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FYI: INSPIRE (Invivo Therapeutics acute trial) HDE phase 3 is 85% enrolled!

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  • FYI: INSPIRE (Invivo Therapeutics acute trial) HDE phase 3 is 85% enrolled!

    Trial highlights:

    Zero safety concerns thus far.
    Only 3 more to enroll.
    There has been either 10 or 11 patients that have hit the 6 month evaluation window (6 0r 7 to go plus the 3 more to enroll) and out of these have been 7 AIS conversions, two very borderline such that they have "reverted" and there are 5 permanents with those 2 who could certainly reconvert. Average run rate seems to be about half likely to convert. There have been three conversions to the AIS C level. The FDA agreed that the Objective Performance Criteria would be 5 out of 20. I'm estimating they'll end up with 9 or 10 and retain the zero safety issues. My conclusion as this is the HDE pathway, they will be approved in 2018 and will usher in a new acute SCI standard of care. Furthermore, this entree into the space will foster collaborations with other partners wanting to add enhancements to this scaffold, like Schwann cells, stem cells, small molecules, proteins, etc. The world will change when this goes to market and outcomes will not only improve all around, but will get better over time as this implant gets enhanced with other materials.

  • #2
    Here's hoping.

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    • #3
      Great news!
      I was injured 2 weeks after my 16th birthday on June 14th, 2004. My level of injury is C5 complete, but I can move my wrist.

      My screen name comes from the movie The Eternal Sunshine of the Spotless Mind

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