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    Originally posted by Wise Young View Post
    Pelican,

    I ask your opinion because I would like to know what you would consider to be a reasonably de-risked therapy that should go to trial. I respect your opinion as an investor. By the way, most spinal cord injury scientific advisors have never designed, organized, or participated in clinical trials, so I am not sure that their opinions are necessarily any more valid than yours. You (and others) have expressed the view here that any therapy that has not yet been tested in appropriate chronic spinal cord injury models should not be taken to clinical trial. There have been several groups that have been trying to say that clinical trials should be done only when specified criteria are met.

    I disagree that a therapy should meet some specified efficacy criteria before going to trial. It is already difficult enough to get therapies into clinical trials without some committee (usually a self-appointed committee with little or no experience with clinical trials) stopping therapies from going into clinical trial because somebody on the committee believes that a therapy does not work, that certain spinal cord injury models are not good, or other scientific politics. Yes, as I hope you and others here should have gathered, there is substantial scientific politics going on in spinal cord injury. There are many scientists pushing their own agenda, their theory, their treatment, and their model. They are competing with each other and they often have a lot at stake, including their reputation and funding.

    To get a therapy into trial, particularly in a non-profit network, one must convince literally hundreds of scientists, clinicians, investors, and patients that the therapy is worthwhile testing in preclinical studies, pursuade companies to donate the therapies, raise millions from skeptical organizations and donors, get regulatory approval from the FDA in the U.S. and regulatory authorities in other countries, get ethical and clinical approval from institutional review boards, and apply to dozens of funding agencies. Believe me, these are not trivial tasks and I don't think adding scientific politics to that burden is a good idea.

    Regarding clinical trials and risk, you are probably referring to risk of therapy proving to be not beneficial. I think of failure as a clinical trial that fails to provide credible data. For example, if ChinaSCINet shows definitively that umbilical cord blood mononuclear cells and lithium are not beneficial in chronic spinal cord injury, I would consider the trial a success. It means that we can close the door on umbilical cord blood mononuclear cell transplantation, which is already being practiced by clinics catering to medical tourists around the world. If the trial shows that umbilical cord blood mononuclear cells are beneficial, the trial would be even more successful. The only failure is if the trial were so poorly designed and conducted that we don't get a reliable answer one way or another.

    A review of how ChinaSCINet chose its trials illustrates that the situation is not as simple as you have suggested. In 2006, when we started the current series of trials for ChinaSCINet, the investigators of ChinaSCINet considered all the therapies that were available. We had several objectives:
    1. We wanted to prove to the world that we have a network that can carry out rigorous clinical trials rapidly and efficiently.
    2. We wanted to gain experience with testing of combination therapies in clinical trials.
    3. We wanted to test a cell therapy that is safe, readily available to the world if the treatment is effective, and that is already being used.
    4. We wanted a therapy that was safe. A trial that has to be stopped because of a safety issue means that we would have to start all over again.
    5. Of course, we wanted to have a therapy that would cure spinal cord injury.


    After reviewing all available therapies in 2006, we chose umbilical cord blood mononuclear cells and lithium because we thought these were the most promising, safe, and feasible therapies. Please note that neither of these therapies were discovered in my laboratory or "my" therapies in any sense of the word. My laboratory did not do the preclinical studies. As it is turning out, the choice of umbilical cord blood and lithium was a good one because phase II trials showed that the therapies are safe and have yielded interesting results that the group has decided to pursue. First, lithium seems to reduce severe neuropathic pain in people with chronic spinal cord injury and we are doing a phase III trial to confirm this unexpected finding. Second, umbilical cord blood mononuclear cells appear to stimulate growth of fiber bundles across the injury site of people with chronic spinal cord injury. Third, a surprising number of people are recovering locomotor function, albeit without early motor and sensory score changes. A phase III trial will confirm and convince the world that the treatment does or not does not have these effects. We could have also decided that the data that we have collected so far is not worthwhile following up and that we should start testing other therapies. Because it takes time to prepare therapies for trials, we are now seriously considering what therapy to test next after the planned Phase III trial is done. Believe me, there is no perfect therapy out there that is ready to go to trial. Should we wait? If so, how long?

