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    #16
    sci 101

    Wise:

    I feel like i'm bringing coals to newcastle, but sometimes people hear litle nuggets that they didn't know before -- so we start at the very beginning.

    The brain connects to the body through the spinal cord
    Nerve cells (neurons) send nerve fibers (axons) down (motor) or up (sensory) the spinal cord.
    Sensory neurons are outside the cord, sending axons into the spinal cord while motoneurons in cord send axons to muscle. Important to realize that axons are NOT wires, they're living things. You need to grow new ones if they're damaged.

    What's the biggest cell in the body? An axon, which goes all the way from the brain to the furthest tip of the body. Repairing it is a tall ask . . .

    Revlexes . . there's a monosymaptic reflex, which is what causes your knee to jump when the doctor whacks it, and what causes spacticity in sci patients

    There's also multi-synaptic reflexes, which are what make babies' feet react.

    Wise is demonstrating what happens when you turn a baby's head, one arm goes out, one arm goes up, like a fencing move called musketeer.

    you need less than 10% of your axons in order to walk . . . that's why walking is one of the low-hanging fruit of research.

    so what happens during injury?
    the part of the axons that are isolated from the neuronal cell bodies dies.

    the neurons above and below the injury survive.

    showing a drawing of axonal injury . . . kinda weird that this extremely teensy little bit of the body has so many parts -- 10 of them are labelled in this drawing.

    what are the consequences of sci? oh, the dreadful list:
    paralysis
    sensory loss
    spasticity
    spasms
    allodynia
    neuropathic pain
    incontinence

    spasms are different from spasticity -- c. reeve used to suffer from spasms so bad they would throw him out of his chair, and the reason he used to go around with guards was so that no one touch him and trigger a spasm.

    allodynia -- hyperexcitable cord above the injury
    noxious -- (that sound horrible) real pain that may come back if there's a cure
    neurogenic -- like from phantom limbs

    so what's regeneration? how can axons be regenerated in such a way that they make the trip from the injury to the original connecting point. axons grow at the same rate as hair . .

    why don't our axons regenerate? it didn't evolve as a recovery mechanism because it took too long.

    instead, organisms evolved some other strategies: a bony armor called the vertebrae, redundant pathways . . .

    Comment


      #17
      Wise: Clinical Trials

      When I met Suzanne Poon (first I couldn't believe she had an 18 year old son), she asked me if we could do something in China.

      We formed a partnership in 2004 and set up the network in 2006.

      We had to choose a therapy to test . . . we picked umbilical cord blood + lithium. It was the most promising and the safest to do a clinical trial with. I didn't invent it.

      Showing a picture of a rat cord that has had a 10 gm weight dropped onto it from different heights. If the weight is dropped from 12.5 mm, the rats are injured but recover. Twice that height, they don't recover.

      Slide showing a cross section of an injured cord . . . there's a black hole surrounded by axons trying to get in but not growing out.

      So, how would you bridge the injury site? The site is filled with macrophages and astrocytes. If you put cells right into the middle of the injury, they're stuck there. So you put cells on the edges of the site (at 45 degrees) and they migrate in and form a bridge.

      What kind of cells should we use? In 2006, there were only two approved sources (GMP, he means, because it means the cells were sourced using Good Manufacturing Practices). Adult or neonatal GMP cells were either bone marrow or umbilical cord blood. The other options were fetal (from abortions) or ESC, which were not readily available in 2006.

      He likes cord blood cells because they stay where you put them. They also are recognized by the glial cells as part of the central nervous system and that means the glial cells don't attack them.

      What about lithium?

      it's a drug used for manic depression . . . we all have it in our bodies . . . it's very, very cheap. And it inhibits an enzyme AND increases cell growth. Wise had heard that it seemed to repair sci, so he put his cord blood cells into his injured rats, then treated them with injections of lithium . . .

      Showing a list of about a dozen papers published about how umbilical cord blood works in sci.

      Dasari published a paper (which I'll hook you to when I get a minute) that Wise is describing now. Rats were made to not just walk, but to walk on a beam, which is a lot harder. Also -- Wise is so funny -- demonstrates what it looks like to hold a dangling rat treated with lithium & cord blood and stroke its limbs.

