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Thread: InVivo Update

  1. #31
    Quote Originally Posted by Nowhere Man View Post
    Well, they've been testing their scaffold in rats and monkeys for what..10 years? They are a business looking for profit, which means they would want as large as a target market as possible (i.e. chronics). I think they know exactly how their scaffold would or would not help in a chronic incomplete injury.
    Are there any new primate or large mammal studies showing the proposed "chronic" treatment in anything other than an acute hemi-section injury model?

  2. #32
    Once is a Fluke, Twice is a Coincidence, Three Times is a Trend?

    To summarize what has been seen thus far in the pilot study of the NSS:

    -Patient #1 has gone from AIS-A to AIS-C in one month, which occurs in fewer than 5% of AIS-A patients with a T10-T12 injury.

    -Patient #2 remains AIS-A but has seen improvement in trunk stability, self-care, mobility, bowel and bladder function, and has regained partial sensation from the lower ribs to the hip on the right side of her body.

    -Patient #3 went from AIS-A to AIS-B in the first month after his accident, which is observed in fewer than 4% of patients with a T4 injury.

    -Perhaps most importantly of all, since this is first and foremost a safety study, is that there have been no serious adverse events due to the NSS or the surgical procedure.

    Looking at the results thus far, it appears as though a trend is developing in regards to the safety and efficacy of the NSS. InVivo still has two more patients to enroll in the pilot study, which could occur at any time but will most likely happen before the end of 2015. Even though this is only a safety study, it?s hard not to be impressed with the level of efficacy seen thus far with the first three patients.

    http://scr.zacks.com/News/Press-Rele...d/default.aspx
    "I'm manic as hell-
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    <----Scott Weiland---->

  3. #33
    Senior Member Stormycoon's Avatar
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    Oscillating field implant device can't think of what company that was. Did that get anywhere
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  4. #34
    http://www.invivotherapeutics.com/pr...inal-scaffold/

    CAMBRIDGE, Mass. (August 12, 2015) ? InVivo Therapeutics Holdings Corp. (NVIV) today announced that the Cooper Neurological Institute (CNI) in Camden, NJ has been added as a clinical site in the company?s ongoing pilot study of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury (SCI). CNI is a part of Cooper University Health Care, a network providing care to Southern New Jersey and the entire Delaware Valley. Steven Yocom, DO, Assistant Professor of Neurosurgery and Co-Director of the CNI Spine Program, has been named Principal Investigator at this site.

    ?Our group has a particular interest in spinal trauma and spinal cord injury. I?m excited that InVivo is approaching the significant unmet medical need in this field with such a novel technology,? Dr. Yocom said.

    Mark Perrin, InVivo?s CEO and Chairman, said, ?We are pleased to welcome Dr. Yocom and the Cooper Neurological Institute to our study. Dr. Yocom?s subject matter expertise will be valuable as we seek to enroll the final two subjects in our ongoing pilot trial.?

    There are currently 13 clinical sites that are open for enrollment:
    ?Barnes-Jewish Hospital at Washington University Medical Center, St. Louis, MO
    ?Barrow Neurological Institute ? St. Joseph?s Hospital and Medical Center, Phoenix, AZ
    ?Carolina Neurosurgery and Spine Associates/ Carolinas Rehabilitation, Charlotte, NC
    ?Cooper Neurological Institute, Camden, NJ
    ?Goodman Campbell Brain and Spine / Indiana University Health Neuroscience Center, Indianapolis, IN
    ?Keck Hospital of University of Southern California, Los Angeles, CA
    ?Medical College of Wisconsin/Froedtert Hospital, Milwaukee, WI
    ?Oregon Health & Science University, Portland, OE
    ?Rutgers New Jersey Medical School, Newark, NJ
    ?University of Arizona Medical Center, Tucson, AZ
    ?University of California/Davis Medical Center, Sacramento, CA
    ?University of Kansas Medical Center, Kansas City, KS
    ?University of Pittsburgh Medical Center Presbyterian, Pittsburgh, PA

    This is the company?s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The Investigational Device Exemption (IDE) pilot study has been approved by the FDA and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. Following the pilot trial, InVivo expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE).

    For more information, please visit the company?s ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110
    "I'm manic as hell-
    But I'm goin' strong-
    Left my meds on the sink again-
    My head will be racing by lunchtime"

    <----Scott Weiland---->

  5. #35
    You think they will have trials in the cervical part of the spine? I noticed trials are only for t-2 - l-1 .

