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Thread: Looking forward-- Dr. Young

  1. #1

    Looking forward-- Dr. Young

    Not to undermine the clinical trials you are conducting now, I like many others, wish you the utmost success in seeing positive results. I sufffer from chronic pain, so finding a treatment for that bain of my existence, would be a major accompllishment from my perspective.

    Anyway, if you didn't have to consider all the ethical and political bs that surrounds embryonic stem cells(not that they would be your top choice} what combination therapy would you try if you weren't confined by financial restraints and other restrictions, like the extensive and redundant research needed to satisfy the FDA?

    As a community, is there any thing we can do collectively to facilitate the timeline, so we can make it happen sooner rather than later? What kind of advocacy can we harness to complement other cure oriented orginizations. Basically what I am saying is, how can we push for more...NOW?

  2. #2
    Hey Bibly, good to see you again.

    Dr. Young posted this a while back so I figured I repost until he gets a chance to answer.

    Also, i'm attaching an abstract of this study-

    Efficacy and safety of lithium carbonate treatment of chronic
    spinal cord injuries: a double-blind, randomized,
    placebo-controlled clinical trial


    The aim of this study was to investigate the efficacy of lithium on chronic spinal cord injury patients. Surprisingly, they found that lithium greatly reduced neuropathic pain. A trial is now being planned in Hong Kong to test this blindly.
    (starts on p. 144, Secondary outcomes)


    Future Trials-

    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.
    Attached Images Attached Images
    Last edited by Jim; 01-17-2013 at 04:41 PM.

  3. #3
    Thanks, Jim. Hope all is well. I wonder if Dr Young changed his mind about number 4. The survival of cells for a long period of time happens...at least in the ALS trials and in animal studies.

  4. #4
    I was hoping he had an answer that might be the Eureka Treatment. The one he would intiate tomorrow if he had the resources.

  5. #5
    when are you going to ask permission to the FDA?
    JustaDollarPlease.org

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