    Wise.
    Dr Young, this is an absolutely tremendous post. Thank you very much for your explanation in your rationale for bringing your current trial to fruition. I agree 100% with your logic - the key to figuring out what will work is eliminating what will not work. We know air exists not because we see it, but we see the leaves move in the tree tops. As long as any trial lets us see the leaves move, it has value. Obviously some will be more valuable than others, but it seems we know so little, if we should be testing as much as we can.

    Pelican made an interesting point about limited resources etc and public vs. private funding. I do not believe that makes a difference. Everyone involved is motivated to prove their therapy works the best or is the best solution - less available money would logically mean that their evidential burden is high before it can be tested. Let it be so. I do not think anyone involved wants to go willy-nilly throwing money around - those that waste money will be proven out as poor scientists or managers.

    As long as we do not throw good money after treatments which we eliminate as not being useful to cure SCI, then I believe the system is essentially working properly. Certainly standing idly by is not an option and I think everyone agrees the time for that is over.

    Comment


      Originally posted by paolocipolla View Post
      Wise,

      if I understand you correctly here above you agree that the "lesion environment" in chronic SCI is still a major problem.

      If there is one thing that disturbs me deeply in SCI research is the fact that the "lesion environment" (the scar) in chronic SCI hasn't been studied deeply by more labs yet. We could be much closer to a cure if we knew precisely what molecules, cells etc. are present in the "lesion environment" in chronic SCI.

      Paolo
      Paolo,

      Of course I believe that the lesion environment is a major problem. I have never said that it is not. I said that I disagree with the use of the word "scar" to refer to the lesion environment. This does not mean that I think the lesion environment is not a major problem. I have spent almost my entire career studying the contusion model. It is the most difficult model to regenerate. I just think that trying to oversimplify the lesion environment as "glial scar" is wrong.

      There are many aspects in the contusion site that we haven't discussed, including the possibility that the astrocytic environment of the contusion site is too attractive (compared to the surrounding regions) for axons to leave. Jerry Silver did a great experiment many years ago that shows that axons that start out growing an inhibitory environment can grow in an inhibitory environment but it stops being able to do so when it comes into contact with an environment that facilitates growth.

      It is not true that the injury site has not been studied deeply by any laboratory. Many laboratories have studied the environment of the contused spinal cord, including some laboratories that have characterize the expression and time course of every gene and every protein at the lesion site. There is a lot of data but difficult to interpret. It is hard to know what every protein does in the context of the lesion. To prove cause and effect you need to remove the various proteins one by one, to see their effects. There are laboratories that are beginning to do this is genetic model systems, such as transgenic mice, transgenic zebrafish, and also lamprey.

      Wise.

      Comment


        Originally posted by paolocipolla View Post
        Wise,

        all these tasks above should become much easier if you have at least one animal study (in chronic SCI) that show efficacy of the therapy you want to bring to clinical trial, so I believe that to have a positive animal study is essential (but maybe not enough) to raise the money needed for a clinical trial.

        BTW I am an investor too since, as you know, I am putting time and money to help finding a cure for chronic SCI.

        Paolo
        No, Paolo. Most of these tasks have been already accomplished for testing umbilical cord blood cells and lithium. You haven't helped.

        Instead of being so negative, perhaps you can answer the question that I asked Pelican. What therapy would you suggest?

        Wise.

        Comment


          Originally posted by cripwalk View Post
          Dr Young, this is an absolutely tremendous post. Thank you very much for your explanation in your rationale for bringing your current trial to fruition. I agree 100% with your logic - the key to figuring out what will work is eliminating what will not work. We know air exists not because we see it, but we see the leaves move in the tree tops. As long as any trial lets us see the leaves move, it has value. Obviously some will be more valuable than others, but it seems we know so little, if we should be testing as much as we can.

