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Reeve Big idea - FDA approved for clinical trials!

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  • Reeve Big idea - FDA approved for clinical trials!

    Sign up if you can! Looks promising!

    http://reevebigidea.org/

  • #2
    Reeve is also a substantial investor in NRT for transcutaneous and implanted stim.
    T3 complete since Sept 2015.

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    • #3
      This isn't new???

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      • #4
        I wondered that as well .. apparently Matthew Reeve posted on the website today that it is an 'official' green light.

        So what happened to the $30 for 30 campaign then?
        Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.

        T-11 Flaccid Paraplegic due to TM July 1985 @ age 12

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        • #5
          Originally posted by lynnifer View Post
          I wondered that as well .. apparently Matthew Reeve posted on the website today that it is an 'official' green light.

          So what happened to the $30 for 30 campaign then?
          The fundraising for the Big Idea stalled about halfway I think. Once campaigns lose momentum it's tough to get them started again - even for the biggest brands. In the meantime it looks like they're going to get started on the clinical trial with the money they have raised to date and hope the rest comes along when needed. I don't think the recent internal staffing issue at Louisville has helped the timeline at all. This is real life unfortunately and time is not kind to spinal cord injury.

          In parallel Louisville has continued to implant subjects as part of their own programme - there's been at least 13 people implanted the last I heard. Could be a few more by now.

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          • #6
            Anyone know what the plan is for this trial?

            If successful will it result in approval for anyone to get the treatment?

            From their website it says "This will allow us to expedite epidural stimulation to the clinic."

            Seems like a statement that means they have a clear plan, or is it the kind of marketing that is sure to annoy the community.
            Last edited by niallel; 12-12-2017, 09:08 AM. Reason: added quote

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            • #7
              Let’s not get ahead of ourselves ... oral drugs can take 15yrs to reach market. ‘Course not sure about a ‘device.’

              What staffing issue ... are you talking one of the scientists leaving under Harkema and complaining about her methods and documentation? Last I conversed with her on FB, they were testing out software for lower motor neuron paralysis on their xcite equipment that is waaaaay overpriced.
              Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.

              T-11 Flaccid Paraplegic due to TM July 1985 @ age 12

              Comment


              • #8
                Originally posted by niallel View Post
                Anyone know what the plan is for this trial?

                If successful will it result in approval for anyone to get the treatment?

                From their website it says "This will allow us to expedite epidural stimulation to the clinic."

                Seems like a statement that means they have a clear plan, or is it the kind of marketing that is sure to annoy the community.
                Without being on the inside I would hazard a guess that Reeve alone will not/cannot deliver epidural stimulation to the masses.

                There will need to be a device manufacturer on board with a dedicated SCI device that is ready for market (safe and efficacious). The current pain stimulators (Medtronic, Boston Scientific & St Jude) being used are being re-purposed (with the permission of the manufacturer) for clinical/pilot studies only. The manufacturers wouldn't normally allow those to go to market in the context of SCI unless they have agreed to apply the bespoke adaptations made by the SCI researchers and repackaged for market.

                The other possibility is that a new player, like NeuroRecovery Technologies(NRT) (which Reeve is now participating in), would bring a suitable device to the market in parallel and that they use the clinical study results/data from other studies to expedite device approval. NRT would still need to show clinical data using any new device too - which would mean another study arm.

                There will also need to be a network of surgeons that are ready to implant (the easy bit I think as it is a relatively simple procedure) and neuro-mapping experts on hand to optimise devices and track progress (much more difficult and hence why Joel Burdick at Caltech is trying to build AI software for this).

                Personally I don't think the Big Idea scope will attempt to solve these market delivery challenges unless the mandate has changed recently. As I am not on the inside I could easily be wrong and they have a broader remit than before.

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                • #9
                  Ahh I see

                  "Exciting update: The University of Louisville has received unconditional approval from the U.S. Food & Drug Administration (FDA) to begin enrolling participants in The Big Idea study that will further explore the life-enhancing effects of epidural stimulation on people with spinal cord injury (SCI)."

                  "Note from Matthew Reeve: Big update on The Big Idea - Three years ago, we announced our most ambitious scientific initiative to date—The Big Idea. The campaign was inspired by groundbreaking research funded by the Reeve Foundation in which four young men, who were diagnosed with chronic complete spinal cord injury, had a device called an epidural stimulator implanted on their spine.I am thrilled to share with you that we now have the official green light from the FDA to start The Big Idea study and enroll participants. This is a huge milestone. And a big win for the Reeve Foundation and the community we serve.
                  We have stayed the course and kept our promise to expedite this innovative research. My father dreamed of a world of empty wheelchairs, never has that dream been closer to becoming a reality. This is our moment. This is our movement. This is your chance to be part of The Big Idea. #JoinReeve"

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                  • #10
                    I'm waiting on the transcutaneous from NRT. It has a low probability of helping me (ASIA A), but it's non-surgical and the stimulators aren't breakthrough devices for paras in general. Yes, it would be great to stand unassisted, but that's no like a quad recovering hand function.
                    T3 complete since Sept 2015.

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                    • #11
                      I don't know, does this somehow reconnect the brain to the extremities, or is it something to employ researchers?

                      In other news, I am bypassing the gyrations made by our research community and am selling plans for a self-directed study of a similar vein. Only $5.00 to me, and some lamp cord along with a variable DC power supply supplied by you.

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                      • #12
                        Originally posted by Andy View Post
                        I don't know, does this somehow reconnect the brain to the extremities, or is it something to employ researchers?

                        In other news, I am bypassing the gyrations made by our research community and am selling plans for a self-directed study of a similar vein. Only $5.00 to me, and some lamp cord along with a variable DC power supply supplied by you.
                        Don't forget rehab centers... how many working hours and for how many people every patient will bring in?

                        To then end up keep rolling around with no life-changing recovery of function..

                        Just my opinion based on the scientific evidence I know of.

                        Time will tell.

                        Paolo
                        In God we trust; all others bring data. - Edwards Deming

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                        • #13
                          Originally posted by paolocipolla View Post
                          Don't forget rehab centers... how many working hours and for how many people every patient will bring in?

                          To then end up keep rolling around with no life-changing recovery of function..

                          Just my opinion based on the scientific evidence I know of.

                          Time will tell.

                          Paolo
                          On its own you are probably right, but surely its a piece of the puzzle.

                          Stem Cells to replace missing material, get rid of the scar, growth factors to help grow, boost the signal with estim, retraining with rehab.

                          Who know if all of these pieces are needed, but progressing them so we know is surely the only way.

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                          • #14
                            I guess the trial protocol had to be fda approved? Louisville has done at least 11, so it’s not like the implant wasn’t already approved in a research capacity. The Big Idea was supposed to start early 2017 and it’s pretty much 2018 and hasn’t started.

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                            • #15
                              It always ends up like this.
                              "Life is about how you
                              respond to not only the
                              challenges you're dealt but
                              the challenges you seek...If
                              you have no goals, no
                              mountains to climb, your
                              soul dies".~Liz Fordred

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