  6. #36
    Quote Originally Posted by Oneslowsaleen View Post
    You think they will have trials in the cervical part of the spine? I noticed trials are only for t-2 - l-1 .
    Well they talk about applying there technology to cervical injuries, they just haven't announced when they'll start. Below are some excerpts from their homepage.

    • Received Humanitarian Use Device (HUD) designation (April 2013)
    – Indicated population must be fewer than 4,000 patients in the US
     InVivo HUD: patients with complete, non-penetrating thoracic and cervical SCIs
    – Simpler path to approval (safety and probable benefit) through
    humanitarian device exemption (HDE)
    ************************************************** ************
    • New Clinical Programs in Expanded Populations
    – Acute Cervical Spinal Cord Injuries
     Humanitarian Use Device designation obtained for this population
     Enables InVivo to pursue rapid, streamlined program via HDE approval
    – Premarket Approval (PMA) path
     Ability to expand to entire acute SCI population
    ? Thoracic complete SCI
    ? Cervical complete SCI
    ? Cervical and thoracic incomplete SCI

    http://www.invivotherapeutics.com/wp...5-15_FINAL.pdf
    "I'm manic as hell-
    But I'm goin' strong-
    Left my meds on the sink again-
    My head will be racing by lunchtime"

    <----Scott Weiland---->

  7. #37
    Is there any collaboration with Dr. Young?
    Didn't they sign a peace accord with the Miami project? Does anyone else feel like there really isn't any collaboration. Slide shows at symposiums discussing theorys washed of any trade secrets; and, poof. . . back behind glass tower walls with the drawbridges up.
    May not be true, certainly feels like it. I know individual trials need to be completed first, but can we see a public round-table discussing putting Dr. Youngs cells in Invivos silly putty and adding in whatever the Miami project has been working on for 20 years. Why not at one of those poker tables in Las Vegas? That would be some theoretical discussion the boots-in-the-wheeled-chairs would applaud.
    please . . .test what you already know; and give us what you have. we may not be dying, but we certainly are not living either

  8. #38
    Quote Originally Posted by Nicksdad View Post
    Is there any collaboration with Dr. Young? I know individual trials need to be completed first, but can we see a public round-table discussing putting Dr. Youngs cells in Invivos silly putty and adding in whatever the Miami project has been working on for 20 years.
    I've never been to an open house at Rutgers to hear anything about scaffolds.

    The chronic stem cell trial with MP is recruiting for a Phase 1 safety now and InVivo just finished with their Phase 1 safety on 5 acute patients. I would imagine MP would want to get further along in the trial stages to see if it would make any sense to put their cells in the scaffold. Mayo clinic just completed some animal experiments and found their Schwann cells didn't work in a scaffold. LINK



  9. #39
    Wasn't the primary the primary purpose of the Christopher and Dana Reeve Paralysis Act to promote or encourage collaboration? That always seemed to be one of Superman’s big disappointments. What a colossal wasted effort that letter writing campaign was! Not even sure if the foundation cares much about collaboration now… They appear to be cheery-picking specific projects they want to support, hopefully better than the federal government selected solar companies to invest in, and occasionally passing out a fes bike.



    http://sci.rutgers.edu/forum/showthr...=1#post1698840
    Last edited by Nicksdad; 09-25-2015 at 12:11 PM. Reason: added link to a earlier post
    please . . .test what you already know; and give us what you have. we may not be dying, but we certainly are not living either

  10. #40
    Quote Originally Posted by ineedmyelin View Post
    Well they talk about applying there technology to cervical injuries, they just haven't announced when they'll start. Below are some excerpts from their homepage.

    ? Received Humanitarian Use Device (HUD) designation (April 2013)
    ? Indicated population must be fewer than 4,000 patients in the US
     InVivo HUD: patients with complete, non-penetrating thoracic and cervical SCIs
    ? Simpler path to approval (safety and probable benefit) through
    humanitarian device exemption (HDE)
    ************************************************** ************
    ? New Clinical Programs in Expanded Populations
    ? Acute Cervical Spinal Cord Injuries
     Humanitarian Use Device designation obtained for this population
     Enables InVivo to pursue rapid, streamlined program via HDE approval
    ? Premarket Approval (PMA) path
     Ability to expand to entire acute SCI population
    ? Thoracic complete SCI
    ? Cervical complete SCI
    ? Cervical and thoracic incomplete SCI

    http://www.invivotherapeutics.com/wp...5-15_FINAL.pdf
    I wonder how many more trial sites on top of the current 13 they will add for the next expanded clinical trial programs.

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