      Yick 2004 (another paper I'll find and link to . . )

      Now doing CN 102b in china
      have a usa network, which will test the phase 3 study
      they will also be doing it in india
      showing a picture of a young chinese woman who was the reason for starting clinical trials
      suzanne poon shown surrounded by the rest of the china board

      Time for Ed Wirth, from Geron

      Comment


        #18
        Ed Wirth, Geron

        He's the medical director at Geron, going to talk about preclinical and phase 1 development of clinical trials.

        ED:

        I'm just getting over a cold, hopefully my voice will hold out. Thanks for the chance to give you an update on the trials . . .

        Starting with a review from what he told us at w2w 3 years ago. How do embryonic stem cells work?

        We funded the development of hesc's labs in the 90's. We paid James Thompson's lab at the university of Wisconsin to figure out how to use discarded embryos to to extract the stem cells . . . every single cell we have came from that very first embryo.

        No embryos have been used since then to create any of our stem cells.

        What do want to make with stem cells? Heart cells, cartilage, neural cells --

        We have a central manufacturing facility at Geron, wemultiply the starting materiial, we differentiation, and we preserve for transplantation.

        Our product is called grnopc1. showing a picure of a little vial; it's just medicine . . . (I'm having a moment here, thinking about how long I've followed the story of this product.)

        It takes 42 days and 4 steps to turn a stem cell into an opc, using a process developed in Hans Keirstead's lab at UC Irvine. Then there's a huge range of tests to make sure purity has been preserved.

        Talking about the nature of the injury and how opc's are not a magic bullet and not meant to be. opc's remyelinate surviving axons, which makes the axons better conductors; they also support regeneration of axons, which they saw in the lab at 9 months after transplantation -- has a slide up showing "a sea" of human matter in the middle of the damaged place in the rat's cord. That could only be there if the opc's had somehow stimulated it, because this was a rat cord.

        this means that the opc's are somehow allowing not just remyelination but regeneration . . . ahhhh, he talks like 3 times normal speed! I'll get him in the panel and in the workshop.

        opc's have not migrated to where they don't belong, and they haven't seen any evidence of any abnormal cells anywhere, for up to 12 months later.

        what about immunosuppression to reject rejection of the cells? it turns out that opcs don't cause much of an immune reaction.

        going over the history of this study, from march of 2008 to today.

        Now have centers open in Chicago, Atlanta and (soon) San Francisco. They're doing patients there, and will be doing follow up at 1 year, and long after that.

        There will be 8-10 subjects, asia a complete, T3-T10, 18-65 years old

        He just said that with some of the new scar tissue treatments coming out, together with our evidence that the cells promote regeneration,

        Showing a picture from the operating room at the Shepherd Center in Atlanta, where the first cells were given to the first patient on October 8 2010, NO HARMFUL SIDE EFFECTS TO DATE.

        The FDA has imposed a 30-day stagger, meaning that they are currently enrolling the second person. Jeez.

        Comment


          #19
          Panel One

          Wise, Ed Wirth, Anthony Caggiano from Acorda, and Leif form the Norwegian SCI group . . . Sue is introducing them.

          Question: Wise, I'm curious about the clinical trials? Are you doing human clinical trials?

          Yes, unfortunately I spent too much time on 101 and didn't get enough to talk about the trials. We're currently on our 5th phase, and we're doing patients with an escalating dosing trial . . . cord blood cells, lithium, methylprednisolone. We had a glitch with GMP standards and had to hire a consultant to come in and examine all our steps. We're expecting word that we're in complete FDA compliance. If it's all good, our first case will be on November 29th and then will do 2 to 4 cases per week. We also have permission to do it in parallel in China.

          We're looking at our Phase II trial in Austin TX next April. Toward the 4th quarter of 2011, we'll try to have trials going simultaneously in China, India, Norway, and the USA.

          Leif: as a user of this research, I have some questions . . . chronic spinal cord injuries??? In Norway we have an infrastructure in place, everybody is ready, but . . . how do we speed up the process of getting a trial going where we are? Also, for Ed Wirth, your cells look to be promising for chronics . . .how good are those neurotrophic factors from opc's compared to the others, assuming that scar tissues could be dealt with?

