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  • As SCI’ed and relatives one could choose to work for a SCI cure in different ways and arrays, sure… If a person or clinicians - and network admin wants to do it so or so, fine by me. But as said before, Wise has said this website should not become a promoting website for a particular advocating and promoting website – well; now in much comments by Dr. Young this place has become just that. A website for pressuring own opinions. Go to Italy Young J

    Comment


    • Originally posted by Leif View Post
      As SCI’ed and relatives one could choose to work for a SCI cure in different ways and arrays, sure… If a person or clinicians - and network admin wants to do it so or so, fine by me. But as said before, Wise has said this website should not become a promoting website for a particular advocating and promoting website – well; now in much comments by Dr. Young this place has become just that. A website for pressuring own opinions. Go to Italy Young J
      Leif, I am sorry that you feel this way and I disagree with you.

      If you want to push for the cure in your way, all the more power to you. But, if all you want to do is denigrate the work of others, please refrain. What you are doing is wrong.

      Take a look at the Cure Forum and tell me honestly whether you think that we have really pressured people and promoted the umbilical cord blood and lithium therapies. In fact, I have posted so little about the therapies here that people don't know very much about it.

      In contrast, there are multiple threads here about everybody's therapies, from Steven Davies, to X-cells and Geeta Shroff's cells, whatever they are. Every therapy from blue food dye to making rats walk automatically on treadmills has been hyped and discussed here.

      Where has umbilical cord blood cells and lithium been hyped on this site? Yes, it has been discussed but what hype are you talking about? Has there been any claim that the cells (at least from me) that the cells do something that they don't do?

      Wise.

      Comment


      • Originally posted by Leif View Post
        As SCI’ed and relatives one could choose to work for a SCI cure in different ways and arrays, sure… If a person or clinicians - and network admin wants to do it so or so, fine by me. But as said before, Wise has said this website should not become a promoting website for a particular advocating and promoting website – well; now in much comments by Dr. Young this place has become just that. A website for pressuring own opinions. Go to Italy Young J
        Leif, you need to see a doctor... I'll see if I can find one for you in Florence
        In God we trust; all others bring data. - Edwards Deming

        Comment


        • Originally posted by paolocipolla View Post
          Leif, you need to see a doctor... I'll see if I can find one for you in Florence
          Great idea!
          "It's not the despair, I can handle the despair! It's the hope!" - John Cleese

          Don't ask what clinical trials can do for you, ask what you can do for clinical trials. (Ox)
          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 Leif View Post
            As SCI’ed and relatives one could choose to work for a SCI cure in different ways and arrays, sure… If a person or clinicians - and network admin wants to do it so or so, fine by me. But as said before, Wise has said this website should not become a promoting website for a particular advocating and promoting website – well; now in much comments by Dr. Young this place has become just that. A website for pressuring own opinions. Go to Italy Young J
            Hi Leif,

            I think your miss reading the enthusiasum or promotion of scinetusa

            for me it's less about the therapy and more about the network

            yes i have hope in ubc+lithium and probably more in other combinations however i and you aren't making those decisions just second guessing them.

            if we have the network and the ubc fails we move on to another

            this in reality is not esc over ubc because in the discusion i saw about the chinascinet the second choice was bone marrow cells or some thing like that

            esc was not mentioned and not because of moral concerns but because of science, practicality and readiness

            this was in 05 so maybe things have changed
            http://justadollarplease.org/

            2010 SCINet Clinical Trial Support Squad Member

            "You kids and your cures, why back when I was injured they gave us a wheelchair and that's the way it was and we liked it!" Grumpy Old Man

            .."i used to be able to goof around so much because i knew Superman had my back. now all i've got is his example -- and that's gonna have to be enough."

            Comment


            • Originally posted by Leif View Post
              As SCI’ed and relatives one could choose to work for a SCI cure in different ways and arrays, sure… If a person or clinicians - and network admin wants to do it so or so, fine by me. But as said before, Wise has said this website should not become a promoting website for a particular advocating and promoting website – well; now in much comments by Dr. Young this place has become just that. A website for pressuring own opinions. Go to Italy Young J
              Dear Leif,
              You are obviously very educated in SCI matters.
              I wish that all researches WORLDWIDE could come together pooling resources to improve function. It would be so fantastic if there was ONE Database they all had to log on to. Want a dollar for a petri dish then type it in. Socialized medicine maybe. Who really gives a shit who figures it out. My dream is that it is figured out.
              I want to know why USA'S FDA, approves weight loss pills that ruin bodies while SCI Research is so handicapped.

