Announcement

Collapse
No announcement yet.

ChinaSCINet Update

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

    Originally posted by Barrington314mx View Post
    When i first started reading on here, I was reading that these trials would be coming to the US in 2012. Now im seeing the 2014 thrown around.
    Barrington,

    I had hoped that we might have been able to get the trials going in 2012. We are working very hard to get the trials going in 2013.

    Before we can do the trials in the U.S., we must get obtain permission from the FDA. We are planning to submit the IND when we get our 6-month data from our current trials.

    We are raising funds for the trials. It will cost over $100,000 per subject and we are planning to test about 120 subjects in the U.S. We need $12 million. It will have to come from many sources.

    I am setting goals and pushing many people to work hard to attain those goals.

    Wise.

    Comment


      Originally posted by Lynnifer
      I too, hope he's onto something but I find that doubtful during the first time out ... and that's okay. What worries me is that I don't see many lining up with proposed treatments???
      I wanted to address one of Lynnifer's comments. She pointed out that she doesn't see many people lining up, presumably with therapies for the trials to come whether umbilical cord blood and lithium turn out to be effective. Many companies and investigators have approached ChinaSCINet to test therapies. Let me mention just a few that we are working with.

      1. Cethrin. We are working with Lisa McKerracher to bring Cethrin to phase 3 trial. For example, we are hoping to do a U.S. phase I/II trial comparing UCBMC+lithium and UCBMC+lithium & Cethrin. This would be precursor to a phase III trial comparing UCBMC+lithium, Cethrin, and UCBMC+lithium & Cethrin. Since we now have phase I/II safety data for UCBMC+lithium and Cethrin in chronic SCI and Phase I/II safety data for Cethrin in subacute spinal cord injury, we believe that we can get regulatory approval of use of the combination of the three treatments for chronic SCI relatively quickly, as soon as GMP facilities can be identified for manufacturing the Cethrin.

      2. Soluble Decoy Nogo Receptor. We are working closely with Axerion to test and move their soluble decoy nogo receptor to trial. Strittmatter has published exciting chronic spinal cord injury animal results, showing that this treatment improves recovery of function in rodents. The treatment appears to be safe (because the soluble nogo receptor protein binds to molecules that bind to the Nogo receptor). This could be tested in combination with the cells transplants mentioned below.

      3. HLA-matched UCBMC-derived Muse cells and autologous Schwann cells. We are working with Mari Dezawa in Japan to isolate and expand Muse cells from UCBMC. UCBMC can be HLA-matched to recipients with spinal cord injury. These are pluripotent stem cells that can generate neural stem cells to replace motoneurons and interneurons in the spinal cord. We hope to combine Muse cell transplanted into the lumbosacral spinal cord with Schwann cell transplants into the ventral roots, to entice motor axons to grow into the ventral roots to re-innervate muscle. We have developed a lumbosacral spinal cord injury model in rats to test these therapies. We are hoping of course that Miami project will have good results with their Schwann cell trials so that we don't have to do phase I trials of Schwann cells to show safety.

      4. Neural stem cell lines. We have been following the trials that Neuralstem and Stem Cell Inc. have been doing. If those trials prove to be positive in chronic SCI, we will be ready and willing to take these cells to clinical trial in ChinaSCINet. These could be with the cells on their own or in combination with some of the above therapies. While I remain skeptical that these cells will survive long enough to replace neurons in the spinal cord, I think that these cells may well be an excellent source of growth factors and "come-hither" signals that could stimulate regeneration in the spinal cord as well as HLA-matched umbilical cord blood mononuclear cells.

      5. Umbilical cord lining (UCL) cells. We are working with a group in Singapore to test UCL cells that are mesenchymal stem cell like and express HLA-G, an anti-immune protein that prevents rejection. These cells have many interesting properties, including ability to repair cornea, liver, and skin. Because they express HLA-G, they are immune-privileged.

      6. Placental cells. We are working with Celgene to develop and test placental cells and other products in spinal cord injury. The placenta contains many immune-privileged stem cells and probably is the source of the stem cells in umbilical cord blood and also umbilical cord lining. These cells transplants can be tested in combination with all the other therapies, including PTEN, CSPG receptor blocker, lithium, etc.

      So, there are many therapies waiting in the wings. There are some that I haven't mentioned because we are still waiting for decisions by the companies. For example, the Nogo antibody is still "floating" and we have not yet seen the published data concerning the trial. We are of course watching the work by Kai Liu and Jerry Silver carefully. Although Liu has shown that knocking out PTEN allows many corticospinal axons to grow across the injury site, the growth of the axons is very slow (slower than 1 mm per day) and one possibility is that CSPG or other axonal growth inhibitors are slowing down the axonal growth across the injury site. So, one approach will be to combine both therapies. Much still needs to be done before a genetic therapy knocking out PTEN can be taken to trial. We are exploring other pharmaceutical means of down-regulating PTEN.

      Wise.
      Last edited by Wise Young; 17 Nov 2012, 5:07 PM.

      Comment


        It's great to hear that some collaboration may happen now that the trial network is in place. Multiple trials cannot come soon enough!

        Comment


          Wise, not sure if you can disclose or not. Here goes anyway. Are companies still viewing from the sidelines waiting? Am I delusional thinking a company could /would swoop in and at any time to make so much hard work proprietary? Is that even what happens? Is there a point in time where "business" comes in and says, "thanks for your work and your followers donations, we'll take it from here?"

          I guess what I mean is, am I looking at it all wrong by thinking there are those who are lining up, ready to stand on your shoulders and leave you and the donators who have been supporting your work (both emotionally and financially) on the outside?

