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Thread: Live from Working 2 Walk 2011!

  1. #21
    great work Kate
    good questions Paolo

    keep it up!

  2. #22
    Thank you so much Kate, for the great work that you are doing

    Paolo you Rock ! good questions straight to the point good work ! i hope someone do the same with Dr. Davies
    Last edited by Johnnie Walked; 10-16-2011 at 05:55 PM.
    keep (rolling) Walking

    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

  3. #23
    Senior Member kate's Avatar
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    Dr Fields breakout room

    17 people in a room that's like a little classroom, Dr. Fields generously hanging out in his formal business clothes, relaxed and just chatting.

    Talking about glia. Astrocytes operate in networks . . . how are they ordered, how do they get arranged, do they change?

    Sci is what's brought the whole field of glia to life -- we're really not talking about neurons today, right? The reason for that is that they're nothing wrong with them, in the sense that they're trying to repair, but they can't because the environment is so hostile.

    What do you think about chondroitinase . . .

    We're really excited about that opportunity -- the chance to do some re-engineering to take advantage of what's there. What stops the injury from spreading all through the cord is the scar, which then becomes a bad thing.

    What about scaffolding? It's going to be a big help in extending gaps . . .

    Why does myelin inhibit axon outgrowth? Myelin happens at the time that a circuit becomes functional. The first thing that gets myelinated in a fetal brain is the auditory system. Once a circuit becomes functional, those circuits become myelinated -- the thing becomes structured in such a way that you can't make new circuits. This is why a native Japanese speaker cannot ever hear the difference between r and l -- because in their natural environment they never hear those sounds and thus don't form the circuit that would allow them to hear them.

    Humans are special because they have brains that continue after they're born; we can adapt to whatever's in our environment. From the sci perspective, it's an unfortunate side effect that myelin is biologically destined to say: this thing is done. Don't mess with it anymore.

    So why is the CNS protected? Once it's damaged, there is no protection.

    Myelin was mistaken as insulation for a long time -- 26 years -- what's understood only recently is that myelin's real job is to fix brain circuits in place, to signal the moment when something has been learned.

    With brain imagining, you can watch physical changes happening in the brain when someone is learning something new. Current issue of National Geographic is about the teen brain; article mentions my work.

    The brain's plasticity is very strong in younger people and not so much in older people . . . how does this apply to physical activity as a way to rewire the brain?

    Saw a thing at a neuroscience program where blind people were learning text to speech programs . . . the blind people can understand speech 3 times as fast as sighted people. How? Under an mri, their visual cortex was responding to auditory information. This only worked for people who became blind at some point after birth, because the visual cortex wiring had become formed and was therefore available to be re-wired.

    So how does fes help form myelin? M work showed that these cells can sense electrical activity in axons . . . they know that the axon is firing, and that firing stimulates the glia and they form more myelin. In the opc studies, the idea is that the opc's should go in and myelinate the axons. Are they? Don't know. the cord has glia, so why aren't they mylenating the axons? Maybe through activity or fes or even a drug we can stimulate growth. We're trying in my lab to reproduce what happens in nature.

    Wow, this is over. Interesting guy.

  4. #24
    Senior Member kate's Avatar
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    Breakout Two Wise Young

    Bigger room, about twice as many people, talking about methods in China for walking training, which is done for all levels of injury and severities of injury.

    What they're currently doing in China would be considered a phase II trial; they have 16 people who've received the ucbmc and lithium.

    Everybody who can tolerate walking walks, every day, 150 patients every day walking with assistance. About half of them get to a sort of ability to move with a big, sturdy walker type device.

    There doing trials in the USA, India, and Norway to figure out how things change

    In January 2012, they're asking the fda for permission to run a trial in Austin at Breckenridge, hopefully to begin next April. 20 subjects with chronic sci will be treated with ucbmc plus lithium and then randomized to either rehab or standard rehab plus locomotor training.

    The inclusion criteria are: age 18 - 64, chronic for more than a year, and (i think) t12 - c5, all ASIA scores eligible.