          Pelican made an interesting point about limited resources etc and public vs. private funding. I do not believe that makes a difference. Everyone involved is motivated to prove their therapy works the best or is the best solution - less available money would logically mean that their evidential burden is high before it can be tested. Let it be so. I do not think anyone involved wants to go willy-nilly throwing money around - those that waste money will be proven out as poor scientists or managers.

          As long as we do not throw good money after treatments which we eliminate as not being useful to cure SCI, then I believe the system is essentially working properly. Certainly standing idly by is not an option and I think everyone agrees the time for that is over.
          cripwalk,

          Thank you for your comments. I agree very much with what you say.

          Wise.

          Comment


            Originally posted by crabbyshark View Post
            You've flippantly blown off the idea that ibuprofen could somehow help you despite scientific evidence suggesting that ibuprofen inhibits RhoA and your own admission that you've had return over the years while taking hundreds of bottles of Motrin. Correlation does not equal causation (which is why there are clinical trials) but I would think you'd be more considerate than that.
            You read but did not comprehend. The Motrin was taken LONG AFTER I had a patch of sensation come back.
            Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.

            T-11 Flaccid Paraplegic due to TM July 1985 @ age 12

            Comment


              Originally posted by Wise Young View Post
              Pelican,

              I ask your opinion because I would like to know what you would consider to be a reasonably de-risked therapy that should go to trial. I respect your opinion as an investor. By the way, most spinal cord injury scientific advisors have never designed, organized, or participated in clinical trials, so I am not sure that their opinions are necessarily any more valid than yours. You (and others) have expressed the view here that any therapy that has not yet been tested in appropriate chronic spinal cord injury models should not be taken to clinical trial. There have been several groups that have been trying to say that clinical trials should be done only when specified criteria are met.

              I disagree that a therapy should meet some specified efficacy criteria before going to trial. It is already difficult enough to get therapies into clinical trials without some committee (usually a self-appointed committee with little or no experience with clinical trials) stopping therapies from going into clinical trial because somebody on the committee believes that a therapy does not work, that certain spinal cord injury models are not good, or other scientific politics. Yes, as I hope you and others here should have gathered, there is substantial scientific politics going on in spinal cord injury. There are many scientists pushing their own agenda, their theory, their treatment, and their model. They are competing with each other and they often have a lot at stake, including their reputation and funding.

              To get a therapy into trial, particularly in a non-profit network, one must convince literally hundreds of scientists, clinicians, investors, and patients that the therapy is worthwhile testing in preclinical studies, pursuade companies to donate the therapies, raise millions from skeptical organizations and donors, get regulatory approval from the FDA in the U.S. and regulatory authorities in other countries, get ethical and clinical approval from institutional review boards, and apply to dozens of funding agencies. Believe me, these are not trivial tasks and I don't think adding scientific politics to that burden is a good idea.

              Regarding clinical trials and risk, you are probably referring to risk of therapy proving to be not beneficial. I think of failure as a clinical trial that fails to provide credible data. For example, if ChinaSCINet shows definitively that umbilical cord blood mononuclear cells and lithium are not beneficial in chronic spinal cord injury, I would consider the trial a success. It means that we can close the door on umbilical cord blood mononuclear cell transplantation, which is already being practiced by clinics catering to medical tourists around the world. If the trial shows that umbilical cord blood mononuclear cells are beneficial, the trial would be even more successful. The only failure is if the trial were so poorly designed and conducted that we don't get a reliable answer one way or another.

