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    #61
    Originally posted by kivi66 View Post
    Dr.Wise,It's not negativity or positivity,but criticism.Not that I have right to criticise you,just possibility,provided by you,I realise that.And what I want that you provide too is evidence of success,achieved by you or your people in restoration structure and functionality some relatively big mammal's chronically damaged spinal cord.Without such evidence all human trial's expectations not more than speculation.And I have two questions.When do you suppose will be published work done by Kai Liu and whether you planning practical appliance of this finding in human trials? Thank you.
    kivi66,

    You can of course demand that all therapies be tested in large animals before they are tested in human clinical trial but I don't think that you know what you are talking about. You obviously have never taken care of a spinal-injured animal and have no idea of what is involved in doing large animal studies. Monkey studies are as or more expensive than doing human studies. Although several groups are trying, there are currently no large animal (i.e. monkey, dog, cat, pig, sheep) model of spinal cord injury that have been validated for efficacy assessment. What you are advocating will make preclinical studies much more expensive and slow down progress in the field.

    Although there use to be more large animal studies (I use to do all my work on cats), large animal spinal cord injury studies are rare today. To my knowledge, there are only two laboratories in the world currently doing monkey spinal cord injury experiments today (Almudena Ramon-Cueto) and Dr. Xiao-ming Xu from the University of Indiana doing the experiments in Shishanbana in China. There is one group trying to do a pig spinal cord injury model in the United States and that is in Shriner's Hospital in Philadelphia. I believe that there are only two groups in the United States doing cat spinal cord injury experiments. Large animal studies, if they are done at all, are usually for one purpose alone and that is to establish the safety of the therapy. For that purpose, for example, there are commercial companies that do dog or monkey experiments. These for-contract companies charge a great deal for these studies and the goal is often to show that the cell transplants do not cause cancer or other toxic effects.

    What is your goal? Is your interest in tearing down the clinical trials that we are planning to do? Why? Do you have something else that you think is worthwhile testing? Is so, let's hear it. You are being excessively negative.

    Wise.

    Comment


      #62
      I understand his concern, but hardly any research is done on large animals anymore. It would seem to me, that they have studied mice for so long that they would know which parts of the mice anatomy most closely replicate humans.I believe there is a primate research Center at UCSD and that someone was doing research with primates and SCI. But what I have read about the primate research Center there is that it is ridiculously expensive to test on primates, with a large portion of the expenses coming from security costs. They constantly have animal rights protesters there.

      Comment


        #63
        Originally posted by kivi66 View Post
        Dr.Wise,It's not negativity or positivity,but criticism.Not that I have right to criticise you,just possibility,provided by you,I realise that.And what I want that you provide too is evidence of success,achieved by you or your people in restoration structure and functionality some relatively big mammal's chronically damaged spinal cord.Without such evidence all human trial's expectations not more than speculation.And I have two questions.When do you suppose will be published work done by Kai Liu and whether you planning practical appliance of this finding in human trials? Thank you.
        Great. If you do want to do research, and research on other than humans, I for sure support you. Good research can be done. But, please report back youre findings. Thank you.

        Comment


          #64
          Leif,all what I can help is stabilize vertebra and remove bone fragments or herniated disk,but spinal cord itself is "terra incognita" for me.
          Dr.Wise,there were two questions at the end of my post,may I have answers?

          Comment


            #65
            Originally posted by kivi66 View Post
            Leif,all what I can help is stabilize vertebra and remove bone fragments or herniated disk,but spinal cord itself is "terra incognita" for me.
            Dr.Wise,there were two questions at the end of my post,may I have answers?
            Kivi66,

            The paper by Kai Liu has been accepted for publication and I hope that it will be coming out soon. I will post when it does. At the present, we do not have any plans to apply this therapy because it involves insertion of a gene with viruses and much work still remains to be done to ensure the safety of this procedure.

            Wise.

            Comment


              #66
              Originally posted by ChuckFoss View Post
              Dr. Young, thank you for explaining (once again) the details involved with the SCINetUSA clinical trials. Your patience and drive to help us understand and to get folks involved is extraordinary!
              This detailed explanation would be a great addition to the JustADollarPlease site. I think people are more apt to donate to a cause they can wrap their head around. The history and break-down of the trial phases was very informative. I know you've explained all this before, but having this amount of detail in one place on JustADollarPlease will help convince potentail donors who are on the fence.
              Thanks again.
              I second that.

              Comment


                #67
                Ditto on the thank you and suggestion of having this info on the JADP site.

                Comment


                  #68
                  same here
                  "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


                    #69
                    Wise, you have convinced or taught us that rat studies are necessary, Hopefully your human trials in Hong Kong surpass these animal trials. I belive that results of these trials will move the converstion to a new place. Your trials offer belief in the future for all of us. Let's hoep your trials will show real results and not comaprtive numbers. I know you know what some of us are looking for. Just get the studies going and put the rat conversations behind us.

                    Comment


                      #70
                      Originally posted by Wise Young View Post
                      Kivi66,

                      The paper by Kai Liu has been accepted for publication and I hope that it will be coming out soon. I will post when it does. At the present, we do not have any plans to apply this therapy because it involves insertion of a gene with viruses and much work still remains to be done to ensure the safety of this procedure.

