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    #16
    Dalton Deitrich, the Miami Project

    Whoops, missed the intro

    Here's what Dr. Dalton is talking about:
    Areas of research?
    Neuroprotection
    Transplantation and regeneration
    Rehabilitation
    Quality of Life
    Clinical trials
    Next Generation training

    We've been at this for 26 years . . . our model is bench to bedside, bedside to bench.

    based on needs, we do basic science research, which leads to preclinical translational studies, which leads to clinical investigations, which leads to clinical trials . . . the holy grail.

    It's a big puzzle. We've been all over the world, recently returned from places like India and China . . . there are 5.3 million people living with paralysis due to some kind of central nervous system injury.

    Promising treatment list up for about 4 seconds, and it vanishes before I can type it.

    What are some of the mechanisms of cell death? depolarization excitoxicity, ischemia, inflammation and edema . . . what do you do with that? In 1986 I wrote a paper showing that if you reduce the temperature of the brain 2 degrees in a rat experiencing cardiac arrest, you get a better outcome.

    In 2000 they published a paper showing that if you cool rats after thoracic sci, they get 32% more recovery. In 2009 they published another one showing that it works after cervical sci, too . . . this work has been replicated all over the place, which means it's reliable.

    A problem is that there are no clinical guidelines or protocols establishing efficacy . . . but because of media attention people started using it. Showing pictures of Kevin Everett, who was injured in September 2007. He got an iv infusion of cold saline about 15 minutes post injury. Next thing I knew I was getting a call from Sports Illustrated. It's great, but it's just one guy and doesn't mean anything.

    What you need is a controlled clinical trial, where some patients get the therapy and some don't. We've been doing this at Miami for patients who can get to us within 6 hours post injury. We did 14 patients in a safety trial -- saw no evidence of risk factors. (Clinical Application of Modest Hypothermia after SCI)
    You use a vascular catheter that cools the blood to any temperature you choose, and when it's time to re-warm the patient, that's easily done.

    The Asia A conversion rate is 43% to Bs and Cs. They're very optimistic and now planning a bigger trial called ARCTIC . . . it will cost 10 to 12 million dollars. NIH liked it but didn't fund it. It's a five-year project. They're going to re-write the grant and re-submit it.

    Okay then.

    What about repair studies? What about replacing lost neurons? They're focused on "helper cells" -- made to change the environment to make it more permissive to regeneration. Schwann cells are myelinating cells taken from the peripheral nervous system, which come with a lot of solid preclinical data indicating that they'll be effective.

    Why that one?

    It releases growth factors, it can re-myelinate axons that have lost their myelination. So, its task is to do the same things that Geron's OPC's are doing, except it's your own cell. We can take one of these from you, culture it for 3 weeks, and put it back into your body without worrying about your immune system rejecting it.

    But they had the rats walking "beautifully" in 2004. What has happened since then?

    You can now use viral vectors to turn these cells into "super cells" -- which means you can get the Schwann cell to carry the 3 kinds of growth factors that have been shown to work.

    So, how do we get to the bedside? We felt the need to do some careful studies with pigs. We've been using the Geron injector . . paper published this year by Guest et al on how this worked. They also did some primate studies with extremely positive results. They submitted their IND to the fda last month. Picture of 4 scientists with a stack of paper about 2 feet high.

    They also have plans for 3 kinds of future IND submissions: two of which are for chronic. We're really proud of this.

    NIH News blueprint neurotherapeutic network

    And at their website now you can read about other projects underway.

    Comment


      #17
      John Slotkin and Frank Reynolds, INVIVO

      Jonathon Slotkin is the medical director at InVivo; he's on the television a lot talking about sci

      Yay, gives a plug for the live blog! Thanks.

      You're going to get the first public announcement of an excellent piece of news.

      We've just appointed Ed Wirth as our chief science officer. He's coming to us from Geron, where he'll be leading us into human clinical trials. We also have Reggie Edgerton from UC Irvine.

      We've submitted an IND to the fda 2 months ago.

      There are 2 parts to an sci -- the primary and the secondary injuries.

