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Thread: What about chronic incomplete spinal cord injuries?

  1. #1

    What about chronic incomplete spinal cord injuries?

    Quote Originally Posted by KyleP2112 View Post
    Wise,

    I have a question for you about chronic incomplete injuries like mine, which was at c4/5 in 1995 when I was 17. How much longer before chronic injuries have a therapy or "cure"? Where does research on chronic incomplete injuries stand?

    I sometimes wonder if we're running out of time as those of us with sci get older and the health issues mount. This issue was magnified after seeing my friend Christopher Reeve die of complications. By chance Chris and I were in rehab together at Kessler in northern NJ as he was injured 2 weeks before I was. His death really was a tragedy...

    Thanks for your time Wise...Kyle
    Kyle,

    I moved your question to a new thread. Let me try give you my best guess instead of spouting the usual "I don't have a crystal ball" answer. But before I talk about the timing, let me address the question of complete and incomplete.

    Most trials today focus on "complete" spinal cord injury because doctors think that it is safer and more likely to show beneficial effects in complete spinal cord injuries because such people have less to lose and are less likely to show spontaneous recovery.

    In my opinion, there is a big difference between somebody who was a "motor incomplete" (ASIA C) shortly after injury and somebody who was an ASIA A and then recovered anal sensation and some function to become a chronic ASIA C. Being a chronic incomplete does not have the same prognostic implications as an acute incomplete.

    Christopher Reeve and most people with chronic spinal cord injury are chronic incompletes. We should coin a new name for this condition, i.e. a person who was originally ASIA A and recovered some function and is now ASIA B or C. Let us for the sake of discussion name that condition ASIA A+. I am hoping to convince my colleagues to include ASIA A+ cases in our trials.

    Suppose that we include ASIA A+ subjects in our upcoming trial, this would mean that people with incomplete chronic spinal cord injury would be getting therapies with about the same time frame as those with "complete" spinal cord injuries. So, assuming that we do so, what is the time frame for therapies to treat incomplete chronic spinal cord injury?

    I am optimistic that we will see some positive results in our current trial assessing umbilical cord blood mononuclear cells (UCBMC) and lithium. Of course, I can't guarantee it but, if so, we are talking about having a therapy that restores some function in some people with chronic spinal cord injury by 2014.

    Whether UCBMC+lithium therapies are effective (or not), we will go on to the next set of therapies, which we are currently thinking should be Muse cells and Cethrin (combined with UCBMC and lithium, if our current trials are successful). It should take another 3-4 years to move these therapies from phase I/II to phase III and regulatory approval.

    On average, it takes the pharmaceutical industry 10-12 years to move one therapy from the laboratory through regulatory approval. This would be with full funding (i.e. hundreds of millions of dollars). We have brought UCBMC±lithium through Phase I, II, in 5 years and for less than $3 million and I hope less than $12 million for phase 3.

    This is beginning to turn heads in the industry and to convince them to invest in clinical trials of the chronic spinal cord injury therapies. So what will happen when many companies start to invest in chronic spinal cord injury trials? If the companies started from scratch, it will take them 10-12 years. However, if they use our networks, they should be able to move much faster.

    It is unfortunate that it has taken so long to set up the networks for clinical trials around the world. The lack of funding and the pessimism of the field have not helped. We have done it despite both of these obstacles.

    Wise.
    Last edited by Wise Young; 06-13-2012 at 02:30 PM.

  2. #2
    Dr. Young,

    Is the phase 3 trial in China still going to include ASIA A, B and C? How can you be sure that any improvements shown in complete injuries will be similarly manifested in incomplete injuries?

    If the UCB+lithium treatment shows some benefit in complete injuries and gets FDA approval, I am concerned that doctors will be reluctant to perform this procedure on less severe injuries.

    Thank you very much.

  3. #3
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    Dr. Young,

    Thank you so much for everything you do and also for the time you take to answer all our questions.

    Let's say your trial will show good results and by the end of 2014 you will finish the phase III.
    How soon after the phase III ends do you think that people with chronic SCI can benefit from this therapy? How soon it will be available in hospitals?


    I'm from Romania and I am willing to undertake the therapy wherever is available: China, USA, ...
    Do you think I can enroll in ChinaSCINet phase III trial, if I met all the conditions?

  4. #4
    Moderator jody's Avatar
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    less than two years? wow.

  5. #5
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    Thank you for your very interesting response Dr. Young.

    Your detailed response really helped me get a better grasp on the details and current status of my injury. Now I can see why researchers need to tread carefully depending on a person's injury...it would be terrible to lose what function and sensation I have below my level of injury.
    From what you posted I believe my injury is a chronic ASIA C or ASIA A+...I say that because w/ my injury level at C4/5 I can move my wrists, have some muscle movement in my torso & about a year ago notice I could move the thumb on my right hand some. For sensation, I do have sensation in the anal area (which I know from doing the bowel program), in my feet & some parts of my legs & hips...the sensation is not so good in my hands, stomach area or back.

