Announcement

Collapse
No announcement yet.

ChinaSCINet Update

Collapse
This is a sticky topic.
X
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

  • Woo hoo!! Onward and FORWARD!! Come on FDA, time to MAN up!!

    Comment


    • There going to have to piece us back together like humpty dumpty. Hopefully this is the first piece.

      Comment


      • Originally posted by Jim View Post
        Eric,

        I work with Dr. Young at Rutgers.

        The ChinaSCINet Phase II Trial has been completed. 15 of 20 subjects are able to walk long distances using upper body supporting rolling walkers. 2 of the 15 are able to walk with walkers. Most subjects had major increases in their Spinal Cord Independence Measure scores, mainly in the mobility/bowel/bladder categories.

        Phase III Trials are now being planned to take place next year in China, US, Norway and India.

        [ATTACH]55475[/ATTACH]

        Thanks a lot for the clarification Jim, much appreciated. Are you able to comment on the progress of publication? I guess it's too early to predict whether the third phase will be first or second half of 2015?

        Jim would you consider a new sticky thread on the forums for Phase III when it commences? Something like a Q&A, with updates etc. But then again there probably isn't much more to say that hasn't been said over here, and could be unnecessary hype :P

        Kindest Regards

        Comment


        • Originally posted by Jim View Post
          Eric,

          I work with Dr. Young at Rutgers.

          The ChinaSCINet Phase II Trial has been completed. 15 of 20 subjects are able to walk long distances using upper body supporting rolling walkers. 2 of the 15 are able to walk with walkers. Most subjects had major increases in their Spinal Cord Independence Measure scores, mainly in the mobility/bowel/bladder categories.

          Phase III Trials are now being planned to take place next year in China, US, Norway and India.

          [ATTACH]55475[/ATTACH]
          hmm, sounds like this procedure really works. I've argued against the time consuming and overly expensive way clinical trials are held but its good to see that this one is actually producing good results. hopefully these results will pan out for all of us...

          Comment


          • Originally posted by Eric.S View Post
            hmm, sounds like this procedure really works. I've argued against the time consuming and overly expensive way clinical trials are held but its good to see that this one is actually producing good results. hopefully these results will pan out for all of us...
            Yeah absolutely, hope you've got the some answers, though there are many more on our minds. It seems like a massive hurdle to overcome, and I can't think of any therapy that has made it this far, in terms of trying to gain official approval. The results are promising, and it's a very strong foundation towards recovery. There still is a while before we see this therapy being adopted by healthcare bodies around the world. I can only speculate the resources required, such as dedicated labs, training for healthcare professionals - ESPECIALLY physiotherapists, due to the nature of intensive locomotor training. Here in the UK, I was at the NSIC (National Spinal Injuries Centre), at Stoke Mandeville Hospital, Aylesbury, which was regarded the "holy grail" of SCI research and rehab - I strongly and bitterly disagree, there is absolutely NO scope of recovery there, with a typical wait and see attitude, and minimal surgeries of fear of liability.

            Whilst I was thankful to see a dedicated physiotherapy gym, there were only a handful of standing frames, a couple PASSIVE leg bikes, ONE weight supported treadmill and one FES bike. The lone bike and treadmill were in heavy demand, and most of us were denied use of them as "they won't work on you." Which is understandable.

            But my question is to those that can answer, what does the locomotor training involve? Maybe a rough workout schedule? How on earth, and importantly how long before we see patients start receiving treatment? I know some mentioned "compassionate use" early treatment, but what countries would that apply to?

            I know I ask too many questions, but it seems my life has come down to sadly sitting behind a computer screen, as a keyboard warrior. This, of course, won't apply to all SCI people, there are many of you who are active and well, and make the most of life. But there are some who are in dire straights with daily living, and some even worse off - whether it be physically, mentally or FINANCIALLY.

            I want to work, get a job rather than rely on the state, and worry about being thrown in to a care home or old folks home. As it stands I had been THROWN in to a hostel expected to live off ?56 a week. I could try get a job, and all of this would be bearably, but oh God the PAIN is unbearable, the burning, stinging, feeling like my ankles are snapped clean off, stinging in my groin, the autonomic dysreflexia, and this bloody syringomyelia that's affecting my upper body. I'm sure most would say shut the hell up, man up, and get on with it. I do, - I just have this moment every now and then x

            Oops went off topic a bit. As you can see guys there are so many questions - would any moderators consider a sticky thread on the forums that have typical questions regarding phase three, that are answered in the original post? It's been done before but we need something specific to phase three, only if you have the time. I would like to offer some help, and I have plenty experience in moderating forums, and especially public relations (what can and can't be shared)

            Warmest regards possible, from this strained, torn, shreaded heart.

