Thread: ChinaSCINet Update

  1. #1271
    Im sorry, but I am majorly confused. The talk about this trial is in so many directions that I dont know whats what. Not to mention Wise Young saying they arent showing improved motor or sensory scores. But in one video says that a patient could feel that his leg was fractured and in another video says that a patient complained of increased neuropathic pain but the improved return was worth it.
    Sorry but I think this is too unclear and confuse able. And that might not be good for raising money.

  2. #1272
    Quote Originally Posted by Barrington314mx View Post
    Im sorry, but I am majorly confused. The talk about this trial is in so many directions that I dont know whats what. Not to mention Wise Young saying they arent showing improved motor or sensory scores. But in one video says that a patient could feel that his leg was fractured and in another video says that a patient complained of increased neuropathic pain but the improved return was worth it.
    Sorry but I think this is too unclear and confuse able. And that might not be good for raising money.
    In the very first clinical trial done around 2 years ago in Hong Kong, 16 people were given a low dose of umbilical cord stem cells. Some of these people have shown sensory improvement of one or two segmental levels (this returned over a long period of time). These subjects received no physical therapy, MP, or lithium.

    In the more recent trials (6-12 months ago) the subjects received higher levels of stem cells + MP and physical therapy. There may be indications some subjects are walking without yet getting sensation or voluntary movement back.

    We might conclude from this info that return varies. A possible outcome of a subject getting UCBMC+physical therapy might be that they start walking in six months and then in two years begin to feel their feet. People are improving but it takes time. The procedure isn't an instant miracle cure-all.

    I understand how you feel about being confused sometimes. I think it is probably hard for Wise, knowing everything he knows about the actual results of the trials, to read posts by people on carecure dealing with deep SCI-related depression (some to the point of being suicidal) and not feel some moral obligation to let them know that there is hope. So what he gives are purposely-not-always-completely-clear answers that amount to "we are getting there, don't give up yet!" Some people get mad precisely because the answers not crystal clear. I would bet though most people here are at least a tiny bit excited by the message, even if they don't completely understand all the words.

    Hopefully, collection of the 6 month follow-up data of the June subjects is going super smoothly... then there will be good, solid info to share by the end of the year.

  3. #1273
    Quote Originally Posted by crabbyshark View Post

    We might conclude from this info that return varies. A possible outcome of a subject getting UCBMC+physical therapy might be that they start walking in six months and then in two years begin to feel their feet. People are improving but it takes time. The procedure isn't an instant miracle cure-all.
    Im fine with that. Where do i sign up.
    Seriously, thats the best thing we would have to date. So i would hope that even if thats the case, that itll be enough to move it forward.

    But thanks for your explanation. Im definitely not mad at anyone or anything. I took everything that Wise has said in his videos as good news. But then I come on here and read not so positive posts and start to wonder if i miss interpreted what he had said in the videos.

  4. #1274
    Crabbyshark,

    Thank you for doing such a good job explaining the ChinaSCINet results. Let me correct or more fully characterize a few findings:
    1. The two Hong Kong centers transplanted cells into 8 subjects, only 4 µliters x 4 and 8 µliter x 4 injections into the spinal cord and did not test the 16 µliter x 4, of 16 µliter x4 and MP, or 16 µliter x 4 with MP and 6 weeks of lithium.
    2. The Kunming center transplanted cells into 20 subjects, including the 4, 8, and 16 µliters x 4 injections, the 16 µliters x 4 with MP, and the 16 µliter x 4 with MP and a 6-week course of lithium.
    3. Of the 8 subjects studied in Hong Kong, only 5 had good enough MRI to allow the DTI to show the white matter. Of the 5, two subjects showed evidence of white matter regrowth across the injury site. Unfortunately, in these subjects, we did not find a correlation with neurological function. We are continuing to follow these subjects.
    4. Of the 20 subjects studied in Hong Kong, we have not yet analyzed the 6 months data. Based 6-week and 3-month data, we are seeing improvements in walking scores without improvements in ASIA motor or sensory scores.


