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    #61
    Originally posted by Sue Pendleton View Post
    "If you or your loved one has a spinal cord injury that is more than 5 days old, we recommend staying healthy, being active, and participating in the studies that are currently approved, such as exercise, rehabilitation, spasticity, pain, etc."

    I'm not so sure of this. The more we support these studies the more NIH funding will go toward these kind of studies.
    .....
    I agree!

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

    Comment


      #62
      Originally posted by Sue Pendleton View Post
      ....
      ..
      I would apply a militarism to the research and publish system to speed it up: "Lead, follow or get the hell out of the way!"
      I would too, but it's unlikely we can make it happen... maybe we can have some positive effect by constantly controlling how the money are spent in the field.
      Cosider that the money of the SCI orgs are controlled by the scientific advisory boards & the reviewers (which all know each other). Most of them think that chronic SCI is too difficult to deal with so they just do acute as it's much easier to have some sort of positive results and therefore nice publications... that's how it works, not always, but most of the times.

      So in my opinion WE need to set the guide lines on how money should be spent to make sure chronic cure research is actually done.

      As an alternative there is always that crazy idea of an X-Prize

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

      Comment


        #63
        Originally posted by c473s View Post
        They do not see the numbers of SCI to do it with any speed. A multi center trial is nearly a requirement to recruit the numbers needed to enroll 8.
        c473s,

        would you agree that if it were a trial for chronic SCI the Miami Project could enroll all the 8 patients in about a year or maybe even less than a year?

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

        Comment


          #64
          Originally posted by swh2007 View Post
          A good first step would be to try to get 80 percent of the top 50 posters on the Cure Forum to agree on how to do that and then to get those 40 people or a close friend or family member to follow up with consistent long term action.
          That's an intersting proposal (I am sure StemCells&AtomBombs likes it too).
          One problem I have found in the past is that we all have a relatively limited/different understanding of what's going on so that makes it hard to agree on actions.
          Then consider also that even is we all had a good enough understanding of the field likely we'll have different visions on how to tackle the problems as we belong to different cultures, have different educations, have been in chair for differt number of years etc..
          So far it looks to me that all the attempts to unite a "critical mass" of the community have failed in short period of time, but I don't want to say we shouldn't try again, I am just pointing out some difficulties to keep in mind to have some possibilities of success.

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

          Comment


            #65
            Originally posted by KofQ View Post
            Quote:
            Originally Posted by GRAMMY [IMG]/forum/images/buttons/viewpost.gif[/IMG]
            Keep in mind that InVivo needed a safety study on schwann cells to add them to their acute scaffold they are proposing. That collaboration was announced quite some time ago.

            I don't think InVivo can afford to wait 3-5 years for MP to complete this trial. Their balance sheet suggests that they can't last more than another six months without some tangible progress. They have been talking about the scaffold approval, which was supposed to happen a couple of months ago at the latest (huge red flag). I think they announced a collaboration with MP just to signal to shareholders that they have a cash cow to go to for trial funds without having to dilute the share price or take on usurious financing terms to remain in operation.

            Quote:
            Originally Posted by c473s [IMG]/forum/images/buttons/viewpost.gif[/IMG]
            So far they have only Jackson in Miami as a recruiting site. With inclusion criteria similar to Geron's it will take a long time (years) to recruit 8 unless they find other sites to partner with.

            I think that's the idea. Keep the checks coming in from uninformed donors to keep the lights on and the 401k plans fully funded.

            It's the same situation at CDRF. They have an acute trial of Riluzole that isn't doing anybody any good.

            This trial is about saying "Look! We have a trial going, too." while other groups leapfrog past them on budgets one-tenth the size.
            Very likely this is all correct IMO.

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

            Comment


              #66
              Originally posted by Sue Pendleton View Post
              Either we need to redefine safety for conditions with no current treatment at the FDA or find other ways to speed up this process besides skipping acutes because by the time most care about paralysis it's too late for them or their loved ones. I would apply a militarism to the research and publish system to speed it up: "Lead, follow or get the hell out of the way!"
              The House has passed it, but lets hope the Senate passes legislation to establish the new user fees act for the FDA. It's not all of the answer, but it could help.
              http://spinalcordresearchandadvocacy...not-headlines/
              http://spinalcordresearchandadvocacy.wordpress.com/

              Comment


                #67
                Originally posted by paolocipolla View Post
                That's an intersting proposal (I am sure StemCells&AtomBombs likes it too).
                One problem I have found in the past is that we all have a relatively limited/different understanding of what's going on so that makes it hard to agree on actions.
                Then consider also that even is we all had a good enough understanding of the field likely we'll have different visions on how to tackle the problems as we belong to different cultures, have different educations, have been in chair for differt number of years etc..
                So far it looks to me that all the attempts to unite a "critical mass" of the community have failed in short period of time, but I don't want to say we shouldn't try again, I am just pointing out some difficulties to keep in mind to have some possibilities of success.

                Paolo

                Then you might as well give up the idea of the SCI community having any impact on SCI research. Do not expect more from the researchers than you expect from your own community.
                2012 SCINetUSA Clinical Trial Support Squad Member
                Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature.

                Comment


                  #68
                  Originally posted by paolocipolla View Post
                  c473s,

                  would you agree that if it were a trial for chronic SCI the Miami Project could enroll all the 8 patients in about a year or maybe even less than a year?