          Wise: Leif, you're doing the right thing, putting pressure on me and everyone. We started with nothing in China, except the good will of the doctors. I was commenting to some friends recently because even if everything stopped, we'd still have done an incredible thing there. We established standards of care, and we got everybody to buy into the concept of running clinical trials. We have to break through the regulatory barriers, which are worse than in the USA. Here, they have to give you a reason for their decisions within 3 months. In China, it's 3 years. Nobody has ever done clinical trials there, ever. I'm now traveling 350,000 miles every year, going to China twice a month. What I want to do there and everywhere is to find somebody local who can drive the network. In China that's Wendy; you must have someone who can run the network. Leif, you're the Wendy in Norway. I hope that in January we can set some milestones for a trial there. Keep doing what you're doing. Put pressure on us. Come to these meetings. Make us wake up every morning and think, "Norway, Norway!"

          Ed: My clinical team has been doing all the work -- that's me and two people getting all the permissions. We have to rely on outside people to do a lot of the work. Things take a long time because there's so much work to do . . . our working hypothesis is that the scar tissue that forms is the biggest barrier to opc's working on sci. Hans tried to genetically modify the cells to make them do both remyelination and scar destruction, but that didn't work out . . . we all know now that it's going to be a matter of figuring out as fast as possible how to time and combine things.

          Question: Do you monitor physiology of the cells in your trial patients, do you

          Ed: When people have sci surgery, they attach electrodes to the head and the legs and monitor potentials between head and the legs. However, in the cases we're doing, there are no potentials to monitor. There's a paper that shows evoked potentials are not present in many people who have incomplete injuries. With regard to tracking the cells . . .how do you do that? You need some kind of label, or you need to genetically modify them so they express something that can be seen in MRI. We don't have that yet, Changing our product now would mean re-doing all those clinical safety studies.

          Question:
          Wise, what can you tell us about the EXCell event in Germany?

          Wise: I only know from the internet that a child died from having cells injected. The parents are suing the company. The company was set up to take advantage of a loophole in German laws that allows autologous cells to be injected. There have been no safety studies, and I have been advising patients not to have this done.

          Question:
          Ed, what's the diff between acute and chronic?

          Ed: Acute means within 24 hrs at the absolute max . . .2 is better. Subacute is the secondary damage period, when scar tissue is forming. In rodents it goes out to a month. GEron did not see benefit in rats more than 2 months out, which is why we didn't think it worthwhile to try our cells in human chronics.

          Wise: Chronic is 1 year of no change. Our patients will be 18 - 65 years old.

          Leif: Asks what is Acorda's plan

          Anthony: We started out with some pretty large scale failures in our attempts to help with sci. We've done well with MS, and it's not appropriate for me to comment about how ampyra works for sci patients. We're still very interested and devote a lot of time and money to sci.

          Comment


            #20
            Rachel on Advocacy

            She works for Ogilvy, and is a former staffer at the Reeve Foundation. She came to us and taught us how to lobby -- she also took on every last task we asked her to during our events in DC.

            She says: I've been with u2fp for the last 4 years, and have seen this group grow from just a few determined women to 4 determined women, then 5 determined women, then -- well you see what's happened if you look around you.

            She invites JenJen and Martin Codyre up on stage, and then asks everyone to write down the reason they're here at w2w . . . Tim says he's excited to learn about the new technologies that are going to help us all. One of the Norwegians says that he's here to learn, and to justify the way they've been asked to spend their organization's money. Woman says knowledge is power . . .I'm here for my son. We have to educate the world about what paralysis truly is. Stephen Davies says he's here to share some new developments about both acute and chronic injuries. Science does work.

            RAchel: So that's a good cross section; for myself, I'm here to cure paralysis. I want to see therapies. I look around this room, and everybody knows that's not going to be easy. I don't often say this, but I suffer from paralysis, too. There's a couple different kinds. Wise told us about one kind in sci 101 . . . but there's also the paralysis of mind. Apathy, fear, laziness, procrastination, whatever. Sometimes we don't do what we would like to do.

            What's the cure for that?

            At u2fp, our mission is to unite all those affected by paralysis, and to empower them to fight. Unite 2 Fight.

