Thread: ChinaSCINet Update

  1. #1641
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    Quote Originally Posted by Wise Young View Post
    CAS,

    Phase III trials lead to regulatory approval. Phase IV trials are post-approval, to look for long-term complications, etc. We are working as hard as we can to get the phase III started and completed before 2020. Barring any complications (such as lack of funding), we should know the whether the treatment is effective and safe in 2015.

    That phase II trials have yielded several surprising findings. The first is that MRI/DTI images are showing evidence fiber bundles growing across the injury site, suggesting of regeneration and that this grown is occurring a 6-12 months after transplantation of the cells. The second is that a majority of the transplanted subjects are showing improvements in locomotor scores without improvement in motor and sensory scores, at least at 6 months and in some cases at 12 months.

    We would like to confirm these findings as soon as possible in formal phase III randomized and controlled clinical trials. It is important to find out whether or not we see fiber bundles growing in the spinal cord when we do not transplant cells. Likewise, we need to find out whether the subjects do not show this kind of walking improvement without cell transplantation. Finally, of course, we are hoping that the subjects will show motor and sensory score improvements eventually.

    Wise.
    thanks

  2. #1642
    Moved to another thread

  3. #1643
    Assuming the funding for phase III works out, how would the subjects be selected? Would it be done by the individual hospital(s)? Mainly, could a US citizen participate?

    I know that getting some of the patients to return for interval checkups was an issue in the past and I'd think that people committing would be preferable to those that would get the treatment and disappear.

  4. #1644
    Quote Originally Posted by MarcT View Post
    Assuming the funding for phase III works out, how would the subjects be selected? Would it be done by the individual hospital(s)? Mainly, could a US citizen participate?

    I know that getting some of the patients to return for interval checkups was an issue in the past and I'd think that people committing would be preferable to those that would get the treatment and disappear.
    MarcT,

    Subjects for trials are always chosen by the principal investigator of the participating center, according to the inclusion and exclusion criteria of the clinical trial protocol. They are not selected by the sponsors or organizers of the trials.

    Whether a U.S. citizen can participate depends on the centers. About half of our hospitals are military hospitals that do not take foreigners, although they can take Chinese citizens. However, the private hospitals can take foreign patients but the principal investigator has to be convinced that the patient will participate in the trial and return for followup.

    We are now considering randomizing the subjects in the CN103 (phase III trial in China) to a full year of locomotor training. This will be a subject that the principal investigators will be discussing in our upcoming Xi'an meeting. If we are offering this, we have decide what to do with subjects who don't want to spend a full year training.

    You should be aware that there are significant language barriers in China (i.e. most of the hospitals do not have doctors or nurses who can speak English well enough to communicate with foreigners) and also we do not have funds to pay for the travel of overseas patients to travel to China. We will be doing the trials in the United States although I suspect that we will not be able to implement the 6:6:6 program here to the same extent as in China.

    Wise.

  5. #1645
    Hi! Thanks so much for contributing to this discussion. I like the concept of not only indicating the walking time but also measuring the walking distance.

    Wise.


    Quote Originally Posted by mamadavid View Post
    There are several paras at the centre just now. Two of them are young boys (9 and 11 years old). They have been there probably 8 or 9 months. Neither was in the clinical trials. Both had surgery -- in one case it was untethering surgery to reduce spasticity and in the other it was more complex -- I can't give any precise information about it. One of the boys is at Stage IV now -- as I remember, when we arrived he was just beginning to stand and take assisted steps. The other boy is at Stage III now (I think). Two other paras came a couple of months ago -- one is the man shown walking with the walker in the video Wise posted. He was in the clinical trial and came back to continue his walking training. I'm not sure what the history of the other man is -- how long ago he was injured, whether or not he has had surgery. I believe he is at Stage III now. The tetraplegics are my son (C5) and the woman Wise mentioned as having the most severely damaged spinal cord he had ever seen. She does a lot of walking with the wheeled walker -- I think about 600 metres each day. This is wonderful considering that when I first met her last March just after her surgery (again, untethering to relieve spasticity and pain) she couldn't move or feel anything below the injury site and could barely raise her head off the bed.
    One girl with a cauda equina injury left shortly after we arrived -- walking very well with crutches. Another girl left about a month ago. She had a C6 central cord injury I believe. She got to the stage where she could walk just with someone walking next to her and holding her arm to give her support. I believe she came to Kunming about a year after injury but I don't know if she had surgery.
    We rent an apartment near the hospital -- it's about a 15 minute walk / wheel, no traffic. My son brought his nurse from Hong Kong to do the usual caregiving tasks -- showering, dressing, cathing, etc. The other patients hire people locally -- they have no formal training but some have mastered the basics pretty well. The hospital nurses cannot provide routine care, but they are always willing to help when needed.
    My son plans to stay here indefinitely. He is making steady (though slow) progress and having been through the rehab mill in various places we feel this is the best there is. He also loves the staff and the other patients. It's such a great atmosphere and the doctors and physiotherapists are always telling us that they care about each patient as if he or she were their own child.
    As it's Chinese New Year most everyone including Dr Zhu is away. She'll be back on Monday and I'll tell her about the recent interest in her treatment among readers of this forum. I also was away for three weeks so I don't know the latest on when the new centre will be ready to open. But I'll do my best to answer questions people might have about the programme.

