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Neuralstem jumps after surgery to repair spinal cord injuries shows positive results

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    Neuralstem jumps after surgery to repair spinal cord injuries shows positive results

    Neuralstem?s lead stem cell therapy NSI-566 is undergoing clinical trials
    A diagram showing the human body and new applications of stem cells
    New stem cell technology could potentially help 250,000 Americans living with cSCI, a disabling condition with few to no treatments
    Biopharmaceutical company Neuralstem Inc. (NASDAQ:CUR) surged in early trading on Tuesday after it disclosed that successful surgery was completed on patients with chronic spinal cord injuries using its stem cell therapy.

    Neuralstem surged 10% to US$1.83 in morning trading.

    The clinical stage biopharmaceutical company develops new treatments for serious nervous system diseases. Neuralstem?s lead stem-cell therapy candidate NSI-566 is now undergoing mid-stage clinical trial.

    ?This study involves complete injury patients with no motor or sensory function below injury. The first four paraplegic cases with thoracic injury went exceptionally well,? said Karl Johe, Chief Scientific Officer at Neuralstem Inc.

    ?We are excited to move forward with the next four quadriplegic cases with cervical injury,? he added.

    Testing stem cells to treat spinal cord injuries
    Neuralstem is conducting a human clinical trial evaluating the safety and feasibility of using NSI-566 spinal cord-derived neural stem cells to repair cSCI, a permanent and disabling condition with few to no treatments.

    The National Spinal Cord Injury Statistical Center estimates that 250,000 Americans are living with cSCI with approximately 11,000 new injuries reported every year. More than half these individuals will be considered paraplegic and 47% will be considered quadriplegic.

    The clinical trial is being conducted at the University of California, in San Diego, which is one of the world's leading public research universities.


    http://www.proactiveinvestors.com/co...ts-194655.html
    "I'm manic as hell-
    But I'm goin' strong-
    Left my meds on the sink again-
    My head will be racing by lunchtime"

    <----Scott Weiland---->

    #2
    GERMANTOWN, Md., April 10, 2018 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell technology, today announced that it completed the first surgery in the second, cervical injury cohort of a Phase 1 clinical trial in patients with chronic spinal cord injury (cSCI). NSI-566 is Neuralstem’s lead stem cell therapy candidate.

    “This study involves complete injury patients with no motor or sensory function below injury. The first four paraplegic cases with thoracic injury went exceptionally well. We are excited to move forward with the next four quadriplegic cases with cervical injury,” said Karl Johe, Ph.D., the Chief Scientific Officer of Neuralstem.

    Neuralstem is conducting a Phase 1 human clinical trial evaluating the safety and feasibility of using NSI-566 spinal cord-derived neural stem cells to repair cSCI. The clinical trial is being conducted at the University of California San Diego, Division of Neurosurgery. In April 2017, the clinical trial was expanded to include a new cohort of four qualifying patients with AIS-A complete, quadriplegic, cervical injuries involving C5-C7 of their spinal cord, after promising results were observed with the first cohort. The clinical trial is evaluating the safety and feasibility of using NSI-566 spinal cord-derived neural stem cells to repair cSCI. The amended protocol was approved by the U.S. Food and Drug Administration and the Institutional Review Board at the study site, University of California San Diego (UCSD) and can be found on clinicaltrials.gov (NCT01772810). The first surgery for the second cohort was completed on March 28.

    According to the National Spinal Cord Injury Statistical Center at UAB, as of 2015, about 250,000 Americans are living with cSCI, and approximately 11,000 new injuries are reported each year. Approximately, 52% of these individuals will be considered paraplegic and 47% will be considered quadriplegic. cSCI is a permanent and disabling condition with few to no treatments. Its devastating effect can be measured from social, healthcare, and economic perspectives.

    About Neuralstem
    Neuralstem is a clinical-stage biopharmaceutical company developing novel treatments for nervous system diseases of high unmet medical need. The Company has two lead development candidates:

    NSI-189, is a small molecule in clinical development for major depressive disorder and in preclinical development for Angelman syndrome, irradiation-induced cognitive impairment, Type 1 and Type 2 diabetes, and stroke.
    NSI-566 is a stem cell therapy being tested for treatment of paralysis in stroke, Amyotrophic Lateral Sclerosis (ALS) and chronic spinal cord injury (cSCI).
    Neuralstem’s diversified portfolio of product candidates is based on its proprietary neural stem cell technology.

    Cautionary Statement Regarding Forward Looking Information
    This news release contains “forward-looking statements” made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements relate to future, not past, events and may often be identified by words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek” or “will.” Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Specific risks and uncertainties that could cause our actual results to differ materially from those expressed in our forward-looking statements include risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem’s periodic reports, including the Annual Report on Form 10-K for the year ended December 31, 2017 filed with the Securities and Exchange Commission (SEC), and in other reports filed with the SEC. We do not assume any obligation to update any forward-looking statements.


    https://globenewswire.com/news-relea...rd-Injury.html
    "I'm manic as hell-
    But I'm goin' strong-
    Left my meds on the sink again-
    My head will be racing by lunchtime"

    <----Scott Weiland---->

    Comment


      #3
      Where can I read more about the para trial?

      Comment


        #4
        Originally posted by lurch View Post
        Where can I read more about the para trial?
        It should be published in the next couple of months.

        https://spinalcordresearchandadvocacy.wordpress.com/2018/05/01/alliance-for-regenerative-medicine-arm-neuralstem-presentation/


        April 17, 2018


        Last edited by GRAMMY; 2 May 2018, 1:13 AM.
        http://spinalcordresearchandadvocacy.wordpress.com/

        Comment


          #5
          Mrs Powell what is your expectation of this trial?

