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    Again, thank you Jim for your response and optimism. I am sure that by July 10, we're going to hear some good news from the FDA.
    Jim, hopefully when we get the OK from the FDA, how long after that, are you guys anticipating that we start the trails in America?
    Also, any news from India Re: the trails?
    Do you reckon that they'll start at the same time as the US trails?

    Thanks

    Comment


      Originally posted by Jim View Post
      We are very pleased with the FDA, they have been very helpful and a pleasure to work with.

      Moe, no one is making excuses, trials are very hard to pull off, especially in three new clinical trial networks around the world, at the same time. We don't yet have a clinical trial network in Norway, Wise hasn't had the time to go there and organize it. After ChinaSCINet completed the Phase II trail (3 years ago) the government declared cells would no longer be allowed to be imported. (Wise has since started a company in Hong Kong to collect and process cord blood. All of his profits will be put into a SCI Fund for US research/clinical trials.) Around that time Wise set up a clinical trial network in Taiwan, they will be taking part in the IIb trials. Shortly after this was announced, China lifted the restrictions on importing cells. The plan is to involved them in the Phase III. A network has also been set up in India, they will also take part in the IIb trial. They started the walking program a few months ago.

      The three year follow up has not been done yet because the money is being raised and logistics worked out. And yes, many of the patients live in areas that are not accessible by car, so teams have to be sent to them.

      I know sci sucks, but that's not an excuse to be an ungrateful prick.
      Sorry my bad, When I read that things were going to happened by the end of x time, I was expecting for it to happen by x time... all this wolf calling over these past few years just flushed my optimism down the drain.

      As for the ungrateful prick remark, I'm not offended but let's not kid eachother here: I owe no favors; this is not Mother Theresa finding a cure for free on her spare time... This is a multi-billion dollar industry that has been fed tons of money in our behalf for decades. That being said it's becoming obvious to me now that the biggest threat is if all SC victims disappeared or got all cured suddenly. Labs, researchers, universities would lose billions if it ended. So it makes sense that they maintain hype and postpone timelines.

      Nothing personal, your not to blame at all, just my 2 cents, I'll print every page of this tread and eat all the words if proven wrong.
      "Talk without the support of action means nothing..."
      ― DaShanne Stokes

      ***Unite(D) to Fight Paralyses***

      Comment


        Is the “SCI network” like the EU? In that I mean say they find a cure in England would it be legal in the US under FDA rules or is that where y’all are trying to get with it?

        Comment


          Originally posted by #LHB# View Post
          Is the ?SCI network? like the EU? In that I mean say they find a cure in England would it be legal in the US under FDA rules or is that where y?all are trying to get with it?
          No, they are entirely separate. In the EU, their equivalent to the FDA is the European Medical Agency (EMA). There's no reciprocal agreements from country to country as far as I'm aware. Most try to comply with the strict regulations set forth in the US in order to meet the high standards and market easier in the future when importing. They try to make everything FDA compliant but I don't believe any other country gets an automatic "free pass". Many things have to be redone or additional animal studies submitted in order to meet all the rigorous standards and qualifications to trial things.

          http://www.ema.europa.eu/ema/index.j...ent_000629.jsp
          Last edited by GRAMMY; 13 May 2018, 1:36 PM.
          http://spinalcordresearchandadvocacy.wordpress.com/

          Comment


            SCI community crowd-funding cord blood mononuclear cell treatment?

            @Jim, as Wise has gotten positive results, if funding is an issue then why not create a pitch using kickstarter or any alternative to pay-forward the treatment or clinical trials? As we are after improvements it matters little if the treatment is delivered in the US, China or India.

            Given SCI folks are paying $20k-$50k for unproven treatments in Panama, China, India, Thailand or a number of other places, why not have them invest in something that is working?
            Last edited by Pauly1; 15 May 2018, 10:10 AM.

            Comment


              Originally posted by GRAMMY View Post
              No, they are entirely separate. In the EU, their equivalent to the FDA is the European Medical Agency (EMA). There's no reciprocal agreements from country to country as far as I'm aware. Most try to comply with the strict regulations set forth in the US in order to meet the high standards and market easier in the future when importing. They try to make everything FDA compliant but I don't believe any other country gets an automatic "free pass". Many things have to be redone or additional animal studies submitted in order to meet all the rigorous standards and qualifications to trial things.

              http://www.ema.europa.eu/ema/index.j...ent_000629.jsp
              So is there anyway you could get it where that would be possible Mrs Powell? I know you would have to go through Congress, but wouldn’t it be a good thing to be connected for a “compassionate use” type of treatment?

              Comment


                Any updates you can share with us Jim?

                Comment


                  How’s Dr Young doing? He hasn’t been up here in a couple years probably.

                  Comment


                    Jim, What info will we need to provide for the selection criteria for either the trial or compassionate use? I'd assume a recent MRI and ASIA score but what else may be required?
                    Thanks

                    Comment


                      Originally posted by tumbleweeds View Post
                      Jim, What info will we need to provide for the selection criteria for either the trial or compassionate use? I'd assume a recent MRI and ASIA score but what else may be required?
                      Thanks
                      Jim? How recent of an MRI or ASIA test do we need please? Thanks.

                      Comment


                        I'd be surprised if the MRI was an actual requirement for the candidate to go get on their own. Would they like one if you happened to have one? Yes. Might they want a new one on the study's dime? Maybe.
                        I could be wrong, I just don't think they'd expect people to have the means to just go get an MRI. They aren't cheap.
                        I also think they'd have to do their own ASIA test.
                        Curious what Jim has to say about it. Good question to bring up Tumbleweeds.

                        Comment


                          Right on Barrington.

                          Comment


                            Thank you guys. Was looking to avoid a last minute scramble if either was a requirement.

                            Comment


                              Just got the newsletter last week!!! I really hope the FDA approves this trail!!!

                              Comment


                                Originally posted by Sparky831 View Post
                                Just got the newsletter last week!!! I really hope the FDA approves this trail!!!
                                an e-newsletter or physical mail... I haven't gotten anything
                                "That's not smog! It's SMUG!! " - randy marsh, southpark

                                "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


                                2010 SCINet Clinical Trial Support Squad Member
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