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Thread: This is must see tonight.

  1. #21
    What do you guys expect?? I think even when they are stepping with aids its a big one......at least for me. And I dont think either that they are walking around like nothing.....

    1.its a TRIAL
    2.its kind of a short time frame when they are really ASIA A chronics

    so this is still big IMO

  2. #22
    Quote Originally Posted by KK11 View Post
    What do you guys expect?? I think even when they are stepping with aids its a big one......at least for me. And I dont think either that they are walking around like nothing.....

    1.its a TRIAL
    2.its kind of a short time frame when they are really ASIA A chronics

    so this is still big IMO
    Wise told me first time about people walking in China several years ago when I first met him.
    I have never seen one of them yet nor minimally credible data.

    Just stay tuned and in a while the reality will become visible, good or bad.

    Paolo

  3. #23
    I agree, we have to be careful using the term 'walking'. People will tend to assume the person is back to normal.

    I've been to the Army Hospital in Kunming and have seen the patients walking with assistance, and that was before this trial. Have also seen videos of patients in the current trial walking with different levels of assistance.

  4. #24
    Quote Originally Posted by Jim View Post
    All of the patients are chronic ASIA A. 15/20 patients have reached at least Kunming Level 4 which is stepping. Others are doing even better.
    Well but then something is wrong when you say that the patients are chronic ASIA A. You said they walked already before the trial. I never saw ASIA A patients walk

  5. #25
    All the patients in the trial are chronic ASIA A.

    Some of the patients I saw while there 3 years ago were acute, don't know what their ASIA levels were.

  6. #26
    Quote Originally Posted by ay2012 View Post
    I agree. And I don't mean in any way to denigrate what even therapeutic stepping could mean for ASIA A's with little to no muscle in their lower extremities: but we/you guys should be careful what we call walking. Hopefully assisted stepping is one stop on the road to unassisted walking...
    No patient was walking before treatment. They range from 4-20 years after injury, mean 13 years. 15 of 20 subjects are taking steps and walking at the KLS IV level. They are walking with the help of a rolling frame and somebody with a cloth rope pulling lightly from the back of each leg to prevent the knees from buckling in the stance phase. These 15 subjects reached KLS IV by 6-12 months after treatment.

    It is not true that they have "little to no muscle in their lower extremities". They have muscles and the muscles are moving their legs to take the steps. Many are walking 6 hours a day and many hundreds of meters. This is minimally assisted stepping. Nobody is pushing the legs to make them take steps.

    They are wearing no braces except for stretchy band placed in a figure 8 around the ankles and feet to reduce foot drag during walking. At the KLS IV level, the subjects are walking with the help of a rolling frame and somebody walking behind them with ropes to prevent their knees buckling. When walking long distances and times, the subject's quadriceps become weak and the legs may buckle. The ropes prevent that from happening.

    Two of the subjects are walking better than KLS IV, i.e. one is walking at KLS V (using the walking frame without somebody using ropes to stabilize the knees during stance phase), and one is walking at KLS VI level (using a four-point walker without anybody helping). We don't yet have one year followups on 5 of the subjects.

    Wise.

  7. #27
    Quote Originally Posted by Wise Young View Post
    No patient was walking before treatment. They range from 4-20 years after injury, mean 13 years. 15 of 20 subjects are taking steps and walking at the KLS IV level. They are walking with the help of a rolling frame and somebody with a cloth rope pulling lightly from the back of each leg to prevent the knees from buckling in the stance phase. These 15 subjects reached KLS IV by 6-12 months after treatment.

    It is not true that they have "little to no muscle in their lower extremities". They have muscles and the muscles are moving their legs to take the steps. Many are walking 6 hours a day and many hundreds of meters. This is minimally assisted stepping. Nobody is pushing the legs to make them take steps.

    They are wearing no braces except for stretchy band placed in a figure 8 around the ankles and feet to reduce foot drag during walking. At the KLS IV level, the subjects are walking with the help of a rolling frame and somebody walking behind them with ropes to prevent their knees buckling. When walking long distances and times, the subject's quadriceps become weak and the legs may buckle. The ropes prevent that from happening.

