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

  1. #1
    Senior Member Moe's Avatar
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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

  2. #2
    Senior Member Moe's Avatar
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    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 at 12:16 PM.

  3. #3
    Quote 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...

  4. #4
    Senior Member lunasicc42's Avatar
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    Quote 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
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    Quote 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

  6. #6
    Well shit.

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    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.

  8. #8
    Senior Member Tbone57's Avatar
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    You goin for it?

  9. #9
    Senior Member lunasicc42's Avatar
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    Quote 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!!!! "


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  10. #10
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    Quote 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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