              Comment


              • The Academy of Spinal Cord Injury Professionals Advance SCI Care

                Spinal Cord injury and spinal cord dysfunction patients have new cause to celebrate. Last week marked the official launch of the Academy of SpinalCord Injury Professionals. With support form the Paralyzed Veterans of America, the new interdisciplinary academy aims at improving the quality of care and quality of life for spinalcord injury patients.
                Nurses, doctors, social workers, rehabilitation therapists, and psychologists will be able to work together more closely as part of the new academy to share data and pool their knowledge and experience to work toward developing more effective treatment plans and improving the quality of life-long care for those suffering with spinal cord injuries.
                The Academy of Spinal Cord Injury Professionals arose as a merger between the American Association of SpinalCord Injury Nurses, the American Paraplegia Society, the American Association of SpinalCord Injury Psychologists and Social Workers, and the Therapy Leadership Council in Spinal Cord Injury.
                The professionals who make up the academy hope to achieve their goals by way of: raising public, lawmaker, and charitable organization awareness of the challenges of life with spinal cord injury; encouraging community development in support of spinal cord injury patients; and providing advanced networking opportunities for spinal cord injury professionals.
                As in many areas of science, an interdisciplinary collaboration can result in revelations and rapid advances in applicable knowledge due to the sharing of experience and information facilitated by such partnerships. For example, a spinal cord injury psychologist may be able to assist as a liaison between patient and family and between patient and doctor, making communication and understanding more easily achieved for all parties involved.
                The Academy of Spinal Cord Injury Professionals uses “Many Minds, One Vision,” as their tagline. The vision statement on their site reads, “The Academy of Spinal Cord Injury Professionals aims to be the world’s premier, interdisciplinary organization dedicated to advancing the care of people with spinal cord injury/dysfunction. We have one vision: it is a world where people with disabilities are healthier, more independent, and more empowered through a comprehensive lifetime of care and full community participation to take on all the challenges that life presents.”
                Email thisAdd to del.icio.usDigg This!Share on FacebookStumble It! Tags: networking opportunities, SpinalCord Injury(SCI), spinalcord professionals, spinalcordresearch
                This entry was posted on Thursday, October 8th, 2009 at 5:38 pm and is filed under Latest Research, SpinalCord Injury(SCI). You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site

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                • Originally posted by Wise Young View Post
                  Leif, I am sorry that you feel this way and I disagree with you.

                  If you want to push for the cure in your way, all the more power to you. But, if all you want to do is denigrate the work of others, please refrain. What you are doing is wrong.

                  Take a look at the Cure Forum and tell me honestly whether you think that we have really pressured people and promoted the umbilical cord blood and lithium therapies. In fact, I have posted so little about the therapies here that people don't know very much about it.

                  In contrast, there are multiple threads here about everybody's therapies, from Steven Davies, to X-cells and Geeta Shroff's cells, whatever they are. Every therapy from blue food dye to making rats walk automatically on treadmills has been hyped and discussed here.

                  Where has umbilical cord blood cells and lithium been hyped on this site? Yes, it has been discussed but what hype are you talking about? Has there been any claim that the cells (at least from me) that the cells do something that they don't do?

                  Wise.
                  There are so many potential therapies holding promise that we should not denigrate any unless they are obvious shams. There are so many ways to get involved. Raise your voice with legislators, give what you can within your means. Giving in to negativity is not something I choose even when I don't personally agree with the approach. Someone else could be right.

                  Comment


                  • Originally posted by c473s View Post
                    There are so many potential therapies holding promise that we should not denigrate any unless they are obvious shams. There are so many ways to get involved. Raise your voice with legislators, give what you can within your means. Giving in to negativity is not something I choose even when I don't personally agree with the approach. Someone else could be right.
                    Great point c4.
                    Choose a therapy/researcher you believe in and do everything you can to support.
                    This will get things moving!