            Everybody here has overcome paralysis of mind. What I think the cure for that is lives in one word: Advocacy. Today we are the community of advocates. That's extreme power. We should all be feeling it, and when we leave here we need a plan. It's up to every one of us to figure out how to fight this fight in our own way.

            Pick up your pen again . . . write down I . . . . . am . . . . . curing . . . . paralysis. She takes her mike out into the audience and asks people to speak the words. (They do, repeatedly. It's strangely powerful.) She says, I looked at myself in the mirror today and said those words, and -- wow. I'm doin' somethin' today. We're handing out toolkits now.

            Our goal for each of you is to be able to do one act of advocacy. If you're one of those people who's already doing stuff, then make it your goal to get one person besides yourself to do something.

            What's an advocate? somebody who won't give up, and won't shut up -- somebody who does any small thing that turns what IS into what COULD be.

            We identified 3 kinds of advocates -- Community, Media, and Legislative. It's an act of advocacy to say I was in Phoenix curing paralysis. Who's the model for a community advocate? That would be our badass friend Joe White.

            How about Media? That's somebody who knows how to use media to amplify their own voice -- social media, newspapers, magazines, music, youtube, etc. He can be heard!

            How about Legislative? This is somebody who likes to be the boss . . . the fact is that the people who work in DC are your employees. They respond to your agenda, and if they don't you fire them. As a good manager, you need to set their direction and if they don't follow it, you fire them. You have to tell them what to do, and you have to check back in with them to make sure they're doing what you told them.

            The idea here is that tomorrow, you'll get a chance to pick one of these ways to advocate. I'll show you exactly how it's done. The other two people I have up here are experts in the fundraising side of things -- both in the community and in the corporate world.

            Introduces Martin Codyre, from Ireland. Injured 2 years ago, has spent most of his time since then researching what the future holds. When I heard that paralysis can be cured, I started passing that word to my own community. People do want to help us, but they don't know how.

            I go up and give the First Annual Kick Ass Advocate award to our friend Karen Miner -- who is a truly great example of how to work with what you've got to help cure paralysis. She was injured 28 years ago, (c5) and was a single parent of two little girls. She took it upon herself to start raising money, and some of that money went to Hans Keirstead's lab at UC Irvine. I tell the group that the Geron trials Ed Wirth talked about began in Keirsteads' lab . . . which means that this woman directly helped to make the first ever human embryonic stem cell trials a reality. That's kickass.
            Last edited by t8burst; 5 Jun 2011, 12:49 PM. Reason: privacy

            Comment


              #21
              Afternoon sessions: Phil Horner

              Sue is introducing our buddy David Zach, father of three, u2fp board member, and c5-injured rock star advocate.

              David introduces Phil Horner, who's making his first appearance at w2w.

              Horner is youngish and wearing a dark suit with purple shirt . . . shows us a slide of the space needle (home!) now a pic of his daughter on her first day of first grade, beaming.

              He says he feels like her -- wild with excitement and also knowing that it's only first grade, the state of his lab.

              Outline:
              sc stem cells are active throughout life
              endogenous stem cells contribute to sc repair
              transplanted stem cells improve function following acute injury
              how do we recreate the post-injury period of repair in the chronic condition?

              Brain cells are replaced in select areas of the brain; but that declines a lot as you get older. This means that your own brain is plastic, in the sense that it's changeable and capable of growth.

              In the last 10 years, it's also been learned that spinal cord cells are replaced throughout life. Your cord does NOT create neurons, but it does create glia ("glue" cells) -- glia are involved in plasticity and in making connections. This is good news. As you get old, the pace at which glial cells replace themselves gets faster -- the opposite of what happens to neurons in the brain. We all lose myelin as we age, but our glial cells are replacing it.

              So, damn. Why don't these cells replace axons. There are some organizations that regenerate things super well. Pic of a starfish, which can regenerate a whole arm . . . also an arm can grow into a whole new body.

              Salamanders can regenerate limbs . . . you can take a limb bud and stick it on the salamander's head, and it will grow that limb out of the head.

              They also regenerate their spinal cords, right from the get go.

              What happens in mammals? Our injured cords generate glia almost exclusively . . . we don't make neurons. Some of the glia are helpful b/c they make myelin, some are life-sparing but they mess with return of function.