    Two weeks from now Wise is bringing a whole team of Norwegians to China to get them up to speed on what will happen. The philosophy of the Chinese is to walk overground and to provide as little support as possible. They deal with foot drop using elastic bands. Has now been visiting Kunming for 7 years and they achieve a very, very good walking. ALL their incomplete patients walk. The one issue that we in the USA network have not been able to get our physiatrists to agree on is a rehab program. They think 3 hrs a day, 3 days a week, for 3 months is very intensive. In China it's 6, 6, 6 . . .

    Our Austin patients will be in an army-style hospital, which we think might be the ideal sort of place to have them try for a 6, 6, 6.

    How about the lumbar injuries? We think they'll need neural stem cells, which is why we're watching neuralstem with great interest.

    We have so many patients in China, and now that we've trained the doctors and got the centers going, we're going to have a lot of data to show the fda.

    In Hong Kong and China we're not doing a formally randomized trial, but we will in Austin -- no, not randomized because you can't hide the fact of walking 6 hours a day from the patient. He's going to know! It's exciting that so many people in the community are showing interest in helping out with this, because it will require a lot of volunteers. Football teams, cheerleaders . . they want to help.

    Many doctors have gone to China, but they don't believe that 6,6,6 can be implemented in the usa. Patients won't stand for it. PTs would hurt their backs. It's not economically feasible, because hospitals in China are so much cheaper than they are in the US.

    One big thing we're worried about with chronic patients in the US is that so many chronics have weight issues and of course are not standing at all. They may have femur fractures. If you get a pathological fracture, you can't walk.

    Why would you take lithium orally instead of by injection? Because 35 million people take it orally, and it works.


    Will update this with comments from Wise later . . .

  5. #25
    Quote Originally Posted by kate View Post
    Bigger room, about twice as many people, talking about methods in China for walking training, which is done for all levels of injury and severities of injury.

    What they're currently doing in China would be considered a phase II trial; they have 16 people who've received the ucbmc and lithium.

    Everybody who can tolerate walking walks, every day, 150 patients every day walking with assistance. About half of them get to a sort of ability to move with a big, sturdy walker type device.

    There doing trials in the USA, India, and Norway to figure out how things change

    In January 2012, they're asking the fda for permission to run a trial in Austin at Breckenridge, hopefully to begin next April. 20 subjects with chronic sci will be treated with ucbmc plus lithium and then randomized to either rehab or standard rehab plus locomotor training.

    The inclusion criteria are: age 18 - 64, chronic for more than a year, and (i think) t12 - c5, all ASIA scores eligible.

    Two weeks from now Wise is bringing a whole team of Norwegians to China to get them up to speed on what will happen. The philosophy of the Chinese is to walk overground and to provide as little support as possible. They deal with foot drop using elastic bands. Has now been visiting Kunming for 7 years and they achieve a very, very good walking. ALL their incomplete patients walk. The one issue that we in the USA network have not been able to get our physiatrists to agree on is a rehab program. They think 3 hrs a day, 3 days a week, for 3 months is very intensive. In China it's 6, 6, 6 . . .

    Our Austin patients will be in an army-style hospital, which we think might be the ideal sort of place to have them try for a 6, 6, 6.

    How about the lumbar injuries? We think they'll need neural stem cells, which is why we're watching neuralstem with great interest.

    We have so many patients in China, and now that we've trained the doctors and got the centers going, we're going to have a lot of data to show the fda.

    In Hong Kong and China we're not doing a formally randomized trial, but we will in Austin -- no, not randomized because you can't hide the fact of walking 6 hours a day from the patient. He's going to know! It's exciting that so many people in the community are showing interest in helping out with this, because it will require a lot of volunteers. Football teams, cheerleaders . . they want to help.

    Many doctors have gone to China, but they don't believe that 6,6,6 can be implemented in the usa. Patients won't stand for it. PTs would hurt their backs. It's not economically feasible, because hospitals in China are so much cheaper than they are in the US.

    One big thing we're worried about with chronic patients in the US is that so many chronics have weight issues and of course are not standing at all. They may have femur fractures. If you get a pathological fracture, you can't walk.

