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Invivo scaffolding implant (first patient) showing early results!

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    #76
    From J. Napodano:

    InVivo Therapeutics (NVIV): It was a busy week for NVIV. First, they put out a press release noting that patients #9 and #10 were enrolled in INSPIRE, only #10 died. So, good news that enrollment is taking place, but bad news that #10 died. Then they drop the bomb that enrollment has been paused for the past 4-5 weeks while they work with the FDA around the informed consent - likely due to the deaths of #8 and #10. Ok, so June was completely lost and that explains the lack of newsflow, but the fact that the FDA is asking for a way to incorporate a "control" group in INSPIRE is a little concerning. I'm not sure if that slows down the potential HDE filing or not. It's like the FDA set the bar with the 25% convert rate (the OPC) but is now coming back and saying, "Well, we'd like more info on that please. And we also want to make sure 20% death is normal." Eek - that's bad news. However, good news is that INSPIRE has moved into Canada and that should help speed up enrollment given the high concentration of SCI patients in major cities around the country. All in all, a mixed week for InVivo - enrollment is picking up and there are reasons to believe it will continue to accelerate, but the FDA is new wildcard investors didn't need.
    In God we trust; all others bring data. - Edwards Deming

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      #77
      in vivo now has five patients that have improved.

      http://finance.yahoo.com/news/invivo...120000177.html

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        #78
        can anyone explain how these successful trials for acute's may eventually benefit chronic's when they moved into their new studies?

        does this help the chronic studies at all? Or are they starting over from scratch?

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          #79
          The plan for chronics is a slug of pre grown neuron sprouts (grown from the patient's own cells) that would be implanted into a void left after removing "scar" tissue and dead axons. It's hugely different from the acute approach as it requires surgical removal of tissue pre implant. AFAIK no clinical work on this idea has begun.
          T3 complete since Sept 2015.

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            #80
            Originally posted by JAMESRRR View Post
            can anyone explain how these successful trials for acute's may eventually benefit chronic's when they moved into their new studies?

            does this help the chronic studies at all? Or are they starting over from scratch?
            Here's the InVivo Therapeutics company LINK explaining their "Bioengineered Neural Trails" being designed specifically for chronic SCI. There's information here along with a video that shows the minimum invasive injection through the scar explaining the trail of matrix gel and cells in delivery with the new delivery device, potential human fetal derived cells with a partner stem cell company and the pre-clinical work that is underway.

            The acute one being talked about in this thread is a bioresorbable polymer scaffold that is designed for implantation (it's more like a solid). It provides structural support to the spared spinal tissue and a supportive matrix to facilitate endogenous repair processes. It degrades over several weeks.

            The knowledge gained from the regulatory standpoint will help them speed up the process a bit and they know more about what to expect. On the flip side, the chronic one is more complicated with the addition of a cellular product to contend with.
            Last edited by GRAMMY; 17 Aug 2016, 11:40 PM. Reason: spelling
            http://spinalcordresearchandadvocacy.wordpress.com/

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              #81
              Here is a good articles on Invivo

              https://tonic.vice.com/en_us/article...sing-paralysis

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                #82
                I liked that InVivo article, scimike. Thanks for posting it. There was a link within the article that talks about a topical solution that is applied to the spine. Anything non-invasive always makes my ears perk up. Here's where that link within your article leads: http://m.ucdmc.ucdavis.edu/publish/news/cme/11511
                Female, T9 incomplete

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                  #83
                  "Participants must be between 14 and 75 years of age and scheduled to undergo a spinal decompression/stabilization surgery within 72 hours following the initial injury. They will be randomized into three groups: two will receive the compound at two different doses and another will receive a placebo to the site of their injuries during surgery."
                  Lucky ones that get the real treatment, not so much the ones getting the placebo. Btw, I know what the placebo is, but I don't get what's the point for it, can they not just call it control group?
                  Last edited by Silvio GS; 12 Feb 2017, 4:22 PM.

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                    #84
                    Anything non-invasive is always good news.

                    I tried to follow the Invivo patients as some of them were very public. Jason, the first patient, has not posted in a very long time. I guess we have to wait for their report.

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                      #85
                      Oh...okay, silvio. So, it's a topical solution, but nobody qualifies to get to use it unless they are having spinal surgery. Hmmm. No, not what I was looking for. (Sad face)
                      Female, T9 incomplete

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