    I hasten to point out that this was a talk that was addressed to scientific colleagues at a workshop on the subject of obstacles to clinical trials. I was discussing two findings in our trials that I felt needed discussion by the scientists in the audience. If this talk were for the spinal cord injury community, I would have spent a lot more time explaining why regeneration is likely to take years and that axons have to grow upward all the way from the injury site to the brainstem to restore sensation and downward all the way from the injury site to the lumbosacral spinal cord to restore voluntary leg movements. Also, axons don't have to restore voluntary movements in the legs in order to restore walking motions. I did not cover these issues because the audience that I was speaking to, including the top scientists in the field, know these concepts well.

    Let me describe our interpretation of the two major findings that I presented to the scientists.

    First, we found that evidence of white matter regrowth in 2 of 5 subjects after UCMBC transplants, not just across the gap but apparently long distances both up and down the spinal cord. All ASIA A subjects showed a white matter gap before treatment. None had shown white matter growth across the gap before cell transplantation. The growth does not seem to correspond with motor and sensory scores in the subjects. We believe that this may be because the growing fibers have not yet reached their targets, i.e. have not connected with neurons in the brainstem that would be necessary for sensory improvement or in the lumbosacral spinal cord for voluntary activation of the leg muscles.

    Second, in Kunming, while some subjects are taking steps, they are not showing improvements in their motor or sensory scores. We believe that this is occurring because some growing fibers have made connections with the central pattern generator and this is what is activating the walking activity without improving motor or sensory scores. Incidentally, this is not surprising. Most people who recover walking and even ability to run long distances in marathons, i.e. so-called walking quads or paras, don't have normal motor or sensory scores in the legs. I emphasized that these results are very early and that perhaps motor and sensory scores will show more change on later examinations.

    Because of the widespread misunderstanding of what was presented, I am reconsidering presenting any more data from these trials until the trials are complete. People are jumping to unwarranted conclusions.

    Wise.

    P.S. I moved some of the posts to the Members Only Forum because they are unrelated to ChinaSCInet, which is what this topic is about.
    Last edited by Wise Young; 11-30-2012 at 04:52 AM.

  5. #1275
    Quote Originally Posted by beuty View Post
    have you considered autologous stem cells transplantation (mesenchymal, hematopoietic etc ...)
    Yes, we have considered and are considering autologous cells. These include of course autologous OEG cells from the nasal mucosa and autologous bone marrow cells. Wise.

  6. #1276
    Quote Originally Posted by Barrington314mx View Post
    Im sorry, but I am majorly confused. The talk about this trial is in so many directions that I dont know whats what. Not to mention Wise Young saying they arent showing improved motor or sensory scores. But in one video says that a patient could feel that his leg was fractured and in another video says that a patient complained of increased neuropathic pain but the improved return was worth it.
    Sorry but I think this is too unclear and confuse able. And that might not be good for raising money.
    I am so sorry that you feel confused. Results from clinical trials are often confusing because they contain new information that change the way that we think about spinal cord injury. People are also forming expectations of these trials that are unfair to the therapy. These trials were intended to demonstrate safety and are not sufficiently powered to show efficacy but people are expecting miracles. Let me explain what I mean by this.

    We believe that the best results will come from the highest safe dose of umbilical cord blood cells combined with a single bolus of methylprednisolone and a 6-week course of lithium. Methylprednisolone (MP) should allow more of the transplanted cells to survive. A 6-week course of lithium shouldcause the transplanted cells to proliferate and also to produce growth factors that stimulate regeneration. Lithium has also been reported to stimulate regeneration of the spinal cord.

    However, we did not know the safe dose of umbilical cord blood mononuclear cell transplants. That was why we started with 4-µliter injections and then progressed to 8 µliters and then to 16 µliters. In Hong Kong, we only did the 4- and 8-µliter injections and never got to the groups where we would give methylprednisolone or lithium.

    Despite this, we saw remarkable white matter growth in the patients that received transplants. We saw clear gaps in all other patients before treatment. Of course this finding needs to be confirmed in many more subjects and confirmed by other measures of regeneration but these findings are amazing. Many scientists are excited by these results.

    The slow growth of white matter was also expected but the extent of the growth was surprising. Axons grow no faster than a mm a day, and probably slower and the fact that we did not see the growth until 6-12 months after transplantation is not surprising. We were shocked by the amount of white matter growth. The MRI/DTI probably cannot detect fiber tracts that are less than a millimeter in diameter and I think that many of the white matter growth that we saw were several mm thick.

