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    #31
    Originally posted by Wise Young View Post
    We are aiming to get the phase 2 trial (US102) started at the end of 2010 or beginning of 2011 and a phase 3 trial (US103) going in the United States in third quarter 2011, if we are successful in raising the funds.
    Hi, Dr. Young. Does this delay mean that the arrangements are altering again? As far as I know, the study completion date was originally scheduled for September 2011, thus the mentioned "shifting" is more than notable. Does 2012 still hold good as a realistic term for the general public? Thank you!

    Originally posted by Wise Young View Post
    If the results are positive and the treatment is approved by the US FDA, the treatments should become available in 2012.
    Knowing how things work (especially in SCI research), I think that a year or two might be added to this "best case scenario". I hope to be wrong, though. Good luck!
    2016

    Comment


      #32
      Originally posted by Wise Young View Post
      The study takes a year. Because it is an open label study, we will be carrying out the analysis along the way, as soon as the data is confirmed. The clinicaltrials.gov site does not provide data. We will be publishing it in a journal. It may take a year or more for the publication.
      Thank you, Dr. Young.
      Daniel

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        #33
        Overall, this looks extremely promising. Apx. how much do we need? And do you believe that chronics really have a chance? Will it be like a million dollars for a therapy?

        I can see what I can do with some concerts w/ very famous bands if I had more info..
        Birds Fly in Flocks, but Eagles Fly Alone...

        Comment


          #34
          Spidergirl-There is another thread talking about amounts, etc. From what I read, they have raised about $79,000 so far. They will need about $3 million for a phase 2 trial and $24 million for the phase 3 trial. The site to go to is www.justadollarplease.org Check them out when you have time.

          Comment


            #35
            I am curious as to how promising these trials are? I came here almost 5 years ago, when I was injured...and I am sorry to say but everyone was telling me that when they were injured...everyone would say they were told or read "3-5 years" This was the same for me. Looks like Wise' trials could be promising but if these really were proven in animals to work there should be hundreds of companies jumping at the chance too support.

            Either which way it gets the ball rolling for clinical trials which is Huge. I am totally more concerned as to why the government wont support curing people.

            I will check out the thread.

            Thanks.
            Birds Fly in Flocks, but Eagles Fly Alone...

            Comment


              #36
              Originally posted by momo3 View Post
              Spidergirl-There is another thread talking about amounts, etc. From what I read, they have raised about $79,000 so far. They will need about $3 million for a phase 2 trial and $24 million for the phase 3 trial. The site to go to is www.justadollarplease.org Check them out when you have time.
              um, this is even more disturbing. $1 a day is totally helpful but the goal is $27 million ???
              Birds Fly in Flocks, but Eagles Fly Alone...

              Comment


                #37
                Can someone please direct me to the thread where a rodent or animal is recovering from these therapies? Because I find it absolutely insane that something this Huge is not being funded.
                Birds Fly in Flocks, but Eagles Fly Alone...

                Comment


                  #38
                  Originally posted by spidergirl View Post
                  I am curious as to how promising these trials are? I came here almost 5 years ago, when I was injured...and I am sorry to say but everyone was telling me that when they were injured...everyone would say they were told or read "3-5 years" This was the same for me. Looks like Wise' trials could be promising but if these really were proven in animals to work there should be hundreds of companies jumping at the chance too support.

                  Either which way it gets the ball rolling for clinical trials which is Huge. I am totally more concerned as to why the government wont support curing people.

                  I will check out the thread.

                  Thanks.
                  I'm not in the loop but i suspect they will be applying for some N.I.H funding.

                  Why should the government support it when we don't support it.

                  By that I mean as an example I just went to NSCIA And the United Spinal Association web sites, I searched, clinical trial, Davies, Kierstead, Geron, SCInetUSA and other top stuff and got an old Geron story at one, and that was it.

                  http://www.spinalcord.org/

                  http://www.unitedspinal.org/

                  sad
                  http://justadollarplease.org/

                  2010 SCINet Clinical Trial Support Squad Member

                  "You kids and your cures, why back when I was injured they gave us a wheelchair and that's the way it was and we liked it!" Grumpy Old Man

                  .."i used to be able to goof around so much because i knew Superman had my back. now all i've got is his example -- and that's gonna have to be enough."

                  Comment


                    #39
                    Spidergirl,

                    Just testing a patient, preparing the cells in a GMP facility, operating and transplanting the cells, doing 6 weeks of rehabilitation, and evaluating the patient for a year will cost $100,000 per patient. The phase 3 trial that we are planning has 4 groups of 60 patients (lithium, cell transplant, cell-transplant plus lithium, rehabilitation only) or $24 million.

                    Please understand that spinal cord injury clinical trials cost millions of dollars in the United States. That is why there have been so few (or no) spinal cord injury clinical trials. The only trials are those that are being funded by companies. Geron is likely to spend over $40 million on their phase 1 trial alone. We have to start thinking in terms of such amounts.