                    Comment


                    • Umbilical cord blood and lithium

                      It has come to my attention that some people may have concern that umbilical cord blood cell transplants and lithium cause neuropathic pain in people. This was one of our concerns as well because lithium is known to increase neurotrophin expression in spinal cord and neurotrophins may increase neuropathic pain. So, I thought that I would post here a description of the data regarding umbilical cord blood and lithium treatment, the clinical trials that we have proposed and are carrying out, and the rationale for both the choice and design of the clinical trials.

                      Many laboratories have reported beneficial effects of umbilical cord blood cells in animal models of spinal cord injury and some groups have transplanted umbilical cord blood cells into people with spinal cord injury. Likewise, several laboratories have given spinal-injured rats lithium and we have tested lithium in people with spinal cord injury. To my knowledge, none of these have reported an increase in neuropathic pain.
                      • Six independent laboratories have implanted umbilical cord blood mononuclear cells in the spinal cords of rats, reporting better behavioral recovery and histological changes in treated animals compared to controls. To my knowledge, none of these groups have reported an increased incidence of autophagia or other problems that could be interpreted as being due to neuropathic pain.
                      • One group has transplanted umbilical cord blood cells into the spinal cord of one patient (Inchon, Korea) and several groups (unpublished) have been transfusing umbilical cord blood mononuclear cells intravenously or intrathecally into hundreds of patients in China, Mexico, and India. To my knowledge, none of these groups have encountered a significant problem with neuropathic pain, or at least that I have heard. However, none of these groups are following their patients closely. Except for the one patient in Inchon where they used HLA-matched cells, none of the other groups are using HLA-matched cells or transplanting the cells into the spinal cord. So, the clinical evidence is equivocal to date.
                      • Two laboratories have reported the potential beneficial effects of lithium on injured spinal cords. Wu, et al at Hong Kong University found that it stimulates regeneration and neural stem cell growth and differentiation in the spinal cord. Recently, a group in Texas published in the Journal of Neuroscience that lithium improves recovery in rats after contusion injuries. At Rutgers, we (unpublished) found that lithium stimulates umbilical cord blood cells to proliferate and to produce neurotrophins in the spinal cord. Unfortunately, we could not test this further (see below). So, the data suggests that lithium alone may improve recovery and may enhance the effects of other therapies, including umbilical cord blood mononuclear cell transplants into the spinal cord.
                      • The combination of umbilical cord blood cells and lithium treatment cannot be adequately tested in animals because we don't have HLA-matched umbilical cord blood from rats. When we transplanted neonatal rat (heterografts) and human (xenografts) into the spinal cord of rats, we found that the cells were immune-rejected within 3 weeks. While cyclosporin will prevent immune-rejection, we found that cyclosporin also blocked the effects of lithium. Although we can test the treatment combination in Fisher 533, immune-deficient rats, and inbred mouse strains, we have not yet validated our spinal cord injury model in these strains yet and we are in the process of doing so now.


                      In short, there is credible evidence that umbilical cord blood cells and lithium are beneficial in animal models of spinal cord injury, that lithium alone may be beneficial, and lithium may well enhance the beneficial effects of umbilical cord blood cells. While increasing neurotrophin expression in the spinal cord may increase neuropathic pain, we have not yet seen lithium or umbilical cord blood cell transplants do this in any animal study. It is possible that umbilical cord blood and lithium may enhance neuropathic pain, this is what the clinical trials will tell us. Ruling out adverse effects, such as increased neuropathic pain, is one of the reasons why phase I and II clinical trials are done. We are proceeding very carefully with such trials. If we see that umbilical cord blood plus lithium increases neuropathic pain, this would of course be important to know and taken into consideration in our recommendations.