    What do you think? Thanks for your time....Kyle

  6. #6
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    I believe that ASIA (AIS) is a standard - good or bad - without trying to create sub categories, for whatever reasons. And if so, it has to be done by a wider consensus, and not for specific projects. Cause then all might be diluted and even more vague. Methinks.

  7. #7

    Dr Wise

    I gotta question can these muse cells grown into large populations? Say if we needed 10 million cells for a transplant?

  8. #8
    Quote Originally Posted by KofQ View Post
    Dr. Young,

    Is the phase 3 trial in China still going to include ASIA A, B and C? How can you be sure that any improvements shown in complete injuries will be similarly manifested in incomplete injuries?

    If the UCB+lithium treatment shows some benefit in complete injuries and gets FDA approval, I am concerned that doctors will be reluctant to perform this procedure on less severe injuries.

    Thank you very much.
    KofQ,

    We will be having that discussion soon. I have the same concern as you expressed and it is the main reason why I proposed to include ASIA A, B, and C in the phase 3 in China.

    There will be several arguments against that proposal. First, including subjects with A, B, and C will increase (perhaps double) the number of subjects required to show statistically significant effects. Subjects that have "incomplete" injuries may be more variable that those with "complete" injuries. Second, we did not include incomplete subjects in the phase 2 trials. Third, we have not yet proven the safety of injecting cells into spinal cords of subjects with ASIA B and C.

    I believe and hope that my colleagues in China understand and have the same appreciation that I do, that there is not much difference between subjects who are chronic completes versus chronic incompletes, that it is important to test such subjects with chronic incompletes, and that the risk of losing function is low with our method of injecting cells at a 45 degree angle into the dorsal root entry zone. The main argument may be the extra number of subjects and therefore the increased cost of such a trial. We shall see.

    Wise.

  9. #9
    Quote Originally Posted by robyc View Post
    Dr. Young,

    Thank you so much for everything you do and also for the time you take to answer all our questions.

    Let's say your trial will show good results and by the end of 2014 you will finish the phase III.
    How soon after the phase III ends do you think that people with chronic SCI can benefit from this therapy? How soon it will be available in hospitals?


    I'm from Romania and I am willing to undertake the therapy wherever is available: China, USA, ...
    Do you think I can enroll in ChinaSCINet phase III trial, if I met all the conditions?
    The investigators decide who meets the criteria. One of the most important criteria is the judgment of the investigators that the subject will come back for the followup examinations. If they have doubts that the subject may not come back for followup examinations, investigators have the freedom to turn down the subject. One of the reasons why we decided to push for trials around China, India, Europe, and the U.S. is to accelerate approval of the treatment around the world.

    By the way, the IANR (International Association of Neurorestorology) symposium will be held in Bucharest next May. Perhaps we can do part of the trial in Romania. A lot depends on how successful we are in fundraising for the trials. We have not yet raised all the funds necessary to do the trials in all these places and I am flying around trying to get sufficient support for the places that we are planning the trials. I am reluctant to expand the trial until we have the resources to do so.

    If the phase 3 trial confirms that the treatment is effective, I think that the treatment will be rapidly adopted around the world. If the trials show that intensive locomotor training is necessary for the recovery, the training program will be more expensive and may encounter greater difficult to disseminate than the surgery. In other words, we have two populations of doctors to convince... spinal surgeons (neurosurgeons and orthopedic surgeon) and rehabilitation doctors. Much depends on the results.

    Wise.

  10. #10
    Quote Originally Posted by Leif View Post
    I believe that ASIA (AIS) is a standard - good or bad - without trying to create sub categories, for whatever reasons. And if so, it has to be done by a wider consensus, and not for specific projects. Cause then all might be diluted and even more vague. Methinks.
    Leif,

    Thanks. We should be saying AIS or ISCOS when we refer to A, B, and C. However, many people may not recognize AIS or ISCOS A, B, and C and so I have been using ASIA A, B, and C. At some point, I should shift the terminology to ISCOS A, B, and C.

    I suspect that what you express will be the thinking in Norway. If we include ASIA A, B, and C, we will have to increase the number of and stratify the subjects during randomization so that ASIA A's will be analyzed separately from ASIA B's and C's. If so, there should be no impact on the rigor of the trial and the trial should still be convincing.

    We would have to convince the investigators and the Institutional Review Boards (IRB) in Norway may require a phase 2 trial on ASIA C's before including them in the phase 3 trial. That would delay the phase 3 trial. That is why I had proposed to do only ASIA A's in Norway. We shall see. If the investigators think that we should do ASIA B's and C's, we can try.

    By the way, I have to come to Norway soon to discuss these issues with the investigators in Norway. I just got back from China last week and will be heading back this coming week. It will be my third trip in six weeks. Sigh.

    Wise.
    Last edited by Wise Young; 06-14-2012 at 07:51 AM.

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