              A review of how ChinaSCINet chose its trials illustrates that the situation is not as simple as you have suggested. In 2006, when we started the current series of trials for ChinaSCINet, the investigators of ChinaSCINet considered all the therapies that were available. We had several objectives:
              1. We wanted to prove to the world that we have a network that can carry out rigorous clinical trials rapidly and efficiently.
              2. We wanted to gain experience with testing of combination therapies in clinical trials.
              3. We wanted to test a cell therapy that is safe, readily available to the world if the treatment is effective, and that is already being used.
              4. We wanted a therapy that was safe. A trial that has to be stopped because of a safety issue means that we would have to start all over again.
              5. Of course, we wanted to have a therapy that would cure spinal cord injury.


              After reviewing all available therapies in 2006, we chose umbilical cord blood mononuclear cells and lithium because we thought these were the most promising, safe, and feasible therapies. Please note that neither of these therapies were discovered in my laboratory or "my" therapies in any sense of the word. My laboratory did not do the preclinical studies. As it is turning out, the choice of umbilical cord blood and lithium was a good one because phase II trials showed that the therapies are safe and have yielded interesting results that the group has decided to pursue. First, lithium seems to reduce severe neuropathic pain in people with chronic spinal cord injury and we are doing a phase III trial to confirm this unexpected finding. Second, umbilical cord blood mononuclear cells appear to stimulate growth of fiber bundles across the injury site of people with chronic spinal cord injury. Third, a surprising number of people are recovering locomotor function, albeit without early motor and sensory score changes. A phase III trial will confirm and convince the world that the treatment does or not does not have these effects. We could have also decided that the data that we have collected so far is not worthwhile following up and that we should start testing other therapies. Because it takes time to prepare therapies for trials, we are now seriously considering what therapy to test next after the planned Phase III trial is done. Believe me, there is no perfect therapy out there that is ready to go to trial. Should we wait? If so, how long?

              Wise.
              Thanks for your comprehensive reply Wise.

              I agree that the advisory boards are often so political that they end up choosing "nothing" by default. This is definitely an issue that needs to be resolved.

              I agree that advisory boards must be suitably skilled members with academic, pre-clinical, clinical and commercial backgrounds. A balance is vital. Patient representation would also be useful if possible. Perhaps members of advisory boards should be asked to "reapply" for their membership on an 24-month basis? It is after all an honour to serve on a scientific advisory board.

              I agree that clinical trials are incredibly tough to execute. I think everyone appreciates the incredible amount of hard work that has been put in to make this a reality.

              I agree that the success of a trial should be measured by robustness of the data produced ie reliable answers either way. I understand your theory of 'elimination'. There's nothing wrong with it 'in theory'. However, in reality, to sustain a non-commercial trial network that relies on funding from supporters affected by chronic SCI you may only have a finite number of chances before the faith and support is lost. We are a fickle bunch unfortunately At the same time, although China has a large population of SCIs - the number willing to take part in trials is still finite. Will participants continue to sign up in sufficient number when the network has a track record of multiple trials without 'success in their eyes'? Something to consider.

              We know that combination therapies are incredibly complex to plan clinical trials for. And I, like everyone here, want to see therapies racing through the pipeline. But, as an 'investor' who has to tirelessly interface neutrally with dozens of hungry scientists all competing, politicking, bamboozling and sniping, I'd personally like to see an additional step in the pre-clinical work for combination strategies. This way we may see at least one or two more of the dozens of scientists agreeing that the therapy is sound for clinical trial. And that would make me more confident in my 'investment' ie de-risked. Of course, it could still fail - but that's risk management.

              In terms of therapies to take to trial - well, there is one therapy that everyone seems to be sitting on their hands about. And everyone in the field seems to be OK that one commercial entity can hold it's potential in the pipeline when there is enough data to show that breathing in chronic injuries could be restored. And yes, there is a human-grade version of the agent available elsewhere. That's a crying shame - actually, that's a travesty for those on ventilators!

              Comment


                Originally posted by Fly_Pelican_Fly View Post

                In terms of therapies to take to trial - well, there is one therapy that everyone seems to be sitting on their hands about. And everyone in the field seems to be OK that one commercial entity can hold it's potential in the pipeline when there is enough data to show that breathing in chronic injuries could be restored. And yes, there is a human-grade version of the agent available elsewhere. That's a crying shame - actually, that's a travesty!
                Well said. And it is a travesty if not a human rights issue.
                Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.