      Hall E springer J neuroprotection and acute spinal cord injury 2004

      There's a well known cellular inflammatory response in the days and weeks following injury. Lots of the people in this room have been working on a long list of potential treatments . . . here's the list

      OEG, stem and progenitor cells, inhibition of NOGO, growth factors, pharmacologic strategies, activity based strategies, macrophages, schwann cells, etc.

      This is an engineering problem, though. It's an engineering problem because there's a physical hole. It's a big leap to ask cells to do magic, to do a leap over a hole . . . we have an inhospitable biological environment. It's our belief that engineered biodegradable scaffolds might be able to do the job. Paper on this is published and free (Teng et al 2002)

      The scaffold had components made for both gray and white matter to attach to. That first formulation didn't work, but it led to some fantastic results.

      Showing a slide about GAP 43 immunocytochemistry, where they used the scaffold along with neural stem cells. That worked. Ah, showing a video of a poor brown sequard-lesioned rat trying to walk. Then another one doing much better, after treatment with scaffold + neural stem cells.

      Good slide showing paper after paper about polymer scaffolds, rising into a pile on the screen. I'll get the list from him later.

      Saying that primate studies must be reserved for only the very most promising of therapies and limited to thoracic hemi injuries. Courtine, edgerton in 207 published a paper about how experimentation in primates can expedite translation into humans.

      Lots of you know that everything seems to work in rats . . . but what will work in primates will be much more likely to work in humans. When I'm in the clinic, I always bring it down to one question. What would I want if it was my back?

      So.

      They did a study with biodegradable polymer scaffold at St. Kitt's biomedical research center involving African green monkeys. They publisshed the preliminary model pritchard slotkin langer 2010. They've done about 40 animals.

      Some controls, some scaffold alone, some scaffold plus growth factors, some injectable, drug-releasing scaffold. They did a wireless EMG application 4 weeks prior

      Okay . . .

      He's building up to something here.

      He's saying that treatment with methylprednisolone has been identified as involved in serious side effects, but we wanted to use it anyway because it does have good outcomes too.

      Reggie Edgerton's wireless EMG application allowed them to capture kinematic data about swing and stance pattern of animals before and after treatment and injury. The data you can capture is astonishing. The animals that got the injectible scaffolding are looking good. This is going to turn into something.

      okay, I have to clean this up a lot, but need to post it so I can get the panel discussion . .
      Last edited by kate; 16 Oct 2011, 3:04 PM.

      Comment


        #18
        Panel with Paolo Cipallo plus Dietrich, Slotkin, Reynolds

        Paolo wants to know if they think we're supposed to get excited by hearing about hypothermia? W here is the chronic work? There aren't any acutes in the room. I don't get it.

        Slotkin: Well, it's constantly on our minds -- for one thing because investors know that there are a lot more chronics than acutes. We do acutes first because those models are more well-established and easier to fund. Right now we're raising a colony of chronically injured animals.

        How many?

        Right now just in the pilot stage with a couple of hemisection (not contusion) thoracic. Also what about hypothermia, since that was brought up? That football player didn't just get hypothermia, he got rapid decompression, because he was lucky enough to have a spinal surgeon standing next to him when he got hurt. So we don't really know what it was that helped him.

        Dietrich: We did show that Schwann cells can be transplanted 6 months post, and have published rat studies where the treatments were delayed. If you come to the Miami project, you'll find the whole first floor full of people in chairs -- we have targeted chronics, we will target them. I hope you get it.

        Sorry, I don't. Why is there not 50% of the work being done on chronics? I would say it's like 95% of the work is being done on acutes. I have given you money before, but I'm not doing that anymore. It doesn't make sense. I don't get it.

        Dietrich: Our strategy is to go to the fda and get the easiest thing done first, according to them, and move forward into chronics as quickly as we possibly can.

        Seems like hypothermia is a no-brainer . . . didn't we know about that since 1976? I was injured 3 years ago and nobody offered it to me. Congratulations to you, Dr. Dietrich, for making that sports doctor aware that it was even possible. I just want to underline the fact that we need to move this field forward a lot FASTER. If there's anyone from the fda in the room, I hope they're listening.

        Dietrich: Well, hypothermia has a lot of risk factors, and we've tried to refine the treatment . . . what kind of technology do you need to make it safe? It takes a long time . . .

        But cardiac patients already get hypothermia. It really feels like there's not enough aggression.