  6. #1646
    Quote Originally Posted by Wise Young View Post
    Eric,

    I am not sure what you are looking for but I clearly don't have confidence in the limited data that we have to date. I have already said that we should not expect much functional return until more than a year after treatment. We don't even have all the 12 month data.

    Wise.
    when I speak of confidence im talking about your confidence in the longterm outcome of the trial.

  7. #1647
    Thanks for sharing Dr Wise. Would you be so kind to share the info on the principal investigators when the time comes? So we can contact them and see I we fit the criteria?

    Thanks,

    Rene

  8. #1648
    Quote Originally Posted by Wise Young View Post
    MarcT,

    We will be doing the trials in the United States although I suspect that we will not be able to implement the 6:6:6 program here to the same extent as in China.

    Wise.
    How far behind to you suspect the phase 3 in the US will be behind the stage 3 in China?
    Lets assume China completes all processes necessary to get this therapy/treatment to market, would US citizens be able to get treated in China if it were self paid?

  9. #1649
    Senior Member Imight's Avatar
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    Quote Originally Posted by mamadavid View Post
    We rent an apartment near the hospital -- it's about a 15 minute walk / wheel, no traffic. My son brought his nurse from Hong Kong to do the usual caregiving tasks -- showering, dressing, cathing, etc. The other patients hire people locally -- they have no formal training but some have mastered the basics pretty well. The hospital nurses cannot provide routine care, but they are always willing to help when needed.
    My son plans to stay here indefinitely. He is making steady (though slow) progress and having been through the rehab mill in various places we feel this is the best there is. He also loves the staff and the other patients. It's such a great atmosphere and the doctors and physiotherapists are always telling us that they care about each patient as if he or she were their own child.
    As it's Chinese New Year most everyone including Dr Zhu is away. She'll be back on Monday and I'll tell her about the recent interest in her treatment among readers of this forum. I also was away for three weeks so I don't know the latest on when the new centre will be ready to open. But I'll do my best to answer questions people might have about the programme.
    Fantastic!

    I am also away for chinese new year, I had to have my gallbladder removed last week, but I should also be back in 3 weeks. After my accident I had surgery - decompression (C7-T1). I can move and feel all of my muscles, I'm an Asia C and can move most of them against gravity and some of them against weight resistance. My problem is spasticity. I think if I had less spasticity I would walk A LOT better, unlike most walkers they don't help me walk, they get in the way more than anything. They're so tight it feels like I'm walking in tar sometimes. Meds make me drowsy and lazy. If I didn't have the drowsy effect and could find something to reduce my tight muscles, I could strengthen my muscles with isolated lifting. My spasticity disrupts the fluidity of my gait.


    What is untethered surgery and do they perform them on incompletes? is it safe? how beneficial is it and are their any possible complications like MORE spasticity?

    I think I'm done with surgeries, esp ones near my cord (unless they have to do with stem cells but I'm curious what this is and how it's really benefited people there and their walking.

  10. #1650
    Quote Originally Posted by ResidentBio View Post
    Thanks for sharing Dr Wise. Would you be so kind to share the info on the principal investigators when the time comes? So we can contact them and see I we fit the criteria?

    Thanks,

    Rene
    Rene, I will do so here on CareCure and also on http://clinicaltrials.gov when the trial has been granted approval for the FDA.

    Wise.

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