              Repair can be done. It's most likely an engineering problem at this point.


              Stem cells replace glia after sci . .. especially when injected early after injury. Chronic injuries don't benefit as much as we need them to.

              Sam Nutt is a researcher who's working on "the magic brew" induced pluripotent stem cells. (known as iPS cells). What they did was figure out which genes make an embryonic stem cell what it is. The genes are already there, but they're "turned off" -- if you could turn 'em back on, you could put them into an adult skin cell and reprogram it to turn it into an embryonic stem cell.

              Your adult skin cell can be turned into one of the stem cells that made you in the beginning. That stem cell can then be induced to become other kinds of cells, including cells from the nervous system. It takes 9 days to take cells that were skin cells and turn them into cells with properties of neurons.

              Sam . . . Sam could be our new best friend. Sam has been working on turning those iPS-created cells into the right kinds of neural glia. They have to look at thousands of genes and make sure they're switched on and off in exactly the right combination.

              Now have a phase 1 iilot study for preclinical trial with ips-derived glial precursors for chronic lesions of sci.

              (Preclinical means rats.)

              On the forelimb reaching task, you measure how well the rat can reach out and grab a pellet. They took human skin cells, turned them into glial cells, and put them into the rat. A month out from injury, they put the cells into the rat, it did have dramatic improvement, which disappeared with immune system protection withdrawn.

              They'll be producing patient specific cell lines under GMP conditions
              They'll find out if stem cells create a zone of plasticity
              They'll figure out how to collaborate with other scientists . . .

              Comment


                #22
                Stephen Davies, Local Hero

                Controlling scar formation and making the right kind of astrocytes.

                Spinal cord pathways . . . Stephen always has beautiful slides, but too full of information to do justice this quickly in words. Please check out the video of his talk when we get it up.

                He's saying that the contusion fills with astrocytes and macrophages.

                Sadly.

                What are the reasons we don't regenerate our damaged cords? Some theories:

                old neurons lose ability
                no growth support
                myelin is inhibitory to growth
                there's scar tissue, a physical and chemical barrier

                Stephen is interested in the scar tissue phenomenon. There are all these things growing into the injury that act as "scar" . . . basically he's saying that they found that some of the stem cells already in the cord are preventing regeneration . . .which is why you'd want to be very careful what kind of cells you put in there.

                It's one thing to get axons to cross the injury site, but another to get them to form collatorals . . . little side branches.

                They have 2 major repair strategies
                one is to overcome scar and myeling inhiotors to promote axon growth
                promote specific types of astrocytes

                Showing a list of all the cell based sci therapies, starting with the nonCNS ones, like schwann cells, olfactory ensheathing eclls, esc and asc

                he's looking instead at cns cells . . 70% of cns cells are some kind of astrocyte

                are they good candidates?

                Well . . . they provide metabolic support for neurons, they maintain the blood spinal cord barrier, they bridge the injury site, they promote remyelination of axons, they promote formation of neural connections and growth of dendrites, they transmit calcium wave signals through astrocyte networks, they regulate synapse activity with gliotransmitters (think that last word is a new term invented in his lab) -- in short, astrocytes are essential components of brain and spinal cord neural networks.

                So, can we make the right kind of astrocytes?

                the path is:
                esc becomes neuroepithelial stem cell, which becomes glial restricted precursors, which become a couple of kinds of astrocytes -- they've made what they call GDAsBMP, which are the good kind of astrocytes.

                Plan to collaborate with Phil Horner to get a source of them through iPS --

                They used their GDAsBMP cells created fast, reliable axon growth. The other kind of astrocytes stops growth cold, as did plain old stem cells.

                Did the axon growth contribute to functional recovery? Absolutely, and quickly.

                Okay, so we heard that he was going to talk about suppressing scar formation. That gets us decorin.

                Chronic . . . what can decorin do to promote axon regeneration in the chronically injured spinal cord?
                Can you increase enzymes that break down scar tissue?
                Can decorin desensitize

                if you add decorin to adult sensory neurons , you see axon growth. Decorin promotes growth AND attacks the growth inhibitors.

                ongoing studies: testing human decorin and gdasbmp in chronic sci contusion sci models
                combining same with rehab
                develop same for human clinical trials.

