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Thread: InVivo Therapeutics Announces Bioengineered Neural Trails? Program for Chronic Spinal

  1. #11
    eLedbetter
    Guest
    thanks Grammy for the additional info. So, will they have to go through the same paperwork etc. once they move to the chronic cervical levels? And did they say they were able to, fast track this somewhat with the FDA?

  2. #12
    Quote Originally Posted by eLedbetter View Post
    thanks Grammy for the additional info. So, will they have to go through the same paperwork etc. once they move to the chronic cervical levels? And did they say they were able to, fast track this somewhat with the FDA?

    InVivo has plans to initiate a study for acute, neurologically complete cervical SCI in the middle of 2016, but it's just for the scaffold and won't require all new permissions since they've already got a safety record going. (The scaffold material went through the FDA in a "device" category so it was indeed easier and faster on the paperwork all the way around. The OP in this particular thread on the bioengineered neural trails will require a lot more paperwork and preclinical work on safety since the scaffold will contain neural stem cells and they are shooting for late 2016 with the FDA. Depending on what neural cells they decide on, it potentially could go a bit quicker if the chosen cells have a safety track record going.

  3. #13
    eLedbetter
    Guest
    thank you. This seems like, at least in theory, one of the efforts that could have the most promise. Here's hoping.

  4. #14
    The most recent video of the first patient was stunning. I'm sorry I didn't save the link.

  5. #15
    Quote Originally Posted by eLedbetter View Post
    thank you. This seems like, at least in theory, one of the efforts that could have the most promise. Here's hoping.
    The scaffold applied at a very acute stage of injury does indeed appear to help most of the patients so far. We'll know more when the final data is compiled and published.

  6. #16
    Quote Originally Posted by GRAMMY View Post
    The scaffold applied at a very acute stage of injury does indeed appear to help most of the patients so far. We'll know more when the final data is compiled and published.
    I have been watching this and hope that in the future they will work more with Chronics.

    Its also not a bad company to invest in right now.

  7. #17
    Senior Member lunasicc42's Avatar
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    Quote Originally Posted by GRAMMY View Post
    The scaffold applied at a very acute stage of injury does indeed appear to help most of the patients so far. We'll know more when the final data is compiled and published.

    Do you know when this data is suppose to be published and presented?
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  8. #18
    Quote Originally Posted by lunasicc42 View Post
    Do you know when this data is suppose to be published and presented?
    The clinical trial must be completed first. Once it is concluded, they begin analyzing the data and preparing manuscript for publication. Journal submissions, rewrites and clarifications take more time but do finally result in it's publication. It's hard to estimate an exact time line for all of it. It varies greatly. LINK

    Estimated Enrollment:10
    Study Start Date:April 2014
    Estimated Primary Completion Date:February 2016 (Final data collection date for primary outcome measure)

    Primary Outcome Measures:
    • Incidence of all Adverse Device Effects of any kind/seriousness.
    • [Time Frame:6 months ]

    Last edited by GRAMMY; 12-20-2015 at 03:43 PM.

  9. #19
    Quote Originally Posted by cfx View Post
    I have been watching this and hope that in the future they will work more with Chronics.

    Its also not a bad company to invest in right now.
    The newly secured patents along with the provisional patent application and the intellectual property for the Bioengineered Neural Trails puts the chronic piece on their future map in a big way.

  10. #20
    eLedbetter
    Guest
    this is when it would be great if they could fast track some of this stuff

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