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  • Miami project opens recruitment for chronic SCI

    https://clinicaltrials.gov/ct2/show/...injury&rank=15
    "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

  • #2
    to anybody that can help me with a question that I have always had about this ....for this safety phase, they harvest a sural nerve from the leg, isolate the relevant cells (schwann cells ) then inject them into the injury site and couple with rehab. Ok, so what will be different between this safety phase and the efficacy phase? What else to add?
    "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

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    • #3
      Originally posted by lunasicc42 View Post
      to anybody that can help me with a question that I have always had about this ....for this safety phase, they harvest a sural nerve from the leg, isolate the relevant cells (schwann cells ) then inject them into the injury site and couple with rehab. Ok, so what will be different between this safety phase and the efficacy phase? What else to add?
      Could be more cells, could be more rehab, or both. When doing a safety trial, they mainly want to give the smallest dosage they can just to show the surgery and the cells are safe. After that, once it has been shown to be safe, they can get more aggressive and give a higher number of cells and/or more physical training, if thats the direction they decide to go.

      They also say that subjects' SCI must be a minimum of 12 months old, which I think most people would classify as sub-acute, not chronic. This requirement does leave it open for some chronics to be entered though, which is good.

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      • #4
        Originally posted by tomsonite View Post
        Could be more cells, could be more rehab, or both. When doing a safety trial, they mainly want to give the smallest dosage they can just to show the surgery and the cells are safe. After that, once it has been shown to be safe, they can get more aggressive and give a higher number of cells and/or more physical training, if thats the direction they decide to go.

        They also say that subjects' SCI must be a minimum of 12 months old, which I think most people would classify as sub-acute, not chronic. This requirement does leave it open for some chronics to be entered though, which is good.
        A minimum of 12 months would be exclusively chronic.

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        • #5
          Originally posted by nrf View Post
          A minimum of 12 months would be exclusively chronic.
          Yeah tomsonite, you accidentally had that backwards
          "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

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          • #6
            Originally posted by lunasicc42 View Post
            Yeah tomsonite, you accidentally had that backwards
            Yeah!

            ...wait let me get my pitchfork...

            YEEAHHH!!!!

            lol sorry I got real happy, then sad, and now sort of happy that it could be open to chronics...

            Regards

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            • #7
              What is so special about Schwan cells again? And would the Miami project be the most heavily funded SCI research organization in the US?

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              • #8
                Originally posted by lunasicc42 View Post
                to anybody that can help me with a question that I have always had about this ....for this safety phase, they harvest a sural nerve from the leg, isolate the relevant cells (schwann cells ) then inject them into the injury site and couple with rehab. Ok, so what will be different between this safety phase and the efficacy phase? What else to add?
                I know you've been waiting for a long time for this trial to happen. I hope it goes well. For humans with chronic SCI, they hypothesize that axons might show improved function if myelin repair is induced with the implantation of ahSC. In addition spinal cord cavitation may be reduced, and neural sprouting and plasticity may be enhanced via neurotrophic effects. It may be that these particular cells would need to be added into certain combo therapies in the future depending on the particular type of SCI injury.
                Let's hope they perform well in people!
                Last edited by GRAMMY; 02-13-2015, 01:47 AM. Reason: spelling
                http://spinalcordresearchandadvocacy.wordpress.com/

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                • #9
                  Originally posted by JamesMcM View Post
                  What is so special about Schwan cells again? And would the Miami project be the most heavily funded SCI research organization in the US?
                  Read: http://www.themiamiproject.org/page.aspx?pid=861
                  Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.

                  T-11 Flaccid Paraplegic due to TM July 1985 @ age 12

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                  • #10
                    I wonder why they are only using 2 people for the trial?

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                    • #11
                      Trial enrollment will target 2 cohorts. The first cohort will be thoracic (T) level 2-12 ASIA Impairment Scale (AIS) grade A, B, or C (n = up to 4), the second cohort will be cervical (C) level 5 through T1 AIS A, B, or C (n = up to 6). Two (2) participants with AIS grade A will be enrolled prior to enrolling a participant with AIS B or C, applicable to both cohorts.

                      By cohorts they mean groups. The ASIA A group will be 2 participants, other group, up to 8.

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                      • #12
                        Originally posted by lynnifer View Post
                        Very interesting, thanks! I always thought Schwann cells were discovered by the Miami project, and patented as well.

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                        • #13
                          Originally posted by GRAMMY View Post
                          I know you've been waiting for a long time for this trial to happen. I hope it goes well. For humans with chronic SCI, they hypothesize that axons might show improved function if myelin repair is induced with the implantation of ahSC. In addition spinal cord cavitation may be reduced, and neural sprouting and plasticity may be enhanced via neurotrophic effects. It may be that these particular cells would need to be added into certain combo therapies in the future depending on the particular type of SCI injury.
                          Let's hope they perform well in people!
                          Yes ,thank you.I have been waiting for this but a question has been bugging me that maybe you can answer...I was under the impression that a group in Iran already tried this same method with not-so-stellar results. Do you know what will be different with this trial? That always worried me.
                          "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

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                          • #14
                            Originally posted by lynnifer View Post
                            They mention axon regeneration 3 times in 9 bullet points. I don't believe them, disingenuous. They probably saw the tiniest distance of growth in the tiniest amount of axons.

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                            • #15
                              Is anyone from here going to try and get involved in this trial?

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