                Panel: Davies, Horner, Bruce Hanson, JenJen

                Question: Is it really hard to make an iPS cell out of a skin cell?
                Horner: No, that's simple enough for anyone to do with a kit. What's very hard is to turn them into what you want them to be. Another issue is that the FDA doesn't want us to use viral vectors to do the iPS switch, which means we have to come up with another way.
                Last edited by t8burst; 5 Jun 2011, 12:50 PM. Reason: privacy

                Comment


                  #23
                  Panel.

                  Question: What can we in this room do to help you guys?

                  Davies: Funding. Bad economy, slow NIH = slower research.
                  Horner: NIH is the elephant in the room, and the squeaky wheel gets the grease, so squeak. Squeak.

                  Question: are iPS cells going to be able to help by going around the esc "ethical" argument? (quotes around ethical are mine -- sorry. I think the fact Geron has taken stem cells from a single blastocyst that was destined for the medical waste bag and turned those cells into a treatment for spinal cord injury speaks for itself. Editorial comment over.)
                  Davies: What people must remember is that our test for iPS generated cell types is those same cell types generated from ESC. ESC is the gold standard.

                  Question: why not use Decorin together with rehab on people now, while the complicated trials are being designed?
                  Davies: I have a nondisclosure agreement that prevents me from telling you about a breakthrough we made 6 months ago . . . we're focused on the very first quality, top of the line treatment for sci.

                  Question: what should we be doing now?
                  DAvies: keep doing rehab, even if nothing seems to be happening. you're keeping circuits alive and you're going to need them.
                  Horner: if i were designing a clinical trial, i'd be looking for a group of patients who had a similar profile, and that profile would include regular pt.
                  Davies: we're going to need to look at a good record from rehab so that we have something to measure against . . .

                  Comment


                    #24
                    I am so sorry we could not make it. Budget and time issues this year! Interesting stuff so far. I am a little concerned about the rehab./regular pt. issue. What if you can't afford this or your insurance does not cover it? What if you don't have access to pt. for sci? That is going to exclude me from trials?

                    Thanks again for doing this Kate.

                    Comment


                      #25
                      Breakout Ed Wirth

                      The FDA said that for safety, a year followup is not long enough, and we agree.

                      They had a woman in a different trial who missed her 6 and 12 month follow up visits, and died at 23 months (this was NOT an esc trial or an SCI trial -- it was a parkinson's trial)

                      The FDA generally give you a problem, asks for your proposed solution, then lets you know if that's okay.

                      What if the patient moves? They have to live within 2 hours of the center to get in. Also they've signed an informed consent form. Here are the risks, there are no known benefit to humans, etc.

                      We give them 24 hours and then talk with them about all the issues. Every one of the centers is also allowed to modify the standard consent form as they see fit. if someone in Austin got injured tomorrow, they couldn't sign up for the trial until they were already inside the hospital site there.

                      We'd like to know if our cells are efficacious at one month. We'd like to be able to give patients that much time.

                      Are there exclusion criteria? It's up on clinicaltrials.gov, and as new sites are opened up, they'll be listed. Shepherd Center doesn't want to be listed there for fear that they'll be inundated with patients wanting to be in the trial.

                      Richard Kessler at Northwestern has been helping us -- as long as 3 years ago we talked about the hardware issue. One way to deal is to place rods laterally instead of medially; another is not to use cross connectors; another is the way they put the screws in. Those simple things can make the patient a candidate. We're working through our surgeons to get the word around.

                      MP really does work when given very early and in very high doses; sadly it has a bad rap. One of the things we don't talk much about is that even after an injury lots of white matter is intact, and that means doing injections can cause damage due to bleeding.

                      The tissue damage is due to bleeding. Your cord is irreversibly damaged by bleeding, unlike your muscle, which just bruises.

                      The secondary injury cascade begins when all those cells die, and lots of chemicals are released. They're what kill of the oligodendrocytes. It's like when a nuclear bomb goes off . . . if you're near you're dead, but if you're a distance away you'll survive a week or so before the radiation gets to you.

                      Michael Fehlings in Toronto has been running a large scale trial that shows it's best to decompress within the first 24 hours if you can.