                T-11 Flaccid Paraplegic due to TM July 1985 @ age 12

                Comment


                  Wise, what is holding back the use of chondroitinase in your future plans? Do you think the hundreds of positive pre-clinical results at acute stages as well as positive results now in several long chronic models aren't sufficient?

                  Comment


                    Originally posted by Fly_Pelican_Fly View Post
                    Thanks for your comprehensive reply Wise.

                    I agree that the advisory boards are often so political that they end up choosing "nothing" by default. This is definitely an issue that needs to be resolved.

                    I agree that advisory boards must be suitably skilled members with academic, pre-clinical, clinical and commercial backgrounds. A balance is vital. Patient representation would also be useful if possible. Perhaps members of advisory boards should be asked to "reapply" for their membership on an 24-month basis? It is after all an honour to serve on a scientific advisory board.

                    I agree that clinical trials are incredibly tough to execute. I think everyone appreciates the incredible amount of hard work that has been put in to make this a reality.

                    I agree that the success of a trial should be measured by robustness of the data produced ie reliable answers either way. I understand your theory of 'elimination'. There's nothing wrong with it 'in theory'. However, in reality, to sustain a non-commercial trial network that relies on funding from supporters affected by chronic SCI you may only have a finite number of chances before the faith and support is lost. We are a fickle bunch unfortunately At the same time, although China has a large population of SCIs - the number willing to take part in trials is still finite. Will participants continue to sign up in sufficient number when the network has a track record of multiple trials without 'success in their eyes'? Something to consider.

                    We know that combination therapies are incredibly complex to plan clinical trials for. And I, like everyone here, want to see therapies racing through the pipeline. But, as an 'investor' who has to tirelessly interface neutrally with dozens of hungry scientists all competing, politicking, bamboozling and sniping, I'd personally like to see an additional step in the pre-clinical work for combination strategies. This way we may see at least one or two more of the dozens of scientists agreeing that the therapy is sound for clinical trial. And that would make me more confident in my 'investment' ie de-risked. Of course, it could still fail - but that's risk management.

                    In terms of therapies to take to trial - well, there is one therapy that everyone seems to be sitting on their hands about. And everyone in the field seems to be OK that one commercial entity can hold it's potential in the pipeline when there is enough data to show that breathing in chronic injuries could be restored. And yes, there is a human-grade version of the agent available elsewhere. That's a crying shame - actually, that's a travesty for those on ventilators!
                    Yep, let's get ch'ase into clinical trials as soon as possible while combinations with pTen knock out and nerve grafts etc etc are worked on in animal trials at the same time.

                    Comment


                      It may be a dead end but I'd also like to know how Raisman's OEG trials in Poland are progressing

                      Comment


                        Originally posted by Wise Young View Post
                        No, Paolo. Most of these tasks have been already accomplished for testing umbilical cord blood cells and lithium. You haven't helped.

                        Instead of being so negative, perhaps you can answer the question that I asked Pelican. What therapy would you suggest?

                        Wise.

                        Professor what is your opinion on epidural stimulation of Dr. Harkema louiseville in conjunction with your treatment to stimulate the spinal cord? and tell me your general opinion on the epidural stimulation of the spinal cord and I also wanted to know why the electrodes year positions at the lumbar level and not at the level of the spinal cord INJURY

                        Comment


                          Originally posted by jsilver View Post
                          Wise, what is holding back the use of chondroitinase in your future plans? Do you think the hundreds of positive pre-clinical results at acute stages as well as positive results now in several long chronic models aren't sufficient?
                          Jerry, as you know, I am a strong supporter of taking chondroitinase to trial. ChinaSCINet is ready to do so. Wise.