    Why would you take lithium orally instead of by injection? Because 35 million people take it orally, and it works.


    Will update this with comments from Wise later . . .
    i am ok with cheerleaders helping.
    im glad i made my most recent purchase of an easystand.
    and im ready for the 6 6 6.

    thanks very much kate. im really interested to hear more of wise youngs comments!

  6. #26
    Senior Member kate's Avatar
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    Jonathon Slotkin Breakout

    Hmmm. another big room, this one kinda cold, lots of people. He was going to just keep going with this conversation and not let everybody go and start over.

    Then some people left . . . so, now to questions.

    Geoff Kent wants to know how it makes business sense to work with acutes. It doesn't. We can't talk the fda into letting us jump into chronics; they have a knee jerk response. Some regulators and a lot of investors do not believe that chronics are not interested in losing what they have.

    Well, there are a lot of people in chairs -- in major organizations at senior levels -- say that same thing.

    The administration needs to know that this community wants to be involved in good research here in the usa . . . not just members of congress, but the administration. There are a lot of people travelling in droves as medical refugees. Some of the coverage of the overseas studies glorifies the news.

    The questions that we got back from the fda were great, medium, and rudimentary, displaying a pretty shocking lack of knowledge about the physiology of sci. You can see that there's a low level of understanding, even there. But our applications go through the center for devices and not the center for drugs, which is faster. When we go to add the drug to our device we'll see what happens, but there is precedent.

    The fda is forbidden by law to dictate the practice of medicine -- which means that if i get the device approved and want to use it in an off label fashion, it's my discretion.

    So you're saying that the only reason to focus on acute research is to get fda approval so that you can create the possibility of getting to chronics faster.

    Can you make money with acutes? Maybe; the one variable you don't know is what's the product cost per patient. A two-level spinal fusion would cost how much? The hospital would collect $75,000 or so . . . the company called Stryker Inc that makes the rods and screws and interbodies and machined bone, etc. -- that's worth $21,000. Let's assume a treatment for acutes worked perfectly, and could be delivered to about 7,000 new injuries every year and you could get 60,000 per patient . . . that would be $420 million per year.

    Someone speaks up to say that it's not just money that makes it a good idea to fix acutes. It's that if you can do such a thing, you must.

    Once a lot of the acute legwork is done, we'll have an easier path. The case can be made that for scaffolding, the chronic cord is MORE hospitable than the acute cord. The idea is going to be

    I'm back to your point about advocacy for chronic injuries; I'm a PT and I know a lot of chronics who desperately want this. How do we do this? If you could write the script, how would you do it? I know a lot of people who take ridiculous risks to get better . . . how do we make this case, who do we make it to? Well, the fda is part of the executive branch, so . . . ?

    If I was chronically injured, I would focus on the fda. The research dollars is a whole separate animal, that's the NIH.

    What happens after you submit your application? We get a list of questions within 30 days. We must answer them all. About 5% of them are real, difficult questions. One of our attorneys said that she can tell that the language they used meant they were putting us into their "special" category, meaning that they were impressed that we're genuinely trying a novel approach to a very difficult problem.

    We've requested a live meeting with the fda to talk about their questions to talk about our device; there will be a chemist, a neurosurgeon, a pharmacologist -- they get bios of all these people in advance. They will prepare for this meeting by making sure they'll have someone who can respond to what we say.

    Their purpose for this meeting is for us to bring them questions, so we prepare our answers as if they were questions.

    How do we reach out to investors? That's his job, he says.

    Have any of us every reached out to the commissioner of the fda? Not that we know of. Our message to them should be that we want to be sure they understand that

    a. lots of companies are going to be submitting applications
    b. we want to be sure they have the knowledge base to work with them
    c. we're very, very interested in seeing that those applications get serious consideration

    What if somebody offered you $50 million to try the device on them? I'd take the money and use it to blast out a primate study to prove that it was safe, and then I'd give it away to the donor.

    What if you put neural stem cells into your scaffold? We've done that with primates and it works quite well . . . we've also been in touch recently with Stem Cells Inc., who realize that there's going to need to be a scaffold.

