Thread: ChinaSCINet Update

  1. #1491
    Senior Member lunasicc42's Avatar
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    not directed at anyone, but.... General disappointment
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  2. #1492
    Senior Member Moe's Avatar
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    Quote Originally Posted by Wise Young View Post
    ay2012, I simply have not decided.

    Let me review what happened. I had earlier provided general comments about the results when I announced that we will go ahead to do Phase III trials because our phase I/II trials indicate that the therapy is safe and some patients have shown improved locomotor function. This was greeted with great interest by many people and disbelief by some people, who went as far as to suggest that I am providing confusing information in order to raise more money for the trials.

    Last month, I was giving a talk to other scientists in the New Bedford workshop about the obstacles and lessons we have learned from clinical trials. I pointed out two interesting findings in our trial, i.e. that we are seeing white matter regrowth in some patients and that improved locomotor function can occur without significant changes in motor and sensory scores. This led to a spirited discussion that I hope helped the community understand some of the mechanisms of recovery from regeneration.

    I have stated many times that I will not provide detailed trial data and that people would have to wait until publication for such data. In addition, I also said many times that I did not believe that even the 6-month data would be sufficient to show that umbilical cord blood cell transplants is effective or not. Despite my repeated assertions that it is too early to say anything definitive about efficacy of umbilical cord blood transplants, many people have been jumping to unwarranted conclusions that umbilical cord blood mononuclear cell transplants are not effective.

    Some people have dismissed the therapy because people are not walking at 6-12 weeks. So, clearly, releasing the 6-month data can lead to misconceptions by the community. At the present, I am unsure that the benefits of releasing the 6-month data are sufficient to counter the misconceptions.

    Wise.
    Very understandable.
    Thank you Dr. Wise & ChinaSCINet for all your hard work.
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  3. #1493
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    Thanks for the reply & info Dr. Young.
    C4/5 incomplete, 17 years since injury

    "The trick is in what one emphasizes. We either make ourselves miserable, or we make ourselves happy. The amount of work is the same.” - Carlos Castaneda

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  4. #1494
    Quote Originally Posted by Wise Young View Post
    Paolo,

    Penetrating wounds of the spinal cord are relatively rare. For example, we did not see any case of a penetrating or transecting wound of the spinal cord in 41 ASIA A patients that we transplanted cells into so far, 28 of which are chronic and 13 were subacute. All the spinal cord appear intact from the outside. We inject the cells into the spinal cord surrounding the injury site, into the dorsal root entry zones above and below the injury site.

    Yes, Liu, et al. 2010 did assess regeneration in "acute" spinal cord injury, in the sense that the rats already had PTEN deleted before they were injured. On the other hand, the regeneration across the injury site took a long time. Kai Liu had to wait 6-8 weeks before he saw the axons grow across the injury site. In rat and mouse time, each week is equal to about a month. If a glial scar formed, it should have been there within 2-3 weeks.

    It seems to me that the burden of proof should lie on those people claiming that there is a "scar" that obstructs axonal growth rather than on people who don't see any scar there and are finding axons that grow into the contusion site. If a scar is there and is truly blocking axonal growth in contused spinal cords, why are we seeing so many axons crossing the injury site in the chronically injured spinal cord?

    Wise.
    sorry I posted this in the other thread but it belongs here:
    Subacute? Which trial is this? I was under the impression that of the patients in both the Hong Kong and Kunming trials were chronics....I went back and saw you mention these subacute patients a few times and also checked clinicaltrials.gov which seems to have a separate trial for acutes and subacutes (NCT01471613)... Is it right to assume then that you were talking about the improved locomotor, sensory, motor scores in terms of chronic patients? If not, are the subacutes getting the intradural decompression? I'm sorry if you've clarified before but suddenly I'm very confused....and I think it would just be nice to know if your personal observations from before were from chronics or subacutes. Thanks!
    So, I just would like to know (if you're aware) whether these improvements, in sensory, motor and locomotor scores are from chronics or subacute? I'm assuming the former if these observations form the basis to move forward with the Phase III trials and sorry to labour the point but I think it's pretty relevant...

  5. #1495
    ay2012, if you read back, all the info is in this thread.

  6. #1496
    Quote Originally Posted by Wise Young View Post
    Jerry,


    At 6 months, we are seeing more and better improvements of both motor and sensory scores, as well as locomotor scores.

    Wise.
    This is good news,

  7. #1497
    Quote Originally Posted by Wise Young View Post
    Paolo,

    Yes, cutting into the spinal cord will damage some tissue. In the early stages, a contused spinal cord is filled with dead tissue that is under pressure. The pressure results with the breakdown of the blood brain barrier and swelling of cells at the injury site. If you cut the spinal cord too early after injury, the spinal cord will "mushroom" out of the opening and the results may even be worse. Reginald Allen in 1911 and 1914 reported that a myelotomy and removal of necrotic tissues from a contused cord will restore function in dogs. Several attempts were made to test this claim in humans in the 1970's but these were usually done shortly at 8-24 hours after injury. We have tried this in animals and found that a myelotomy done during the first 24 hours will allow the spinal cord to swell out of the dura so that we cannot stitch it close. To see the beneficial effects, we must go in at a week or longer, when the spinal cord is not under pressure. When we do a myelotomy at 10 days, the spinal cord does not swell out of the dural opening and the animals show less tissue damage when we look at the spinal cord 6 weeks later.

