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StemCells completes dosing of first cohort in cervical spinal cord injury study

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  • StemCells completes dosing of first cohort in cervical spinal cord injury study

    1. StemCells (STEM -3.2%) has completed transplanting the six patients comprising the first cohort in the Phase 2 Pathway Study. The objective in the open-label dose escalation arm is to determine the optimum dose to be used in the second cohort, a single-blind arm of 40 patients that will assess the efficacy of the company's HuCNS-SC (purified human neural stem cells) platform technology for the treatment of cervical spinal cord injury.
    2. The primary efficacy endpoint will focus on the change in upper body extremity strength (hands, arms and shoulders). The trial will enroll ~52 patients and follow them for 12 months post-transplant


    http://seekingalpha.com/news/2430976...d-injury-study
    "Talk without the support of action means nothing..."
    ― DaShanne Stokes

    ***Unite(D) to Fight Paralyses***

  • #2
    April 2015: This study is currently recruiting participants (yes, humans...)

    https://clinicaltrials.gov/ct2/show/NCT02163876?term=stemcells%2C+inc.&rank=

    Criteria
    Inclusion Criteria:
    • Male or female subjects age 18 to 60 years.
    • Traumatic cervical spinal cord injury (cSCI) with C5-C7 motor levels according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) as determined by the Investigator.
    • American Spinal Injury Association Impairment Scale (AIS) Grades A, B or C
    • Minimum of 12 weeks post-injury prior to Screening


    Sounds like its for chronics?
    Last edited by Moe; 04-17-2015, 12:16 PM.
    "Talk without the support of action means nothing..."
    ― DaShanne Stokes

    ***Unite(D) to Fight Paralyses***

    Comment


    • #3
      Originally posted by Moe View Post
      April 2015: This study is currently recruiting participants (yes, humans...)

      https://clinicaltrials.gov/ct2/show/NCT02163876?term=stemcells%2C+inc.&rank=

      Criteria
      Inclusion Criteria:
      • Male or female subjects age 18 to 60 years.
      • Traumatic cervical spinal cord injury (cSCI) with C5-C7 motor levels according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) as determined by the Investigator.
      • American Spinal Injury Association Impairment Scale (AIS) Grades A, B or C
      • Minimum of 12 weeks post-injury prior to Screening


      Sounds like its for chronics?
      If I'd understood the other websites, they said the injuries had to be less than 2 years old. So If read this correctly they are wanting an injury that falls in a time block of at least 12 weeks old but less than 2 years...
      http://spinalcordresearchandadvocacy.wordpress.com/

      Comment


      • #4
        Originally posted by GRAMMY View Post
        If I'd understood the other websites, they said the injuries had to be less than 2 years old. So If read this correctly they are wanting an injury that falls in a time block of at least 12 weeks old but less than 2 years...

        That is how I understand as well.

        It seems that I am forever waiting for a cellular trial to accept injuries at C4
        "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
          Originally posted by GRAMMY View Post
          If I'd understood the other websites, they said the injuries had to be less than 2 years old. So If read this correctly they are wanting an injury that falls in a time block of at least 12 weeks old but less than 2 years...
          That is correct. Here is the response I got.

          "after review of your message, you unfortunately do not qualify per the study protocol, because your injury was in 2007

          The protocol include ASIA A no more than 52 weeks ago and ASIA B & C no more than 104 weeks ago



          I am so sorry for the disappointing news" They didn't say that on clinicaltrials.gov

          Comment


          • #6
            Well shit.

            Comment


            • #7
              Yep!!!! However I got this from the Miami Project.

              Thank you for your interest in our FDA-approved Phase 1 Chronic Schwann Cell Clinical Trial. I am writing to inform you that we have reviewed your pre-screening information and have determined that you meet our preliminary requirements to move to our next phase of screening. However, we are required by the FDA to begin with thoracic level injuries and will not be moving into cervical injuries until at least early 2016. While you have meet our preliminary pre-screening requirements, we cannot guarantee that you will be screened or enrolled in this clinical trial when we move into cervical injuries. However, if you would like to collect the following medical documents and have a folder created for you here, I would be happy to receive these pieces of information in preparation for our cervical injury group:

              ? CD of your most recent spinal MRI – please mail this to me at the address listed below.
              ? Acute care discharge summary
              ? Acute care operative report
              ? Acute care MRI, CT, X-ray reports
              ? Rehab summary
              ? Copy of your most recent ASIA exam

              Please send me only the records listed above, not your entire medical chart.

              If you have any further questions, do not hesitate to contact me.

              Thank you.

              Comment


              • #8
                You goin for it?

                Comment


                • #9
                  Originally posted by #LHB# View Post
                  Yep!!!! However I got this from the Miami Project.

                  Thank you for your interest in our FDA-approved Phase 1 Chronic Schwann Cell Clinical Trial. I am writing to inform you that we have reviewed your pre-screening information and have determined that you meet our preliminary requirements to move to our next phase of screening. However, we are required by the FDA to begin with thoracic level injuries and will not be moving into cervical injuries until at least early 2016. While you have meet our preliminary pre-screening requirements, we cannot guarantee that you will be screened or enrolled in this clinical trial when we move into cervical injuries. However, if you would like to collect the following medical documents and have a folder created for you here, I would be happy to receive these pieces of information in preparation for our cervical injury group:

                  ? CD of your most recent spinal MRI – please mail this to me at the address listed below.
                  ? Acute care discharge summary
                  ? Acute care operative report
                  ? Acute care MRI, CT, X-ray reports
                  ? Rehab summary
                  ? Copy of your most recent ASIA exam

                  Please send me only the records listed above, not your entire medical chart.

                  If you have any further questions, do not hesitate to contact me.

                  Thank you.

                  LHB....nice
                  "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

                  Comment


                  • #10
                    Originally posted by Tbone57 View Post
                    You goin for it?
                    You referring to me? If so I haven't decided yet. Only qualm I have with it is I have to live in Miami for 10 months. I'm sure it sounds great to most but being a farmer its hard to be away that long. I am most defiantly interested in it though. It wasn't in the email but the lady took my information for Stemcell's Inc said they had plans to expand the trial and would call me and let me no when they did so. Other than that I will try just about anything what have I got to loose. Researcher's did there job getting the trial to us, I figure its mine/ours to get involved.

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                    • #11
                      Whatever u decide, Wish you the best!! I saw the Miami project trial but I'm not traumatic injury. Damn

                      Comment


                      • #12
                        My hang up on the Miami project trial is that there are 2 other trials coming up that I would rather take part in, Wise Youngs SCInetUSA and the Estem in Louisville. If I knew I for sure cant be a part of those, then Id be more likely to give the schwann cells a go. Well see. Im going to keep going through the sceening as well and learn about it at least.

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                        • #13
                          As an investor I can say even with this news, stem cell Inc. Stock is going down hard!

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