                      Wise.
                      Dr.Wise,I have some more questions (lunasicc42,hope they are legitimate).What is your time estimation for completion work that "still remains to be done to ensure the safety of this procedure"? And this,I once talked to Dr.Samuil Rabinovich from Novosibirsk Immunotherapy Center(http://www.transplantation.ru) and asked him about his human trials with stem cells transplantation into lesion site in chronically injured spinal cord.What he answered is that there were not at all any improvements in patients' condition or it was very insignificant,and that financing of his program was canceled;he was especially pessimistic about possibility to repair demyelinated spinal cord.Info about results on internet site say different but Samuil Rabinovich himself is not there by now.What I want to ask you is may be you have more detailed information about what exactly was transplanted there and how your approach in your human trials will differ from his.Thank you.

                      Comment


                        #71
                        Originally posted by kivi66 View Post
                        Dr.Wise,I have some more questions (lunasicc42,hope they are legitimate).What is your time estimation for completion work that "still remains to be done to ensure the safety of this procedure"? And this,I once talked to Dr.Samuil Rabinovich from Novosibirsk Immunotherapy Center(http://www.transplantation.ru) and asked him about his human trials with stem cells transplantation into lesion site in chronically injured spinal cord.What he answered is that there were not at all any improvements in patients' condition or it was very insignificant,and that financing of his program was canceled;he was especially pessimistic about possibility to repair demyelinated spinal cord.Info about results on internet site say different but Samuil Rabinovich himself is not there by now.What I want to ask you is may be you have more detailed information about what exactly was transplanted there and how your approach in your human trials will differ from his.Thank you.
                        After finishing his PhD with me, Kai Liu joined a group at Harvard, headed by Zhigang He. They discovered that a gene called PTEN controls the ability of corticospinal neurons in the cortex to regenerate. If PTEN is knocked out or inactivated by other messengers such as mTOR, corticospinal tracts undergo robust regeneration. PTEN itself acts through other messenger systems such as GSK-3b. He's group has been working on manipualting mTOR. Our group has been working on GSK-3b which is inhibited by lithium (which also stimulates regeneration). At the end of this post, I attach a recent review article that was written by He's group.

                        I think that when you read the article, you can perhaps appreciate the complexity of manipulating the PTEN gene, which may do many things besides inhibit regeneration. We chose to study lithium because it has been used for many years to treat manic depression, has been shown to stimulate regeneration in the spinal cord by inhibiting GSK-3b, stimulates neural stem cells to proliferate, and activates umbilical cord blood cells to produce growth factors, and can be taken immediately to clinical trial.

                        Regarding Samuiel Rabinovich and why his OEG transplants are not producing significant motor improvement, he is transplanting fetal cells. These cells are not HLA-matched and are immune-rejected. In my opinion, this is the reason why OEG transplants from fetuses does not produce significant motor recovery in patients transplanted by Hongyung Huang. Lima tried to use autologous OEG cells from the nasal mucosa but I doubt very much that transplanted nasal mucosa are producing many olfactory ensheathing glial cells. In Brisbane, they grew olfactory ensheathing glia from nasal mucosa of two patients and transplanted the expanded cells into the spinal cord of these patients but did not see much effect. For four years now, Geoffrey Raisman in London has been trying to grow sufficient numbers of olfactory ensheathing glia from nasal mucosa without reliable success.

                        In our trial, we will be using HLA-matched umbilical cord blood. Such HLA-matched cells have been shown to engraft successfully when infused into patients to replace bone marrow. The cells have been safely used to treat thousands of patients since 1989. Joanne Kurtzberg at Duke University has shown that these cells can reverse genetic metabolic disorders in the brain when transplanted into children. Many animal studies suggest that umbilica cord blood cells secrete growth factors that stimulate regeneration and are beneficial when transplanted into the spinal cord of rats. We have shown that lithium stimulates these cells to proliferate and to secrete NGF, NT-3, and GDNF, three neurotrophins that have been reported by many investigators to stimulate regeneration in the spinal cord. Lithium itself, as pointed out above, stimulates regeneration in the spinal cord.

                        We chose to test umbilical cord blood and lithium because both therapies have long-established records of safe use in humans. Between 2-3% of people have manic depression and lithium is used in about half of them. So, lithium is one of the most widely used drugs in the world. Unlike OEG and even bone marrow cells, HLA-matched umbilical cord blood is readily available from cord blood banks around the world and can be rapidly used to treat thousands of people. The risks of the therapies are minimal compared to the potential benefits. We are working with Stemcyte, the best and most experienced commercial company providing umbilical cord blood for transplantation.

                        Wise.

                        Comment


                          #72
                          Thank you very much,Doctor,it was impressive.

                          Comment


                            #73
                            Have the people at SCInetUSA or anyone anywhere tried to start a text messaging fundraising campaign like they did for Haiti relief?

                            Comment


                              #74
                              http://www.mobilecommons.com/organizations/fundraising/


                              you have to be a nonprofit organization to do it, otherwise I would have already.

                              Everyone including us is so lazy that it's perfect.

                              Comment


                                #75
                                What if someone says...."here's 25 million"...can you make me walk again? How does that work? There are at least 20 im sure of people living with spinal cord injuries whose family's can afford to try to bring that to life.

                                Show on a video an animal recovering and it will be over.

                                I am sorry to be negative, but I just don't believe in a natural cure. I believe in robotic assisted devices in the future.

                                I am not convinced. Its not Dr. Wise...(i believe hes doing more than anyone) - its just the community as a whole is lost.....

                                Its just toooo MUCH!!! Either doctors and scientists have passion or don't.
                                Birds Fly in Flocks, but Eagles Fly Alone...

                                Comment

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