          Sorry for the conspiracy theory, but I really think with so many lawyers in the world..well, enough said.
          And the truth shall set you free.

          Comment


            Originally posted by NoDecafPlz View Post
            Wise, not sure if you can disclose or not. Here goes anyway. Are companies still viewing from the sidelines waiting? Am I delusional thinking a company could /would swoop in and at any time to make so much hard work proprietary? Is that even what happens? Is there a point in time where "business" comes in and says, "thanks for your work and your followers donations, we'll take it from here?"

            I guess what I mean is, am I looking at it all wrong by thinking there are those who are lining up, ready to stand on your shoulders and leave you and the donators who have been supporting your work (both emotionally and financially) on the outside?

            Sorry for the conspiracy theory, but I really think with so many lawyers in the world..well, enough said.
            That is of course what we hope the companies will do, i.e. swoop in and support the work. Therapies cannot exist without companies because somebody has to manufacture the therapies to treat thousands or even millions of people. That is what companies do best. We, who are volunteering our time and effort, will get our satisfaction from seeing the therapies applied to and benefitting people.

            I will of course not be very happy if some company were to swoop in and use our therapies for cosmetics and not for spinal cord injury. If we have the patents, we would make sure that the license is predicated on the therapy being developed for spinal cord injury.

            Wise.

            Comment


              I am very encouraged when I read MRIs are showing white matter tracts are being laid down. I have been a RN for 31 years and have worked ,mostly with neurosurgical and neurology patients in my career. My son has been injured now for 8 years and I have to admit until I read these positive in results I had been slowly losing faith in of him ever any return, that being said we all have to be patient and to know this is great news !!

              Comment


                Wise will u start trials for lumbosacral injuries with phase2? Will u go with muse cells and schwan cells in combination for lumbosacral injuries or will add some other therapies too?

                Comment


                  If there is results with UCBMC +lithium+rehab there would be more results if we repeat the procedure once again and once again, no? Or it is only one shot therapy?

                  Comment


                    Someone ought to hook up Dr. Wise with a glass of water to sip on when he gives his next presentation. (no disrespect to Dr. Wise.)

                    Comment


                      Originally posted by Jawaid View Post
                      Wise will u start trials for lumbosacral injuries with phase2? Will u go with muse cells and schwan cells in combination for lumbosacral injuries or will add some other therapies too?
                      Jawaid, there is a lot to do before we can do trials. We are doing the animal studies and it will take a year or more before I have results. However, we are making good progress in terms of the lumbosacral model and developing a source of immune-compatible neural stem cells for transplantation. As soon as we have confirmed data, I will post. Wise.

                      Comment


                        Originally posted by okwjoe View Post
                        I am very encouraged when I read MRIs are showing white matter tracts are being laid down. I have been a RN for 31 years and have worked ,mostly with neurosurgical and neurology patients in my career. My son has been injured now for 8 years and I have to admit until I read these positive in results I had been slowly losing faith in of him ever any return, that being said we all have to be patient and to know this is great news !!
                        Joe,

                        We were excited to see the DTI images suggesting regrowth of white matter in the spinal cord. I hope of course that we will see neurological function associated with the growth, suggesting that the growing axons are making synaptic connections. We are also committed to continue testing the most promising therapies in clinical trials, as quickly and efficiently as possible.

                        Wise.

                        Comment


                          Originally posted by Ruben View Post
                          If there is results with UCBMC +lithium+rehab there would be more results if we repeat the procedure once again and once again, no? Or it is only one shot therapy?
                          Good question. We have long considered doing the procedure again. It is logical that if it works once, perhaps multiple transplants will be better. However, we need to prove that doing it once is safe and beneficial. We should also be testing multiple treatments in animals as well.

                          Wise.

                          Comment


                            Originally posted by okwjoe View Post
                            I am very encouraged when I read MRIs are showing white matter tracts are being laid down. I have been a RN for 31 years and have worked ,mostly with neurosurgical and neurology patients in my career. My son has been injured now for 8 years and I have to admit until I read these positive in results I had been slowly losing faith in of him ever any return, that being said we all have to be patient and to know this is great news !!
                            okwjoe,

                            if you have time, I would suggest you to watch again Wise's presentation at the Bedford workshop, then write down carefully all Wise saies about the DTIs, and think about it.
                            The devil is in the details.

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

                            Comment


                              Paolo, let him to do what he is doing. Without alchemists we wouldn't have the Chemistry.

                              Comment


                                Originally posted by kivi66 View Post
                                Paolo, let him to do what he is doing. Without alchemists we wouldn't have the Chemistry.
                                Kivi, I understand what you say, in fact I have been nice with Wise until last June when IMO informations have been presented in a way that was too easily "misunderstandable".
                                I support ChinaSCINet and SCINetUSA as long as things are presented clearly, consistently and supported by facts. One DTI showing "regeneration" is good, but keep in mind also the DTIs showing the spinal cord out of the canal.
                                The margin for error with DTI is significant, so one DTI showing "regeneration" could easily be a problem with the DTI.
                                If we had 10 patients with a DTI showing some "regeneration" we could have something significant.
                                Unfortunatly the patients done in Kunming don't have DTI images.

                                I am glad that at the end of the presentation Wise said he expect no one is going to believe what he had presented.

                                So, probably, instead of having a clinical trial network with 25 centers non very well equipped it is better to have one center well equipped (with all kinds of electrophisiology, DTI etc.) and accept patients from all over the world.

                                I'll be nicer with Wise in the future, but he has to present stuff in a credible way, so that when someone tells us that a cure for SCI is not possible we have strong arguments to support that SCI can become curable by using the info he share with us.

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

                                Comment

                                Working...
                                X