    At 6 months, one of the subjects showed growth across the injury site and, to our enormous surprise, the growth seemed to have retracted at 12 months and then grew back at 18 months. This was shocking although, in retrospect, perhaps we should not be surprised that white matter can both grow forward and retract. It suggests much greater plasticity of white matter than we could have imagined. Of course, these findings must be replicated on larger series and confirmed with other methods of assessing white matter growth. If confirmed and the regrowth leads to functional improvement, this would be the first demonstration of regeneration in human spinal cord injury.

    Finally, I don't know why Paolo and others don't understand that people can walk without changes in motor and sensory scores. I have been posting about the central pattern generator for over 15 years here on CareCure. Many people who recover walking after spinal cord injury cannot voluntarily move their legs or feel their legs as well as you would expect from their walking. We should also remember that this is very early in the trial and we may well see improved motor and sensory scores at 2 or even 3 years. The axons have to grow a long distance before they can restore function. I have been posting about how slow regeneration is for many years here.

    So, I am actually quite reassured and excited by these results. The DTI images indicate that umbilical cord blood mononuclear cell transplants are causing regrowth of long tracts in the spinal cord, both ascending and descending. The fact that we are seing some early walking improvement although no motor or sensory score change is reassuring as well. If the results had shown earlier sensory and motor score recovery with no DTI evidence of white matter regrowth, it would have suggested that the treatment caused sprouting of surviving tracts that the MRI/DTI could not detect. This is less exciting than the finding that UCBMC are stimulating regeneration.

    I am very anxious to see the last group of four patients transplanted with 16 µliters coupled with a bolus dose of methylprednsiolone and a 6-week course of lithium. We won't have the 6-month results on these patients until December. My staff will be in Kunming next week to help them enter the data. Through the entire month of November, the nurses have been flying or travelling to the patients' homes to do the examinations.

    Wise.

  7. #1277
    Dr. Young ,

    Hi, Thank you so much for your time and important and great work that you are doing ; as i said before , i believe this community may never find a better friend than you .The amount of time and energy that you have been spending on these projects are unbelieveable . I indeed appreciate everything that you do to help and find a solution and cure for spinal cord injury . take care.
    All the best
    Last edited by kz; 11-29-2012 at 09:38 AM.

  8. #1278
    Dr. Young ,

    Hi, Thank you so much for your time and important and great work that you are doing ; as i said before , i believe this community may never find a better friend than you .The amount of time and energy that you have been spending on these projects are unbelieveable . I indeed appreciate everything that you do to help and find a solution and cure for spinal cord injury . take care.

    Ditto, thank you, Dr. Wise!!!

  9. #1279
    Dr. Young, thank you for all the information you have just shared! I know it’s certainly gives me hope to read what you’ve written and know we have someone like you on our side.

    I don’t blame you for reconsidering presenting any more data about the trials until they're complete. I think people have been completely unreasonable with their expectations, and need to take a step back and realize this treatment was never intended to be the miracle cure, but a way to test the safety and effiancy of a treatment that is indicating some real possibilities.

    This isn’t the cure yet folks but one very important step along the journey of getting us there.
    I am the Quad in Quadomated. Come read about Life and Technology through the Eyes of a Quad
    http://www.Quadomated.com/

  10. #1280
    Quote Originally Posted by Wise Young View Post
    ..
    Finally, I don't know why Paolo and others don't understand that people can walk without changes in motor and sensory scores. I have been posting about the central pattern generator for over 15 years here on CareCure. Many people who recover walking after spinal cord injury cannot voluntarily move their legs or feel their legs as well as you would expect from their walking.

    ...
    Wise,

    it's just that since I have no voluntary movement in my legs and supposing my CPG works, I can't understand how I can tell my legs to start moving when I want walk and how do I stop them when I want to stop. Or how can I go right and/or left if I let's say have to avoind an obstacle?

    Can you show me a video of somemone walking who has no voluntary movements of the legs?

    PatricK Rummerfield is not a good example as he has voluntary movements. I know him.

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

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