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Stemcyte Receives Phase II Investigational New Drug IND Clearance From The FDA

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  • Stemcyte Receives Phase II Investigational New Drug IND Clearance From The FDA

    https://www.prnewswire.com/news-rele...IziBOXnIde5CP0
    "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
    I must say that I am a supporter of Wise Young and Scinetusa... But I always thought that starting SCINETUSA was like putting the cart before the horse, where is the published data to pursue this trial... Not saying that I am not bigly excited and havent been waiting for this... Just saying that I would be 100% more confident going into this with more data or ideally before/after videos of the trial patients... Is that or something like that coming?
    Last edited by lunasicc42; 01-03-2019, 07:57 PM. Reason: eat my balls
    "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
      Luna, I have posted the paper several times. 75% of the subjects (ASIA A chronics from 2 to 20 years) recovered walking at Kunming level 4 or better, 60% regained bowel/bladder function. No difference was seen in length of time injured and recovery.

      The upcoming trial is summarized by Wise.
      Attached Files
      Last edited by Jim; 01-03-2019, 09:31 PM. Reason: added

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      • #4
        will there be videos of the patients or other media?
        "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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        • #5
          Congratulations for this achievement!!

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          • #6
            so, can you venture a rough idea or guesstimate as to when the US sites will start recruitment... A month?... A couple months... Less? More?
            "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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            • #7
              I would guess within 2 months.

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              • #8
                Originally posted by Jim View Post
                I would guess within 2 months.

                Heres to hoping success on that... I just wanna finally be part of something directly related to the effort
                "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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                • #9
                  Fantastic news, Jim. Congratulations and please extend my congrats to Wise, Patricia, and the rest of the team.

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                  • #10
                    This rehabilitation facility more then likely would be interested in working with the walking therapy phase of this clinical trial. They work closely with the Tampa Veteran's hospital. It would be worth contacting them. https://stayinstep.org

                    Anthony if you know where the link above should go to get to the right people send it to them. I would think Stay in Step would like to get involved.
                    Cindy Waters
                    mom to Anthony, right c5, left c4 (24yo)
                    injury march 2003

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                    • #11
                      Originally posted by waters3 View Post
                      This rehabilitation facility more then likely would be interested in working with the walking therapy phase of this clinical trial. They work closely with the Tampa Veteran's hospital. It would be worth contacting them. https://stayinstep.org

                      Anthony if you know where the link above should go to get to the right people send it to them. I would think Stay in Step would like to get involved.
                      Will do
                      "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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                      • #12
                        Originally posted by Jim View Post
                        Luna, I have posted the paper several times. 75% of the subjects (ASIA A chronics from 2 to 20 years) recovered walking at Kunming level 4 or better, 60% regained bowel/bladder function. No difference was seen in length of time injured and recovery.

                        The upcoming trial is summarized by Wise.
                        Hi Jim and thanks for the update..

                        World-wide Approval in 2021. We then will start Phase III trials to provide market approval in the United States, Europe, India, and China. The goal is to obtain world-wide regulatory approval for the first therapy that restores walking in people with chronic spinal cord injury. Not only will this enable insurance coverage, but it is the only way to dispel the pessimism and skepticism that has dominated the field and achieve consensus that there are safe and effective regenerative therapies to restore meaningful function in people with chronic severe spinal cord injury.
                        Do you know something about Europe ?..
                        I'm traveling between Spain, France and Belgium, if I can help don't hesitate to contact me.
                        Best wishes
                        George

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