            Comment


            • Wise presented preliminary results almost two years ago, my understanding is that it does not work. See this video: https://www.youtube.com/watch?v=8VsK8lz6vZ8
              Pay attention at minute 37:50

              I hope at W2W more details will be presented.

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

              Comment


              • Originally posted by Wise Young View Post
                Dan,

                Patients are not permitted to pay for experimental therapies that have not yet been approved by the relevant governmental agencies, e.g. the FDA in the U.S. and the EMA in Europe. So, one cannot pay for participation in a clinical trial. The clinical trials are essential for obtaining evidence of safety and efficacy so that the treatment can be approved by the regulatory agencies, so that doctors can apply and insurance can pay for the therapy. On the other hand, it is possible to companies to apply for "expanded use access" to the therapy, as long as the expanded use does not interfere with the phase III trials needed to demonstrate the safety and efficacy of the therapy. Originally called "compassionate use" therapy, the expanded use access program allows companies to apply to allow patients to pay cost of the treatment that has been shown to be safe and has some promise but have not yet been approved. The treatment must be applied by qualified doctors, there should be no alternate therapy, and the condition must be serious (i.e. life-threatening or severely disabling). I have proposed to Stemcyte (the company providing the umbilical cord blood mononuclear cells) that they apply for expanded use access after the phase III trial starts in 2015. I am working closely with the company to help them expand the production of the cells so that it can treat thousands of people. So far, the company has provided several hundred units of umbilical cord blood for the clinical trials.

                Wise.
                Wise,

                does that mean that people with SCI may get access to therapies Originally called "compassionate use" therapy?

                I was just reading this article about the right to try (I see it has been introduced in New Jersey too):

                http://www.hoover.org/research/end-fda-paternalism

                "The Goldwater Institute this year brought the idea to three states - Colorado, Missouri, and Louisiana - and it was approved by the legislatures in all three unanimously. Meanwhile, the Arizona Legislature voted to refer Right to Try to the November 2014 ballot, and Right to Try measures also have been introduced in Delaware, Michigan, and New Jersey."



                Do you think SCI could fall into "The Right to Try" concept cosidering also life expectancy for people with high cevical injuries is significantly reduced?
                ( https://www.nscisc.uab.edu/PublicDoc...cts%202013.pdf )

                Paolo
                Last edited by paolocipolla; 08-18-2014, 04:40 AM.
                In God we trust; all others bring data. - Edwards Deming

                Comment


                • Originally posted by Jim View Post
                  Eric,

                  I work with Dr. Young at Rutgers.

                  The ChinaSCINet Phase II Trial has been completed. 15 of 20 subjects are able to walk long distances using upper body supporting rolling walkers. 2 of the 15 are able to walk with walkers. Most subjects had major increases in their Spinal Cord Independence Measure scores, mainly in the mobility/bowel/bladder categories.

                  Phase III Trials are now being planned to take place next year in China, US, Norway and India.

                  [ATTACH]55475[/ATTACH]
                  Norway? No-way, from what I know.

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

                  Comment


                  • Originally posted by Jim View Post
                    Eric,

                    I work with Dr. Young at Rutgers.

                    The ChinaSCINet Phase II Trial has been completed. 15 of 20 subjects are able to walk long distances using upper body supporting rolling walkers. 2 of the 15 are able to walk with walkers. Most subjects had major increases in their Spinal Cord Independence Measure scores, mainly in the mobility/bowel/bladder categories.

                    Phase III Trials are now being planned to take place next year in China, US, Norway and India.

                    [ATTACH]55475[/ATTACH]

                    Hello Jim, thank you for share this info, I have a question for you? how many of them were treated with placebos?

                    regards

                    Jose

                    Comment


                    • Originally posted by paolocipolla View Post
                      Wise presented preliminary results almost two years ago, my understanding is that it does not work. See this video: https://www.youtube.com/watch?v=8VsK8lz6vZ8
                      Pay attention at minute 37:50

                      I hope at W2W more details will be presented.

                      Paolo
                      HOLD ON. So it is INVOLUNTARY walking? Is this correct? How can COMPLETES walk if they haven't had any motor changes? So they walk involuntarily, right? Someone clear my confusion, my head hurts from trying to figure it out.