                    A lot of people are just sitting around waiting for clinical trials to start without understanding the finances behind such trials. They think that all I need to do is to snap my fingers and $24 million will show up. People are expecting miracles and that somebody else will take care of the problem. Please, history suggests we don't have a sugar daddy who will take care of the problem.

                    The concept behind the $1 a day project is to find about 10,000 people in each city/region to support a clinical trial program. If 10,000 people donate $1 a day, that adds up to $3.65 million per year. If Austin (Texas), for example, had 10,000 people donating $1 a day, that will support the hospital there (Brackendridge) to 1-2 years of clinical trials.

                    We are of course not relying solely on the JustaDollarPlease to provide all the funding for the trial. We are working with the hospitals to reduce the costs. I am working with Stemcyte to help them raise money for the trial. We will be applying to the government for funding. Most of the centers that we are working with have other ways of raising the money in their region. For example, in Austin, the Lone Star Foundation is raising the funds for the trial in Brackenridge.

                    Wise.

                    Comment


                      #40
                      spidergirl; you're not alone. These questions are bewildering to us all. Bottom line is that Wise has said he is starting trials. We need these trials to start now and show results, real results, quickly. I'm not the only one expressing this; we all are expressing this in our differnet situations. We need progress not delays.

                      keeping on

                      Comment


                        #41
                        Why should the government support it when we don't support it.

                        By that I mean as an example I just went to NSCIA And the United Spinal Association web sites, I searched, clinical trial, Davies, Kierstead, Geron, SCInetUSA and other top stuff and got an old Geron story at one, and that was it.

                        You are exactly right, I went to both of these sites and found very little information. They have an Advocacy site as a combined effort, very little there as well...nothing about what Dr Young is doing, how to help with funding, etc...

                        So I emailed them, the email doesnt work. I now have a call into their office in DC. Will post any response.

                        Comment


                          #42
                          Originally posted by Wise Young View Post
                          Spidergirl,

                          Just testing a patient, preparing the cells in a GMP facility, operating and transplanting the cells, doing 6 weeks of rehabilitation, and evaluating the patient for a year will cost $100,000 per patient. The phase 3 trial that we are planning has 4 groups of 60 patients (lithium, cell transplant, cell-transplant plus lithium, rehabilitation only) or $24 million.

                          Please understand that spinal cord injury clinical trials cost millions of dollars in the United States. That is why there have been so few (or no) spinal cord injury clinical trials. The only trials are those that are being funded by companies. Geron is likely to spend over $40 million on their phase 1 trial alone. We have to start thinking in terms of such amounts.

                          A lot of people are just sitting around waiting for clinical trials to start without understanding the finances behind such trials. They think that all I need to do is to snap my fingers and $24 million will show up. People are expecting miracles and that somebody else will take care of the problem. Please, history suggests we don't have a sugar daddy who will take care of the problem.

                          The concept behind the $1 a day project is to find about 10,000 people in each city/region to support a clinical trial program. If 10,000 people donate $1 a day, that adds up to $3.65 million per year. If Austin (Texas), for example, had 10,000 people donating $1 a day, that will support the hospital there (Brackendridge) to 1-2 years of clinical trials.

                          We are of course not relying solely on the JustaDollarPlease to provide all the funding for the trial. We are working with the hospitals to reduce the costs. I am working with Stemcyte to help them raise money for the trial. We will be applying to the government for funding. Most of the centers that we are working with have other ways of raising the money in their region. For example, in Austin, the Lone Star Foundation is raising the funds for the trial in Brackenridge.

                          Wise.
                          I realize this must be quite frustrating, repeating to us the costs associated with trials and the need for funding. Most of us want to help and can do a much better job at promoting "Just One Dollar"

                          Will there be any time on July 22nd to have a discussion about funding? Status of NJ budget cuts? How we can restore that funding? I will be there and Random is planning to attend, she seems to be our best resource for information and who's who.

                          Comment


                            #43
                            Dr.Wise,I've already said this but I repeat:take a pig,paralyse it by damaging spinal cord,wait a month,restore it's spinal cord function-and you may replicate your therapy to humans.It can't cost too much,you don't need all this "crazy traveling" and it may be done in your lab.May be I completely ignorant and what I propose is nonsense so,please,correct me.

                            Comment


                              #44
                              Dr.Wise,do I have to say magic word "methylprednizolone" for causing you to reply me?

                              Comment


                                #45
                                Originally posted by kivi66 View Post
                                Dr.Wise,do I have to say magic word "methylprednizolone" for causing you to reply me?
                                What you should do is calm down. Although some times he make look like that, Dr. Wise is not a supercyborg from the future that can be everywhere replying everyone's questions at the same time.

                                He'll reply eventually, take it easy please.
                                Don't ask what clinical trials can do for you, ask what you can do for clinical trials.

                                Fenexy: Proyecto Volver a Caminar

                                http://www.fenexy.org (soon in english too)

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