                      How much time has been saved by the Geron trial? The main thing is not screwing it up. Something like that has already happened in stem cell research . . . Israeli boy who went to Russia, e.g. The main thing we can do is prove that there's no danger.

                      Other companies may not have to play the 3-year guessing game with the FDA.

                      Probably not.

                      Comment


                        #26
                        Originally posted by momo3 View Post
                        I am so sorry we could not make it. Budget and time issues this year! Interesting stuff so far. I am a little concerned about the rehab./regular pt. issue. What if you can't afford this or your insurance does not cover it? What if you don't have access to pt. for sci? That is going to exclude me from trials?

                        Thanks again for doing this Kate.

                        I just asked Phil Horner that question . . . he says in a perfect world, clinical trials, everyone who is chronic would get a six-month standardized therapy BEFORE they get enrolled. The main thing would be for people to take advantage of whatever is available to them and whatever they are able to do.

                        I'd be glad to do a followup if you have one.

                        k

                        Comment


                          #27
                          Breakout Phil Horner

                          How are you going to do standard rehab after a trial?

                          There's a hot debate about what's appropriate care in terms of rehab. The primary goal would be to have something standard. You'd want every patient to be doing a routine and not to change that routine after injection of cells.

                          When we go to efficacy, it's going to be really critical that we do the trials well, and honestly right now everybody is thinking about safety of cell transplants and not so much controlling the rehab.

                          Woman says that she just went to a neuro rehab conference at the Shepherd Center and everyone is saying that both human and robotic training are effective, but only robotic training allows them to measure. And measurement is what shows efficacy, nothing else.

                          And what about emotional health? How are you going to manage those or even know about what impact they have or don't have? The Parkinson's trials have been all over the place in terms of results, and part of that has to do with how hard it is to control all the things that would have to be controlled.

                          Question about access . . . can't do it if there's no place. Shouldn't there be a whole network of little strip mall exercise places like Curves, where people could pay some minimum amount to be assisted?

                          That would be amazing.

                          Talking now about the Portugal surgery. Phil has asked the people in the room with sci to talk about their own decisions. Two people with 2-3 year old injuries say that they thought about it seriously. One of them tells a story about a friend who did go there and came home with an injured arm.

                          man with new injury talks about going right to project walk, and his exercise regimen after that.

                          Says that he was thinking of going to India or China or Mexico but chose to come here to w2w instead . . . now after listening all day has decided against going at all.

                          Phil says that people don't realize anyone who has had any sort of non-FDA approved cell-based therapy has just added 10 years to the earliest date at which they can take advantage of new therapies. The reason is that they won't be eligible for a clinical trial of any kind, which means waiting for the full FDA approval, whenever that occurs.

                          Comment


                            #28
                            Originally posted by Leif View Post
                            Thanks Kate - greate report. See you all tomorrow
                            Leif,

                            I am sorry I could not make it out to AZ for coffee..I hope you have a wonderful time!

                            Mary
                            1FineSpineRN

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                              #29
                              A few photos from W2W

                              The first is me and Leif
                              The 2nd is Kate blogging
                              The third is Leschinsky and her friends Jub with Dr. Young
                              "Hope is like a road in the country; there was never a road, but when many people walk on it, the road comes into existence." Lin Yutang

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                                #30
                                I was there. It was great. There was so much information I couldn't even get it all. Dr. Young and I chat on Facebook quite a bit so it was really nice to actually meet him. I went up to him and he looked at me and I said hello and put my hand out to shake his hand, and instead of shaking my hand, he gave me a big hug and immediately started talking to me like we had been friends for ages. It was really nice. He explains spinal cord injury in ways that I never thought of it. After the main conference, I went in for a smaller more personal conference where he explained that he doesn't believe in the scar tissue problem because the way he put it was that a lot of clinicians cut the spinal cord which ends up leaving scar tissue and rarely is any of our spinal injuries cut. It was really interesting. I'm going back tomorrow. Now that I know who everyone is, maybe I can meet you guys somewhere after the conference.
                                C-5/6, 7-9-2000
                                Scottsdale, AZ

                                Make the best out of today because yesterday is gone and tomorrow may never come. Nobody knows that better than those of us that have almost died from spinal cord injury.

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