. But participating in clinical trials not only helps us get there faster, but also benefits the clinical trial participants faster than the rest of the public.


  4. #14
    Finally good news from MP, but I think their timeframes are a little out of reality,
    For treatments to go all the way through multiple clinical trials and become mainstream medical practice in the “clinic” could take 10-15 years or more depending on the intervention.
    -Ramps in buildings are necessary, but it would be usefull to have another ones for people (mind/heart).....

    -Hoc non pereo habebo fortior me

  5. #15
    Senior Member lynnifer's Avatar
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    Actually I thought those were quite accurate timelines - do you think they're too much or too less?
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  6. #16
    Quote Originally Posted by lynnifer View Post
    Actually I thought those were quite accurate timelines - do you think they're too much or too less?
    For only trials is too much time. How many years will spend Dr.Young for example?

    Obviously if you take the whole research with initial paperwork, animal studies, human trials,.... could be even more time.
    -Ramps in buildings are necessary, but it would be usefull to have another ones for people (mind/heart).....

    -Hoc non pereo habebo fortior me

  7. #17
    Quote Originally Posted by Isildur View Post
    For only trials is too much time. How many years will spend Dr.Young for example?

    Obviously if you take the whole research with initial paperwork, animal studies, human trials,.... could be even more time.
    im with you on this. in a video of wise young he has stated that he thinks its possible to see people walking within 3 years. obviously thats if everything went as planned. which already seems like its been slowed down some. (HK trial).

  8. #18
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    Quote Originally Posted by Barrington314mx View Post
    im with you on this. in a video of wise young he has stated that he thinks its possible to see people walking within 3 years. obviously thats if everything went as planned. which already seems like its been slowed down some. (HK trial).
    Phase1, 2 and 3 clinical trials to be complete can take that long (10 to 15 yrs.) before it's available to the general public

    That Miami Project press release pisses me off...20 years+/- of work and they are just submitting to the FDA? They don't have much animal data on chronic's so they are starting with Acutes? No combination therapy animal data?

    WHAT THE HELL HAVE THEY BEEN DOING ALL THIS TIME????

    I'VE EMAILED THEM 3 TIMES TO GET ANSWERS AND NOT ONE WAS EVER RETURNED

  9. #19
    Was this an actual press release? I know I'm nit-picking, but it's casual to the point of being insulting.

    Quote Originally Posted by Barrington314mx View Post
    The Miami Project is happy to tell you that we have submitted our application to the FDA to request permission to start a phase 1 clinical trial to test the safety of injecting Schwann cells into people with SCI. We now have to wait for a response from the FDA.

    This first trial is purely testing safety, because we have to do surgery on people and actually stick a needle into their spinal cord injury site in order to put their Schwann cells inside. It will only involve about 8 people and they will all be new injuries. The main reason we are doing new injuries first is because we have more animal data in that setting and it allows us to get FDA approval faster. Getting faster FDA approval means going into people faster, which means finding out about safety faster. As soon as we know it is safe to inject, we can then start additional trials expanding into chronic injuries, incomplete injuries, and even combination therapies (which will likely be much more effective at restoring function to people than just Schwann cells by themselves – or anything by itself for that matter).

    So think of this as our building block to developing the most effective treatments for people living with SCI. The best way to get access to these treatments fastest is to keep yourself healthy and in very good condition so that you qualify for clinical trials as they become available and for which you qualify. For treatments to go all the way through multiple clinical trials and become mainstream medical practice in the “clinic” could take 10-15 years or more depending on the intervention. But participating in clinical trials not only helps us get there faster, but also benefits the clinical trial participants faster than the rest of the public.

    Any results they identify on acutes will be hopelessly muddled.

  10. #20
    Quote Originally Posted by Scaper1 View Post
    Was this an actual press release? I know I'm nit-picking, but it's casual to the point of being insulting.



    Any results they identify on acutes will be hopelessly muddled.
    it was an email i just recieved.

    this is on their website...

    http://www.miamiproject.miami.edu/

    The Miami Project to Cure Paralysis, at the University of Miami Miller School of Medicine has submitted today its first Investigational New Drug (IND) application to the Food and Drug Administration (FDA) requesting permission to begin a Phase I clinical trial to evaluate the safety of autologous human Schwann cell transplantation in the subacute spinal cord injury (SCI) setting.

    The clinical protocol of the Phase I trial is strictly focused on safety outcomes. Therefore, the proposed clinical trial is designed to enroll 8 participants with complete thoracic SCI. Newly injured patients would have to meet the stringent inclusion/exclusion criteria and agree to participate in further screening within 5 days after their injury, which is considered the acute phase. At that point, the participant will have a biopsy of a sensory nerve in one leg to obtain his or her own Schwann cells. The Schwann cells will then need to grow in a culturing facility for 3 to 5 weeks to generate the number of cells necessary for transplantation, and to undergo the strict purification process. By the time the Schwann cells are transplanted into the site of spinal cord injury, the participant will be 26-40 days post-injury, which is considered the sub-acute phase.

    Led by W. Dalton Dietrich, Ph.D., Scientific Director, The Miami Project to Cure Paralysis, the Schwann cell clinical trial team is comprised of a multi-disciplinary group of faculty level scientists, neurosurgeons, and staff focused on advancing the trial.

    Read more

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