                          Comment


                            Originally posted by Fly_Pelican_Fly View Post
                            Thanks for your comprehensive reply Wise.

                            I agree that the advisory boards are often so political that they end up choosing "nothing" by default. This is definitely an issue that needs to be resolved.

                            I agree that advisory boards must be suitably skilled members with academic, pre-clinical, clinical and commercial backgrounds. A balance is vital. Patient representation would also be useful if possible. Perhaps members of advisory boards should be asked to "reapply" for their membership on an 24-month basis? It is after all an honour to serve on a scientific advisory board.

                            I agree that clinical trials are incredibly tough to execute. I think everyone appreciates the incredible amount of hard work that has been put in to make this a reality.

                            I agree that the success of a trial should be measured by robustness of the data produced ie reliable answers either way. I understand your theory of 'elimination'. There's nothing wrong with it 'in theory'. However, in reality, to sustain a non-commercial trial network that relies on funding from supporters affected by chronic SCI you may only have a finite number of chances before the faith and support is lost. We are a fickle bunch unfortunately At the same time, although China has a large population of SCIs - the number willing to take part in trials is still finite. Will participants continue to sign up in sufficient number when the network has a track record of multiple trials without 'success in their eyes'? Something to consider.

                            We know that combination therapies are incredibly complex to plan clinical trials for. And I, like everyone here, want to see therapies racing through the pipeline. But, as an 'investor' who has to tirelessly interface neutrally with dozens of hungry scientists all competing, politicking, bamboozling and sniping, I'd personally like to see an additional step in the pre-clinical work for combination strategies. This way we may see at least one or two more of the dozens of scientists agreeing that the therapy is sound for clinical trial. And that would make me more confident in my 'investment' ie de-risked. Of course, it could still fail - but that's risk management.

                            In terms of therapies to take to trial - well, there is one therapy that everyone seems to be sitting on their hands about. And everyone in the field seems to be OK that one commercial entity can hold it's potential in the pipeline when there is enough data to show that breathing in chronic injuries could be restored. And yes, there is a human-grade version of the agent available elsewhere. That's a crying shame - actually, that's a travesty for those on ventilators!
                            Thanks. We have agreement on many points. Let me comment on three issues that you raised:
                            Dearth of subjects if the network does not encounter success in the first trials. Of the hundreds of thousands of people with chronic spinal cord injury who would be eligible for clinical trial, I don't think that we will have trouble recruiting 240 of them for our upcoming phase III. While success in the first trial may attract more subjects for future trials, I am not sure that we want to attract subjects for that reason alone. People volunteer for the trials because they want to help their community identify therapies that restore function. We do our very best to choose the therapies that we think are safe and the most likely to restore function to them. We are committed to offering future trial options to people who have already participated in our trials. We will work together identify the most effective and safe therapies for the whole community. This is the best approach that we can take.
                            Achieving greater consensus amongst scientists for which treatment to take to trial. Who is this consensus for? Is it for the SCI community, companies, the regulatory agencies, clinicians, or the investors? If the consensus is intended for the investors, so that they will invest in the trials, the risk vs. profit analysis will probably proceed as follows. If investors can get regulatory approval on a product at a low cost, such as $12 million vs. industry standard of $2 billion, it would be a very attractive investment even if the risk of failure is relatively high. If the consensus is intended for companies who have potential products for trial, the knowledge that the trial will be done efficiently and rapidly for a limited investment would be more important than the promise of the therapy, which the company believes in anyway. If the consensus is for the SCI, scientific, clinical, and regulatory communities, it would be nice to have more support but the results of the trials will be the only things that matter and will speak louder than any pre-trial consensus. Should we be delaying trials for such consensus? Do you see any prospect of consensus amongst spinal cord injury scientists now?
                            Better risk management. What are the risks of clinical trials? Clinical trial risks fall into three categories: clinical trial execution, product safety, and treatment efficacy. Obviously, if the trials don't get executed well, the investment is wasted. A serious safety issue can kill a product (or worse, somebody). Even minor safety issues will make the product more difficult to approve and eventually to market. Treatment efficacy is of course important because an ineffective therapy will not receive regulatory approval. However, a robust mechanism of action is often considered more important than preclinical evidence of therapeutic efficacy in animal models because animal models don't always predict the human response and some therapies cannot be adequately tested in animals.