    What's my dream product? The scaffold plus cells and drugs together. We've done it in primates with each one individually, and we'll get to that.

    How do you individualize your scaffold? It's going to come in a number of sizes and then be customized by the surgeon. For the injectible one, different issues.

    How long does it last? 8 - 12 weeks.
    Is it brittle (glasslike in the fda's language)? No. it's density when wet is a lot like the human spinal cord.

    What kind of material are you planning to put into the clinical trial? What formulations are being tested?

    The application in the fda is a solid state, surgically implanted scaffold. We anticipate within the next several months submitting an injectible drug-releasing version of this scaffold. The scaffold alone has been shown to reduce the cavity all by itself. And the surrounding tissue gets subjected to lots of stresses, so it's possible that there's just a

    The job of the injectible is to manage the slow release of drugs . . . maybe chondroitinase, maybe some stuff with Stephen Davies. The chronic folks are heavy on our minds, and we know that whatever kind of drugs they end up needing, they're going to need a vehicle for delivering those drugs safely.

    We asked our fda experts, Janice Hogan, what's the right strategy with them. She said to start with nibbles and open a conversation. The scaffold ind is built around a set of well-known surgical procedures.

    How does your scaffold compare to the hydrogels currently on the market?
    Every hydrogel before ours was limited by a simple chemical property that it expands in vivo . . . if you place it in a confined space, you're going to get trouble. There have been case reports in the literature of duragel causing death. Our scaffold doesn't expand . . . in addition, we have 14 domestic patents, meaning any work being done on any of those hydrogels won't get to market without us.

    What about nanotech? It's a different story . . it's sort of the dream of the next couple of decades. It's where scaffolding was 10 or 15 years ago. I could get excited about this at some point . . . although the only thing that scares me more than an fda panel for our device is facing one for nanotech.

    I think that the last 10 years has been the cell story, and the next ten is going to be the biomaterials, and then it will be nanotech.

    The fda needs to optimized to deal with two drugs in one scaffold; they can't ask for another combination 7-year trial in addition to 3 separate 7-year trials (one for each drug and one for the scaffold). That's not the way they're set up, and they need to figure out how to manage those sorts of things.

    One thing you never do is let anybody put a bolus of cells into you; they'll end up everywhere in your body and not just in your cell.

    Last question: chondroitinase and heat sensitivity? Don't know, good question for my engineers.

    Doesn't your scaffold, when put into the cord of a chronic, cause damage? I don't have any reason to think that. This isn't a re-injure the cord idea.

    Okay, we're done. Reception time.

  7. #27
    Senior Member tarheelandy's Avatar
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    Thanks so much Kate!
    Wow, very interesting about Ed Wirth leaving Geron. I think I had heard him say when he left that he doesn't agree with them accepting big pharma money, like they did with Geron. Well we know that he is legit so this help Invivo look more reputable to me (even with Frank Reynolds!).
    Last edited by tarheelandy; 10-16-2011 at 06:08 PM.

  8. #28
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    Many doctors have gone to China, but they don't believe that 6,6,6 can be implemented in the usa. Patients won't stand for it. PTs would hurt their backs. It's not economically feasible, because hospitals in China are so much cheaper than they are in the US.Many doctors have gone to China, but they don't believe that 6,6,6 can be implemented in the usa. Patients won't stand for it. PTs would hurt their backs. It's not economically feasible, because hospitals in China are so much cheaper than they are in the US.


    Kate,
    An easy way around this issue is the use of exercise physiologists under the supervision of PT's. We've been doing 4 4 4 in our gym for 3 years with no trainer injuries. In fact the physiologists love the whole body workout.

  9. #29
    Who wouldn't do 4,4,4 if it was with the goal of walking again - 6 days a week seems a little extreme, how would you get staff to come in in the weekend?

  10. #30
    Quote Originally Posted by Christopher Paddon View Post
    Who wouldn't do 4,4,4 if it was with the goal of walking again - 6 days a week seems a little extreme, how would you get staff to come in in the weekend?
    seems extreme, but id do it. its only for 6 months.

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