                      We have proposed the following clinical trials:
                      • Phase I Lithium trial. This is in 20 patients with chronic spinal cord injury to determine whether lithium is safe. We gave lithum to 20 patients for 6 weeks and looked for adverse events, including increase in neuropathic pain. We are very aware that many studies have reported the lithium increases neurotrophin levels in the brain (this is regarded to be one of the mechanisms by which lithium is beneficial in manic depression). None of the patients in the trial showed any increase in neuropathic pain. Although 7 subjects dropped out of the trial during the first two weeks of starting lithium, none of them had toxic levels of lithium, none had signs of organ or tissue damage, and none had any increase in neuropathic pain.
                      • Phase II Lithium versus placebo. This is in 40 patients to determine whether lithium changes motor and sensory function in people with chronic spinal cord injury. This is a double-blind randomized placebo-controlled trial. We had only one patient drop out of the study and this was because he expressed suicidial ideations and the doctors were uncomfortable with continuing the patient on this study. None of the patients had any significant adverse events associated with the lithium treatment. We will be unblinding this study in November.
                      • Phase II Escalating Dose UCBMC. The trial will compare five groups of patients. This is an escalating dose trial where we will start out by making four injections of 4 µliters of cells into the spinal cord, two injections above and two below the injury site at a 45 degree angle through the dorsal root entry zones, exposed by minilaminectomies. If we encounter no significant adverse effects (such as loss of neurological function above the injury site), we go to four injections of 8 µliters. If no adverse effects, we go to four injections of 16 µliters. The standard injection that they have been using in China is 35-50 µliters above and below the injury site and so we do not anticipate significant neurological losses. If we encounter any problems (including neuropathic pain) in the patients after the injections, we will go to cell dose that does not cause any loss of neurological function or pain. In the fourth group, we will give a bolus dose of methylprednisolone (30 mg/kg) at the time of transplant. If no adverse effects, we will proceed to the fifth group of four patients who will receive the highest safe dose of cells plus methylprednisolone plus a 6 week course of oral lithium. We will carry this study out in Hong Kong and Austin TX, i.e. in a total of 40 ASIA A patients. If the umbilical cord blood cells cause neuropathic pain in the patients or the cells plus lithium does so, we will know and not continue the study.
                      • Phase III. If the phase II trials do not show any complications and produce some improvement in function, we will proceed to two phase III trials where we will assess larger numbers of patients that have received the cell transplants with and without lithium.
                        1. ChinaSCINet Trial. In China, we are proposing to transplant UCBMC into 400 subjects and then randomize them to lithium or no lithium. The subjects will be stratified by ASIA classification. The trial may show that neither therapy has any beneficial effect on motor and sensory function. In that case, I think that we can recommend against umbilical cord blood transplants with or without lithium. The trial may show that both therapy improves motor and/or sensory function. In such a case, we need to see what the U.S. trial shows before recommending the therapy. The trial may show that UCBMC plus lithium is significantly better the UCMBC alone. In that case, we can recommend UCBMC plus lithium. The trial will tell us whether the severity of injury affects the response to treatment and also whether the closeness of HLA-matching affects the response to treatment (we are allowing HLA matching of 4:6, 5:6, and 6:6).
                        2. SCINetUSA Trial. In the United States, the trial will compare four treatment groups. The first group will receive placebo (as opposed to lithium) and a 6-week course of intensive locomotor rehabilitation. The second group will receive lithium and the same 6-week course of rehabilitation. The third group will receive UCMBC transplant plus a 6-week course of placebo and rehabilitation. The fourth group will receive UCMBC transplant plus a 6-week course of lithium and rehabilitation. At the end of a year, the trial will tell us whether UCBMC plus lithium is better than UCBMC alone, lithium alone, or no treatment except rehabilitation. There will be a total of 60 patients per treatment group. The trial is restricted only to those with ASIA A injuries and C5 through T10 injuries. The subjects will all have chronic spinal cord injury (>1 year and stable neurologically for 6 months).


                      To date, we have not seen any sign of increased neuropathic pain in patients that have been treated with lithium for 6 weeks. We should soon see whether umbilical cord blood mononuclear cells have any effect on motor and sensory function, as well as neuropathic pain (visual analog scale). By the way, we are also measuring spasticity (Modified Ashworth scale) and the spinal cord independence measures (SCIM). In my opinion, we won't know until this has been tested in human. While rat studies are very useful for helping us discover potential therapies and helping us design the clinical trials, I think that that the question of whether the treatments will increase neuropathic pain is best answered in humans. That is why we have phase I and II trials.

                      We have of course considered many other cells besides umbilical cord blood cells. These include cells from aborted fetuses and embryonic stem cells, and brain and bone marrow autografts. Several problems with fetal and embryonic stem cells, such as olfactory ensheathing glia, make them less desirable and impractical as candidates for our first clinical trials. We have discussed doing trials for and with Geron, Woo-Suk Huang, and other places in China that have sources of fetal cells for transplantation. We decided against using fetal or embryonic cells, at least for our first trial, for the following reasons:
                      1. Neither fetal nor embryonic cells were or are available in sufficient quantity for our clinical trials,
                      2. The quality of fetal and embryonic cells are uncertain.
                      3. We don't have the GMP (Good Manufacturing Practice) facilities to process the cells for use in each of our centers
                      4. The cells are not immune-compatible with recipients, at least until cloned and IPS cells are available and neither are available at the present.