                            With regard to chondroitinase, please consider the following. Acorda Therapeutics has licensed a use patent for chondroitinase for spinal cord injury from James Fawcett and his colleagues. To my knowledge, Acorda does not hold the composition of matter patent, which is held by a Japanese food company that discovered the bacterial gene. They do not hold the processing patent, which was filed by another Japanese company (Seikagaku) that developed methods to isolate and purify chondroitinase. Neither of these companies have licensed their patents to Acorda. Seikagaku apparently has licensed its processing patent to another Japanese company. Also, both of these patents are relatively old and will probably run out in a relatively short time. Finally, several competing products may soon make chondroitinase enzyme obsolete as a therapy.
                            1. Jerry Silver has a small molecule drug, a polypeptide that can be given systemically to block the receptor that mediates the inhibitory effects of CSPG. I assume that it has been licensed to a company. There are reports that it is effective.
                            2. Emory University has patented a form of chondroitinase that is less heat sensitive and apparently more potent that the standard bacterial chondroitinase.
                            3. Several groups have successfully inserted chondroitinase into cells that then secrete the enzyme, so that these cells can be transplanted into the injury site and deliver chondroitinase locally at much less cost.
                            4. A human enzyme that breaks down chondroitin-6-sulfate-proteoglycans has been discovered.


                            I don't know how much these factors are influencing Acorda's decisions but they have said that they are doing safety and other studies to produce chondroitinase for trial. These studies are not trivial and require substantial work, investment, and time. I am sure that if a foundation said that they would be willing to fund a chondroitinase trial, it could be done.

                            Wise.
                            Last edited by Wise Young; 11 Feb 2013, 12:57 PM.

                            Comment


                              Originally posted by Wise Young View Post
                              Jerry, as you know, I am a strong supporter of taking chondroitinase to trial. ChinaSCINet is ready to do so. Wise.

                              So wise, can you get ahold of some chondroitinase as soon as possible?? any plans in the works?
                              "That's not smog! It's SMUG!! " - randy marsh, southpark

                              "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


                              2010 SCINet Clinical Trial Support Squad Member
                              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


                                Originally posted by 6 Shooter View Post
                                So, just how would you propose this be done on live humans?
                                6 Shooter,

                                I like your question!
                                My disappointment was directed to the fact that not even in animals the chronic lesion environment has been studied more intensively at chrinic stages. That would be the first step.

                                About humans one important thing to do is to do more histology studies of spinal cords of people with SCI when they die (if they agree to donate it to scienze).
                                At the same time you remember for sure about Carlos Lima procedure which included the removal of the "scar". That has been a great opportunity to study the human scar, I am not sure if it has been used as best as possible.
                                Now a similar procedure should be done in a clinical trial in New Zeland.
                                To analize carefully the tissue removed from the spinal cord it would be extrimely interesting I think. I hope it will be done, perhaps we should make sure of that.

                                Another important way forward is to develop better imaging technologies. In animals that could become as good as to replace histology.
                                Next step would be to use the same imaging in humans so that you have a precise idea of each leasion environment to take the most appropriate approach for every single case.

                                Just as an example here is one of the latest imagine technology: http://spinalcordresearchandadvocacy...ticle-imaging/

                                If you like chemistry here is a lab who has used a chemical approach to study the lesion environment:
                                http://chemistry.caltech.edu/~fucose/publications.html

                                I hope someone can add more info/ideas.

                                Paolo
                                Last edited by paolocipolla; 11 Feb 2013, 3:03 PM.
                                In God we trust; all others bring data. - Edwards Deming

                                Comment

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