    Has this animal study been published?

    I don't know where you got the "understanding" that more than 50% of human spinal cord injuries are much worse than the typical spinal contusions done in the laboratory. In fact, over 64% of spinal cord injuries admitted to hospital in the U.S. are incomplete injuries (ASIA B, C, D).

    That confirms what I said, thank you Wise.
    In fact with the contusion models used in labs currently animals recover some movements usually above BBB 10 which makes the animals like an ASIA C human. That does not happens in real life with all human SCIs.

    Of those with "complete" spinal cord injuries, almost all involve contusions or crush without penetration of the dura. In ChinaSCINet, I have now seen chronic injured spinal cords in the operating room.

    I am happy you are finally seeing human chronic spinal cords (I am surprised to learn you have not seen human spinal cords before), but remeber these are selected SCI according to the inclusion criteria as you specify below which exclude severe SCI etc., so they do not rapresent the SCI population.


    You would be astonished by how intact the spinal cord looks. The concept of cutting a chunk of that spinal cord out is, in my opinion, is totally unjustified.

    We are currently testing the hypothesis that umbilical cord blood cells injected into the surrounding cord will migrate into the injury site and produce a bridge of cells. These are of course phase II studies assessing feasibility and safety of the injections. Our studies have shown that the procedure is feasible and safe, that the cells seem to allow bundles of fibers to grow across the injury site and possibly go long distances up and down the spinal cord, and that some of the subjects are recovering locomotor function at 6 or more months after treatment.

    I don't believe you here, but I hope you'll present scientific evidence, so that I will change my mind.

    We are not using any biomaterials in our chronic spinal cord injury study. However, there may be an opportunity to use some biomaterials in subacute spinal cord injury. Several groups have approached us with a variety of biomaterials for this purpose. We are still evaluating these materials before we make a decision.

    That's interesting you never said before, that I remember, that you are evaluating biomaterials.

    As I said, we are planning a phase III trial of the lateral myelotomy treatment of subacute spinal cord injury in ChinaSCIN
    et. If this trial shows that the myelotomy is beneficial, this will open up an opportunity to do a multicenter trial where some type of biomaterial and cells can be placed into the cavity opened up by the myelotomy.

    I do not believe that umbilical cord blood mononuclear cells (UCBMC) will be beneficial for all types of spinal cord injuries. As I have already indicated, this therapy is designed to improve long tract regeneration and may not be effective for some types of spinal cord injuries.
    For example, UCBMC+lithium, without neuronal replacement therapy, is not likely to help people with lower lumbosacral injuries where substantial gray matter have been damaged. That is why we are now developing a lumbosacral spinal cord injury model and testing neural stem cells in that model with different approaches to attracting axons to grow into the ventral roots.

    On the other hand, I think that the method that we have developed for injecting cells into the spinal cord above and below the injury site will be useful even for severely injured spinal cords, as long as there is no separation of the two ends of the cord.

    Does that mean that if there is separation there is no hope in your opinion?

    We excluded patients who have long lesion sites where there is a gap of white matter than extends over two segments. This is because we don't want to do a laminectomy that is longer than 2 segments.

    I suspect also because you consider harder to see some recovery in these cases.

    We have also excluded patients that have T11 and lower injuries or C4 and higher injuries. So, our trial will not shed any light on the efficacy of the therapy for those conditions.

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

  8. #1498
    Quote Originally Posted by Wise Young View Post

    Quote:
    Originally Posted by ay2012
    Dr. Young, I know you think some people hang onto little things you say and sometimes misconstrue them, and I don't want to put words in your mouth or blow things out of proportion...but if this is what you really meant to say that is great news. You had mentioned both slight sensory and moderate locomotor recovery before, but improved motor scores would suggest controlled movements of muscles...fantastic!!

    ay2012, please don't over-read. In the immediately following sentence, I stated
    Quote:
    In my opinion, it is still too early to tell and we will need to do the phase III to come up with convincing results that the UCBMC with or without lithium is restoring function.


    Wise.
    Wise,

    in my opinion you are being unfair with ay2012, he is just reading with common sense. Perhaps you should be more careful not to post misunderstandable info and contradicting info.

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

  9. #1499
    Originally Posted by Wise Young
    Jerry,


    At 6 months, we are seeing more and better improvements of both motor and sensory scores, as well as locomotor scores.

    Wise.



    Quote Originally Posted by beuty View Post

    This is good news,
    beuty,

    please don't over-read. Wise in the immediately following sentence, stated
    Quote:
    In my opinion, it is still too early to tell and we will need to do the phase III to come up with convincing results that the UCBMC with or without lithium is restoring function.

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

  10. #1500
    Quote Originally Posted by Wise Young View Post
    I post late either from jet lag or from being on the other side of the world. But seriously, I frequently stay up late because I am skyping with my colleagues concerning the clinical trials. A myriad decisions are associated with clinical trials. I am thankful for Boeing 777's and Skype. They allow me to fly directly to China from Newark and to communicate with my staff in Hong Kong in real time. Without these two developments, I think that ChinaSCINet would not have been possible. To avoid criticism, I disclose that I have no stock and have received no consulting fees from United or Microsoft, the owners respectively of the Boeing 777's and Skye. Wise.
    I can't imagine how exhausting your schedule is Doc, just remember to take care of yourself through it all.


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