                  Paolo
                  A chronic trial would fill quickly "IF" the inclusion/exclusion criteria were much looser than what it is in this or the Geron trial. It would by default eliminate several criteria. The challenge then becomes the money for rehabilitation. In acute trials the "acute rehab" is funded by insurance or government and in smaller numbers by charity allowances.

                  Comment


                    #69
                    Everyone knows that all Wise needs is a Billionaire to give him the financial independence to do what he needs to do on this great humanitarian effort.

                    Most people on this site may remember my "rant" here of a few months ago about my pet peev, Billionairs dreaming up hairbrained tax avoidance schemes ie man made floating tax havens etc.

                    Well, Clive Palmer, a particularly divisive billionaire here in Australia has come up with the grand plan of building a replica titanic!
                    Of all the things this world needs, a replica titanic ego trip for this Oger would come some way down the list I would have thought. He has declared third class, yes that's third class passengers will be banned from entering first class areas!!! When asked at a press conference what the budget would be he said what ever the cost " I have the money".

                    His very good friend is fellow Australian and worlds richest woman Gina
                    Rhinehart, who he fully supports in her efforts to avoid paying her fare share of tax.
                    I dispair at what people in our community of the stature of Wise young could do for humanity with the support of these people rather than wasting there money on ego trips? My dad used to say "you can tell God doesn't like money by the people he gives it to" Well said dad, couldn't agree more!!

                    Comment


                      #70
                      Oh and BTW, I neglected to mention Gina Rhinehart, who was born into wealth, she has not created one cent in wealth herself has publicly stated she "does not donate to charitable causes.

                      Comment


                        #71
                        Originally posted by swh2007 View Post
                        Then you might as well give up the idea of the SCI community having any impact on SCI research. Do not expect more from the researchers than you expect from your own community.
                        I agree..
                        ...one thing we miss also is a leader of the community. It could be a person like it was Christopher Reeve or it could be an SCI org. with a clear plan & a good governance.
                        Probably most of us now agree not to support the Rick Hansen Foundation when it comes to a cure for chronic SCI.
                        On the other SCI orgs the discussion seems still open.
                        Probably it is necessary to have more than one SCI org to cover complementary parts of the whole SCI problem.
                        I think things are evolving, I try to put my two cents to agitate the situation, so that good things can emerge at the end.

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

                        Comment


                          #72
                          Originally posted by c473s View Post
                          A chronic trial would fill quickly "IF" the inclusion/exclusion criteria were much looser than what it is in this or the Geron trial. It would by default eliminate several criteria. The challenge then becomes the money for rehabilitation. In acute trials the "acute rehab" is funded by insurance or government and in smaller numbers by charity allowances.
                          Thanks c473s,

                          do you think the MP could do 8 people alone or a multicenter trial would still be needed even if it were a chronic SCI trial?

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

                          Comment


                            #73
                            Originally posted by adrien View Post
                            hello all
                            I just give my opinion ...
                            for me this therapy will not work at all, not a finger move over, I really hope I am wrong because I'm like you on the lookout for a therapy for me to walk again!
                            I understand why this therapy is so much noise on this forum, while the is to Gregoire Courtine much more exciting .. http://www.youtube.com/watch?v=kuDkkAK5tZ4

                            What do you think of the therapy to Gregoire Courtine?
                            Mr Wise Young, you have not commented on the therapy to Gregoire Courtine.
                            Can you make one?

                            And other, what do you think?
                            Adrien,

                            I agree that schwann cells alone probably will not work at all.

                            About Gregoire Courtine it's looks much better then what it is. He is exellent in marketing & communication for sure.
                            If you ck the model they have used you see that is very far from reality. Then they have not regenerated axons which is what we really need.
                            I still think this line of research is usefull, but is not my favorite.

                            Just my opinion for what it worth.

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

                            Comment


                              #74
                              Originally posted by paolocipolla View Post
                              Thanks c473s,

                              do you think the MP could do 8 people alone or a multicenter trial would still be needed even if it were a chronic SCI trial?

                              Paolo
                              Just my opinion but I believe a multi center trial is required to get 8 in any reasonable time frame.

                              Comment


                                #75
                                Originally posted by c473s View Post
                                Just my opinion but I believe a multi center trial is required to get 8 in any reasonable time frame.
                                c473s,

                                thanks for your opinion, which I respect, but could you say what are the bases of your opinion?

                                To organize a multicenter trial to do "just" 8 patients with chronic SCI for a phase I/II (that was the hypothesis here) it seems a waste of time and money to me, in fact to set up a multicenter clinical trial you'll need to allocate pesonnel for recruting clinical trial centers, training principal investigators and clinicians, develop a consensum on a clinical trial protocol etc...
                                I have discussed this issue with clinicians who had the experience to run/be involved - in multicenter clinical trials for SCI and they cleraly told me that is much better to avoid to have a multicenter trial when ever is possible as it can easily lead to the failure of a trial just because of the comlications I have mentioned above to set up a multicenter trial. A failure happened already at least once in an acute trial.

                                Then consisder the Stem Cell Inc trial, it is a phase I/II palnning to recute 12 patients (recuting is open to patiants from US, Canada & Europe... because people with chronic SCI can travel relatively easy, right? ) and they use just one center.
                                Why didn't they go for a multicenter trial?
                                Then consider also that Stem Cell Inc. is actually doing 3 pase I/II at the same time, infact they have planned to recrute patients ASIA A, B & C.

                                That is a very efficent way to run a trial IMO.

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

                                Comment

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