    Two of the subjects are walking better than KLS IV, i.e. one is walking at KLS V (using the walking frame without somebody using ropes to stabilize the knees during stance phase), and one is walking at KLS VI level (using a four-point walker without anybody helping). We don't yet have one year followups on 5 of the subjects.

    Wise.

    Still great news.....Also for you Dr. Wise isnt it?? Did you expect those results when you started the trial??

    Does the follow up includes constant MRI´s?And are there patients in the trial who have instrumentation in the back? What do you do with those?

  8. #28
    Quote Originally Posted by Wise Young View Post
    It is not true that they have "little to no muscle in their lower extremities". They have muscles and the muscles are moving their legs to take the steps. Many are walking 6 hours a day and many hundreds of meters. This is minimally assisted stepping. Nobody is pushing the legs to make them take steps.
    Thanks for the additional information, that really sounds great. But I think you're a little quick to read into my statement that I was criticizing the results. What I meant by the statement was that the type of walking that you describe, even if not functional, could be therapeutic as it would strengthen muscles (I meant little to no muscle prior to the trial). Anyways, thanks again...

  9. #29
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    Quote Originally Posted by Wise Young View Post
    They range from 4-20 years after injury, mean 13 years. 15 of 20 subjects are taking steps and walking at the KLS IV level. Wise.
    This is the great news I've never heard in my last 16 years in a wheelchair! Why are people in this forum so quiet??

  10. #30
    Quote Originally Posted by KK11 View Post
    Still great news.....Also for you Dr. Wise isnt it?? Did you expect those results when you started the trial??

    Does the follow up includes constant MRI´s?And are there patients in the trial who have instrumentation in the back? What do you do with those?
    These results are better than we expected. These are randomized but not controlled or blinded studies. The subjects received escalating doses of umbilical cord blood mononuclear cells (UCBMC) starting at 4 µliters, then 8 µliters, and 16 µliters injected four times into the spinal cord. Each µliter has 100,000 cells. Therefore, these three doses represent respectively 1.6, 3.2, and 6.4 million cells. The trials indicate that all three doses are safe and provided the rationale for further phase III trials.

    In Hong Kong, we studied 8 subjects. The first four received 1.6 million cells and the second four received 3.2 million cells. None received walking training and none walked. The patients did not get "constant" MRI's. They had MR/DTI's before, 6 months, one year, and 1.5 years after treatment. Only 5 had MR/DTI that had reasonable quality, sufficient to see the white matter in the spinal cord. Two of the five showed fibers that crossed the injury site at 1.0-1.5 years after treatment. None had fibers that crossed the injury site before or at 6 months after spinal cord injury.

    In Kunming, we studied 20 subjects. Seventeen received 3-6 months of locomotor training; 3 did not complete their training due to complaint sof pain and possible fractures in their legs, although later review of the records suggest that the subjects did not have new bone fractures. In any case, 15 of the subjects achieved Kunming Locomotor Score IV by 6-12 months, i.e. walking with minimal assistance. They did not do MR/DTI tests of the subjects. The motor and sensory scores of the subjects did not correspond with the walking.

    I want to emphasize that these results are preliminary and the reasons why we need do phase III double-blind randomized controlled trials to confirm the results. We are planning phase III trials of 120 subjects in China and 120 subjects in the India (n=40), Norway (n=40), United States (n=40). We are currently discussing these phase III trials with investigators and trying to get a consensus on the clinical trial protocol.

    We must get these trials approved by regulatory authorities of all four countries. Getting approval will not be trivial tasks. We cannot apply for the phase III trials until we have investigator consensus and all available safety data. China is requiring that we set up cell processing facilities in China and getting all these facilities approved by regulatory authorities before we can start the trials. We need to do training of all the centers.

    The trials cannot be initiated if we don't have funding. On May 16, we are having a fund raiser for JustADollarPlease.Org at BBKing's on 42nd Street, to raise money for the U.S. trials (organized by Boyd Melson and Cristan Zacagnino). We are doing a fundraiser in Hong Kong (ATV) on June 27. We are planning a fundraiser in India. I was just in Norway to talk about the trials. Stemcyte is planning to do an IPO in Taiwan. If the IPO is successful, they will be able to help more with funding of the trials.

    Wise.
    Last edited by Wise Young; 04-29-2013 at 07:31 AM.

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