                      We will be using HLA-matched umbilical cord blood cells in the trials. All the units will be at least 4:6 HLA match. We are hoping that about 10% of the cells will be 6:6 and 25% will be 5:6 HLA matched. The phase III trials (particularly in ChinaSCINet) will have enough subjects so that we can stratify by HLA-matching and perhaps be able to assess whether better HLA-matching is associated with better neurological outcomes. The cells will all come from Stemcyte, which is certified by NMDP and all the major organizations that regulate and monitor quality of umbilical cord blood cells. The cells will be processed under GMP conditions.

                      While brain and bone marrow are sources of stem cells and autografts are immune-compatible, we ruled them out as well because we don't have GMP facilities at each center to collect and process the cells. Without such centers, we would have to collect the cells from each patient, freeze them for shipping to a central GMP processing facility, isolate and process the cells, and then ship them back to the hospital. It turns out that this is not only expensive but practical methods for freezing the collected tissue for mailing and refreezing the cells after processing are not available. I also don't feel comfortable harvesting cells from a person's brain,

                      We chose umbilical cord blood cells for the following reasons. First, they appear to be well behaved when transplanted into the spinal cord. They don't migrate everywhere. Second, there is no gliosis around the cells, suggesting that the cells are accepted by astrocytes. Third, none of the groups that have transplanted human umbilical cord blood mononuclear cells or CD34+ cells have reported that the cells cause tumors, neuropathic pain, or other problems in rats. We have confirmed the above with our own studies.

                      It is possible that lithium plus umbilical cord blood mononuclear cells will cause neuropathic pain in rats. We have not been able to test this adequately in rats because human umbilical cord blood or rat mononuclear cells isolated from neonatal rat blood are invariably immune-rejected from the spinal cord within 3 weeks. While we can get long term survival of the cells in the spinal cord when we give daily high-dose cyclosporin (10 mg/kg), we find that the cyclosporin directly and completely blocks the effects of lithium in the animals. Please note that we will be using HLA-matched umbilical cord blood cells in clinical trials and therefore will not need to use cyclosporin immune-suppression. The proposed phase II trials should reveal any safety problems associated with lithium or umbilical cord blood cell therapy of spinal cord injury.

                      In conclusion, we chose to test umbilical cord blood mononuclear cells in our trial because they have been reported by multiple independent laboratories to be beneficial in animal models of spinal cord injury, can be HLA-matched so that they are immune-compatible and not rejected, are available under the highest safety standards, and does not cause tumors, neuropathic pain, or other safety problems. Umbilical cord blood cells are also being used to treat hundreds (perhaps thousands) of people with spinal cord injury around the world by clinics that are charging for the therapy and not collecting data to show that the treatment is effective. Finally, several groups recently discovered that lithium stimulates regeneration in animal spinal cords and we found that lithium stimulates umbilical cord blood mononuclear cells to secrete neurotrophins. Therefore, we have proposed a systematic series of clinical trials to asses the safety and efficacy of umbilical cord blood mononuclear cells and lithium therapy, alone and in combination.

                      Comment


                      • hello

                        dear young wise you'd seen in neurological recovery in the test phase 1 and 2 with lithium?

                        Comment


                        • Originally posted by fti View Post
                          hello

                          dear young wise you'd seen in neurological recovery in the test phase 1 and 2 with lithium?
                          The first trial was not a controlled trial but we did not see any significant recovery compared to pre-treatment levels. We have not yet unblinded the second study and so I do not know yet. Wise.

                          Comment


                          • What is the possible date of unblinding the second study? Curious minds want to know.

                            Comment


                            • Originally posted by momo3 View Post
                              What is the possible date of unblinding the second study? Curious minds want to know.
                              momo3, I think he said November.

                              Comment


                              • Stem Cell news

                                University of California San Diego- Drs have seen that chronic conditions in rats have shown to be improved thru their research. Date of announcement 10,28,2009.

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