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  • Jim when to hear some breaking news for lumbosacral injury patients from u or wise?

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    • Originally posted by Jim View Post
      This therapy won't be available to all until it is approved by, I believe, the Chinese Ministry of Health and the US FDA.
      Jim,
      What are the chances of the Chinese Ministry passing it and not the FDA? Just curious

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      • Jawaid, our lab is working very hard on it.

        jfreg, I really don't have enough experience to answer.

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        • Originally posted by Jim View Post
          Jawaid, our lab is working very hard on it.

          jfreg, I really don't have enough experience to answer.
          Thanks Jim, just curious as it seems here in the USA we have such a skeptical group I was curious if you hear anything or somebody knows anything about the distinction between both groups. Again thank you Jim for all you do on here..

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          • Originally posted by dan#3 View Post
            dr.wise young
            i would like to pay for your treatment in china as soon as possible so it doesn't cost your organization anything ,if you could tell me what it costs including all physical therapy,before and after treatment. I've suffered from a contusion of my t-11 followed by ascending eschema to my t-5 since June 2000 ,seems to be blood flow blockage causing my paralysis.if that's currently my injury then I think I could benefit from your treatment . thank you dan sheean [olivefarms@copper.net 530-620-2768]
            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.

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            • Dr. Young,

              If everything goes well with the trial and it is approved. How are you and your team planning to dealing with the surge to get the therapy?

              Comment


              • Dr. Wise,
                If the expanded use access of the therapy is approved by the FDA in the U.S. or the EMA in Europe, what about other countries such as China?Thank you.

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                • tang,

                  If you read Jim's earlier post, I think he mentioned the Chinese Ministry of Health - I think the trial will be to gain approval of them as well as the US.

                  Dr Wise
                  When this therapy has been approved, (hopefully,) does it exclude people such as myself, who have developed syringomyelia as a result of a traumatic injury? (such as burst fractures due to road traffic accidents or other traumatic situations.) I know that one of the trial participation exclusions are a large syringomyelia. I have one from T5 to C1/ very close to brain stem, and am now an ASIA B from being an ASIA A a year and a half ago. One of the consultants said they wouldn't touch with this therapy. So of course, I'm now very curious.

                  We can't thank you and all those involved enough. And thanks Jim for your work in the forums, and out.


                  Regards

                  Comment


                  • Originally posted by taymas View Post
                    tang,

                    If you read Jim's earlier post, I think he mentioned the Chinese Ministry of Health - I think the trial will be to gain approval of them as well as the US.

                    Dr Wise
                    When this therapy has been approved, (hopefully,) does it exclude people such as myself, who have developed syringomyelia as a result of a traumatic injury? (such as burst fractures due to road traffic accidents or other traumatic situations.) I know that one of the trial participation exclusions are a large syringomyelia. I have one from T5 to C1/ very close to brain stem, and am now an ASIA B from being an ASIA A a year and a half ago. One of the consultants said they wouldn't touch with this therapy. So of course, I'm now very curious.

                    We can't thank you and all those involved enough. And thanks Jim for your work in the forums, and out.


                    Regards
                    Taymas,

                    Our trials did exclude those subjects who had large syringomyelic cysts that occupied more than a third of the width of the spinal cord. The reason was that we did not want to inject the cells into the cyst. If our trial shows that the umbilical cord blood mononuclear cells are effective for chronic complete spinal cord injury, one possibility is that doctors may first operate to untether your spinal cord and collapse the syringomyelic cyst, confirm that it is gone, and then transplant the cells into the spinal cord.

                    Wise.

                    Comment


                    • Originally posted by Wise Young View Post
                      Taymas,

                      Our trials did exclude those subjects who had large syringomyelic cysts that occupied more than a third of the width of the spinal cord. The reason was that we did not want to inject the cells into the cyst. If our trial shows that the umbilical cord blood mononuclear cells are effective for chronic complete spinal cord injury, one possibility is that doctors may first operate to untether your spinal cord and collapse the syringomyelic cyst, confirm that it is gone, and then transplant the cells into the spinal cord.

                      Wise.
                      Thank you Dr, I appreciate your reply

                      I understand the requirement of untethering, but surgeons are keen on using a shunt once untethering is done. I would imagine the shunt would have to be removed prior to implantation of cells? Theoretically, would there be an issue implanting the cells UPON collapsing the syrinx in the SAME surgery? I'm just not convinced that my syrinx, extending up to C1/2 could ever be collapsed completely - maybe we have pessimistic surgeons here in the UK

                      Regardless, stay strong Dr, I can't imagine the sheer load on you and your team; gathering gargantuan amounts of data, and trying to get published.

                      Warmest regards.

                      Comment


                      • This thread is so long and veers off course to some degree so it's had to tell if there is any early indication whether this procedure is effective or not. Simple question, is there any early indication?

                        Comment


                        • Originally posted by Eric.S View Post
                          This thread is so long and veers off course to some degree so it's had to tell if there is any early indication whether this procedure is effective or not. Simple question, is there any early indication?
                          Hi Eric don't know if I'm going to be much help, but the gist I'm getting is they can't say yet until they publish their findings officially (every trial needs this I imagine) - this of course is in relation to Phase II. Whether or not it is "effective," they will have to confirm their findings in a Phase III trial. Of course it would have to be effective to go to Phase III in the first place, so it is mainly for confirmation and to gain regulatory approval. There was some mention if you see the last 10 pages, that we may be able to see this therapy AS the third phase commences, on grounds of "compassionate use", if it is proven to be safe and effective "what Phase I and II are about.

                          Anyone feel free to correct me if I'm wrong.

                          Regards

                          Comment


                          • Originally posted by taymas View Post
                            Hi Eric don't know if I'm going to be much help, but the gist I'm getting is they can't say yet until they publish their findings officially (every trial needs this I imagine) - this of course is in relation to Phase II. Whether or not it is "effective," they will have to confirm their findings in a Phase III trial. Of course it would have to be effective to go to Phase III in the first place, so it is mainly for confirmation and to gain regulatory approval. There was some mention if you see the last 10 pages, that we may be able to see this therapy AS the third phase commences, on grounds of "compassionate use", if it is proven to be safe and effective "what Phase I and II are about.

                            Anyone feel free to correct me if I'm wrong.

                            Regards

                            which phase is the trial in currently? Even though its purpose is safety I would imagine there would be some early indication whether a trial works or not in the first phase.. if more than 1 person is seeing returns in functions i'd imagine thats from the procedure.

                            Comment


                            • Originally posted by Eric.S View Post
                              which phase is the trial in currently? Even though its purpose is safety I would imagine there would be some early indication whether a trial works or not in the first phase.. if more than 1 person is seeing returns in functions i'd imagine thats from the procedure.
                              Hey Eric,
                              I believe we are now awaiting the beginning of Phase III, which seems like it will be 2015.

                              Now I don't know if I can answer the question on effectiveness, but I did read a press release which seemed positive on the ChinaSCINet site, (I think). We will have to await publication of the findings to be certain (of previous Phase). But my personal impression was that majority of participants had
                              positive results. PM me and I'll see if I can find the link for you. As I am not affiliated with anyone here, I only speak as a fellow SCI. I know that there seems to bee TOO much ambiguity, but they can't be transparent or they jeopardise their findings/credibility (for whatever reason; ethics, false hope, I don't know only they can answer.) We will have to wait so they do things properly. I would love to hear an update, but if it is damaging to any process then I don't want to know.

                              Regards.

                              Comment


                              • 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.

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