                      In the video Dr Wise says the patients didn't have any motor changes, but some ended up walking. So this means it does work Paolo? Forgive me, I don't have a huge understanding of the science behind all this Paolo, if it's not too much hassle could you please briefly clear this up for me? Because all this now seems very misleading

                      Regards
                      Last edited by taymas; 08-18-2014, 10:23 AM.

                      Comment


                      • Originally posted by paolocipolla View Post
                        Wise presented preliminary results almost two years ago, my understanding is that it does not work. See this video: https://www.youtube.com/watch?v=8VsK8lz6vZ8
                        Pay attention at minute 37:50

                        I hope at W2W more details will be presented.

                        Paolo
                        Many incompletes (C's and D's) who have very limited or in some cases, no walking ability at all, have either re-gained or vastly improved their ability to walk following intensive locomotor training. More often than not, these people's ASIA scores show no changes at all. So if we go by the logic you present Paolo, locomotor training "doesn't work" either, despite clear functional gains.

                        Comment


                        • Originally posted by taymas View Post
                          HOLD ON. So it is INVOLUNTARY walking? Is this correct? How can COMPLETES walk if they haven't had any motor changes? So they walk involuntarily, right? Someone clear my confusion, my head hurts from trying to figure it out.

                          In the video Dr Wise says the patients didn't have any motor changes, but some ended up walking. So this means it does work Paolo? Forgive me, I don't have a huge understanding of the science behind all this Paolo, if it's not too much hassle could you please briefly clear this up for me? Because all this now seems very misleading

                          Regards
                          Different spinal cord tracts are responsible for different functions. Voluntary control of bodily movements and reflexive control of movements are two different things. Most often the term "involuntary" walking means that people aren't choosing when and how to make steps - they just stand up, and the muscles go. It could be argued that this type of walking is not of any functional value, but to say there have been no changes in the subjects or that the procedure doesn't work is overkill.

                          Comment


                          • Originally posted by tomsonite View Post
                            Different spinal cord tracts are responsible for different functions. Voluntary control of bodily movements and reflexive control of movements are two different things. Most often the term "involuntary" walking means that people aren't choosing when and how to make steps - they just stand up, and the muscles go. It could be argued that this type of walking is not of any functional value, but to say there have been no changes in the subjects or that the procedure doesn't work is overkill.
                            Tomsonite,
                            I totally agree - it does "work" and has it's results. But could you elaborate on reflex vs motor control? So is it fair to say they are walking - but it's merely training their reflexes, and it is NOT voluntary on an individual muscle basis? You probably have a for better understanding than me.

                            For example, does this mean that if I had this therapy, I wouldn't be able to move my legs around in my wheelchair, like lift my leg to wear a sock? As Jim said COMPLETES are walking with or without aid. Although it would be better than nothing, my expectations were a tad high, dreaming of betting back on my motorcycle can

                            Can Jim or Wise also comment to clear this up?

                            Cheers

                            Comment


                            • Originally posted by jcalix View Post
                              Hello Jim, thank you for share this info, I have a question for you? how many of them were treated with placebos?
                              There is no placebo in phase II trials because the purpose is to prove safety. If safety and efficacy is shown in phase II, placebo is used in phase III as you see in the chart.

                              Originally posted by taymas View Post
                              HOLD ON. So it is INVOLUNTARY walking? Is this correct? How can COMPLETES walk if they haven't had any motor changes? So they walk involuntarily, right? Someone clear my confusion, my head hurts from trying to figure it out.
                              Tamas, I'm on vacation and don't have any time so read back in this thread where Dr. Young talks about the Central Pattern Generator, it's all explained there. It is hard to grasp why these subjects were able to gain assisted walking without motor control. I understood the theory but until I saw the videos of the walking vs the motor exams it wasn't clear.
                              This video was recorded before bowel/bladder improvement.

                              paolocipolla says:
                              Wise presented preliminary results almost two years ago, my understanding is that it does not work.

                              Paolo, what do you base the above statement on? How can you make this statement if you haven't seen the data?

                              Comment


                              • [QUOTE=paolocipolla;1743050]Wise presented preliminary results almost two years ago, my understanding is that it does not work. See this video: https://www.youtube.com/watch?v=8VsK8lz6vZ8
                                Pay attention at minute 37:50

                                I hope at W2W more details will be presented.

                                Your basing this statement on a 30 second portion of the video. Did you watch the whole video from beginning to finish or just the part where Wise says he believes the strands may still be growing and haven't reached the target yet. I recommend you watch the whole thing and try to glean some more information from it, thats your assignment. Report back with some good news or Santa is not going to visit you this year.

                                Comment

                                Working...
                                X