        Slotkin: Well, there's a paper in the NE Journal of Medicine about cardiac patients being taken off that protocol due to safety issues . . .

        Gah, need to stop. I want to keep doing this. Next is smaller workshop rooms, where I could ask questions if anybody has one.

        Comment


          #19
          if i were there, id want to ask wise young to tell me anything he could about the hong kong patients. specifically the one that is coming up on a year out.

          Comment


            #20
            Originally posted by kate View Post
            Jonathon Slotkin is the medical director at InVivo; he's on the television a lot talking about sci

            Yay, gives a plug for the live blog! Thanks.

            You're going to get the first public announcement of an excellent piece of news.

            We've just appointed Ed Wirth as our chief science officer. He's coming to us from Geron, where he'll be leading us into human clinical trials. We also have Reggie Edgerton from UC Irvine.

            We've submitted an IND to the fda 2 months ago.

            There are 2 parts to an sci -- the primary and the secondary injuries.

            Hall E springer J neuroprotection and acute spinal cord injury 2004

            There's a well known cellular inflammatory response in the days and weeks following injury. Lots of the people in this room have been working on a long list of potential treatments . . . here's the list

            OEG, stem and progenitor cells, inhibition of NOGO, growth factors, pharmacologic strategies, activity based strategies, macrophages, schwann cells, etc.

            This is an engineering problem, though. It's an engineering problem because there's a physical hole. It's a big leap to ask cells to do magic, to do a leap over a hole . . . we have an inhospitable biological environment. It's our belief that engineered biodegradable scaffolds might be able to do the job. Paper on this is published and free (Teng et al 2002)

            The scaffold had components made for both gray and white matter to attach to. That first formulation didn't work, but it led to some fantastic results.

            Showing a slide about GAP 43 immunocytochemistry, where they used the scaffold along with neural stem cells. That worked. Ah, showing a video of a poor brown sequard-lesioned rat trying to walk. Then another one doing much better, after treatment with scaffold + neural stem cells.

            Good slide showing paper after paper about polymer scaffolds, rising into a pile on the screen. I'll get the list from him later.

            Saying that primate studies must be reserved for only the very most promising of therapies and limited to thoracic hemi injuries. Courtine, edgerton in 207 published a paper about how experimentation in primates can expedite translation into humans.

            Lots of you know that everything seems to work in rats . . . but what will work in primates will be much more likely to work in humans. When I'm in the clinic, I always bring it down to one question. What would I want if it was my back?

            So.

            They did a study with biodegradable polymer scaffold at St. Kitt's biomedical research center involving African green monkeys. They publisshed the preliminary model pritchard slotkin langer 2010. They've done about 40 animals.

            Some controls, some scaffold alone, some scaffold plus growth factors, some injectable, drug-releasing scaffold. They did a wireless EMG application 4 weeks prior

            Okay . . .

            He's building up to something here.

            He's saying that treatment with methylprednisolone has been identified as involved in serious side effects, but we wanted to use it anyway because it does have good outcomes too.

            Reggie Edgerton's wireless EMG application allowed them to capture kinematic data about swing and stance pattern of animals before and after treatment and injury. The data you can capture is astonishing. The animals that got the injectible scaffolding are looking good. This is going to turn into something.

            okay, I have to clean this up a lot, but need to post it so I can get the panel discussion . .
            Thank you Kate. These guys will get it done before anyone else..
            Donnie: Dr. Xiao, What are your thoughts on a cure/combination therapy for SCI's??
            CG Xiao: Donnie, I don't want to disappoint you, but I think it is impossible to restore the continuity of the cord or "bridge the gap" in the near future, let's say: 50 years. Dr Wise Young has been my most respected scientist in SCI. He has dedicated and contributed to SCI no other can match.

            Comment


              #21
              great work Kate
              good questions Paolo

              keep it up!

              Comment


                #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; 16 Oct 2011, 5:55 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

                Comment


                  #23
                  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.

                  Comment


                    #24
                    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 . . .

                    Comment


                      #25
                      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!

                      Comment


                        #26
                        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.

                        Comment


                          #27
                          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; 16 Oct 2011, 6:08 PM.

                          Comment


                            #28
                            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.

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                              #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?

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                                #30
                                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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