          Also I thought about it while watching the video. Has anyone with SCI ever gotten ALS? After their SCI injury. If so how did ALS bridge the spinal cord injury?

          Comment


            #6
            This is the first write-up I've seen that uses cSCI as a term. I think I like it. These folks aren't padding results by using acute injuries like Invivo.
            T3 complete since Sept 2015.

            Comment


              #7
              Originally posted by #LHB# View Post
              Mrs Powell what is your expectation of this trial?
              We'll have more facts when the paper comes out but the FDA is confident enough on safety to allow them to move up to cervical injuries. I had posted some article links when the "pre-trial primate" paper was published. I've put a couple of them below. One important take away that gets lost is Dr. Mark Tuszynski's comments. I've heard him numerous times explain that their lab is working to identify the best stem cell for regeneration. That would include each level of injury as the niche is different in all the levels. Will NS-566 work best in all of them or at least provide some regeneration in all? Would an embryonic cell work better? I do feel the ongoing cellular work and primate models being used by the Tuszynski/Lu team are critical to find the best cell for the level of injury at hand. I think the data coming out of that lab in the coming years will be important in steering human clinical trials to success. Regeneration is slow, but we want the amount of regeneration to be the best that it can be. This trial will have it's gains, but there's much more important information coming in the future from this lab. Stay tuned.

              https://www.the-scientist.com/?artic...l-Cord-Injury/
              https://medicalxpress.com/news/2018-...ll-grafts.html
              https://www.eurekalert.org/pub_relea...-ruh022618.php

              https://spinalcordresearchandadvocac...e-spinal-cord/

              Dr. Mark Tuszynski video at Alliance for Regenerative Rehabilitation: Spinal Cord Injury and Neural Stem Cells https://spinalcordresearchandadvocacy.wordpress.com/2016/11/29/spinal-cord-injury-and-neural-stem-cells-by-mark-h-tuszynski/
              Last edited by GRAMMY; 2 May 2018, 12:29 PM.
              http://spinalcordresearchandadvocacy.wordpress.com/

              Comment


                #8
                Does anyone else ever feel that the farther we (they) get, it reveals that we've got farther to go than we originally thought? I want to keep the faith in some kind of meaningful treatment, but each advancement shows how complex the problem is. And how far the goal is.

                Comment


                  #9
                  Originally posted by quadfather View Post
                  Does anyone else ever feel that the farther we (they) get, it reveals that we've got farther to go than we originally thought? I want to keep the faith in some kind of meaningful treatment, but each advancement shows how complex the problem is. And how far the goal is.
                  Totally agree, I need the first treatment to come to market (whatever it is) to keep my morale up for certain.

                  Comment


                    #10
                    Originally posted by quadfather View Post
                    Does anyone else ever feel that the farther we (they) get, it reveals that we've got farther to go than we originally thought? I want to keep the faith in some kind of meaningful treatment, but each advancement shows how complex the problem is. And how far the goal is.
                    ... or may be it's easier than originally thought and scientists are making it complex because they want each success to be confirmed again and again.. If success is confirmed, scientists will desperately seek for something that might eventually be wrong with the treatment and will suggest we wait for 20 years to be sure there will not be cancerous cells coming from the treatment..
                    In the meantime we are all getting worst every year from our injuries and dying from our condition with no help from scientists..

                    Comment


                      #11
                      Originally posted by George78 View Post
                      ... or may be it's easier than originally thought and scientists are making it complex because they want each success to be confirmed again and again.. If success is confirmed, scientists will desperately seek for something that might eventually be wrong with the treatment and will suggest we wait for 20 years to be sure there will not be cancerous cells coming from the treatment..
                      In the meantime we are all getting worst every year from our injuries and dying from our condition with no help from scientists..
                      The SCI lab replication funding ran out from the NIH many years ago here in the United States. There were several lab contracted to verify important findings, among them was Os Steward of UC Irvine and Iztach Fischer of Drexel. There were several others contracted in their area of expertise. There's not funding to run the same exact experiments again and again. Anyway, not from the NIH. Scientists cannot get published in a journal if they just offer duplicated data that was already published. There are lots of tests needing done on cells before injecting such things in humans. A few years back there were tumor growths formed in a SCI replication study done in the Steward lab. I'm not aware of how they do research, funding and publications in Spain however.
                      http://spinalcordresearchandadvocacy.wordpress.com/

                      Comment


                        #12
                        Originally posted by George78 View Post
                        ... or may be it's easier than originally thought and scientists are making it complex because they want each success to be confirmed again and again.. If success is confirmed, scientists will desperately seek for something that might eventually be wrong with the treatment and will suggest we wait for 20 years to be sure there will not be cancerous cells coming from the treatment..
                        In the meantime we are all getting worst every year from our injuries and dying from our condition with no help from scientists..
                        The problem is finding funding in a for-profit system (here in the US). It's nearly impossible to put together a return on investment model that makes investment in SCI research worthwhile. You can spend tens of millions to target a tiny market of individuals who are effectively broke. For investors there are better choices.
                        T3 complete since Sept 2015.

                        Comment


                          #13
                          Will soon have less of an impact on future generations.
                          Originally posted by Mize View Post
                          The problem is finding funding in a for-profit system (here in the US). It's nearly impossible to put together a return on investment model that makes investment in SCI research worthwhile. You can spend tens of millions to target a tiny market of individuals who are effectively broke. For investors there are better choices.
                          Exactly, and the countries with socialist healthcare programs are not going to pay for any exclusive and brand new spinal cord regenerative treatment? a cure for chronic SCI is simply out of the question especially for high quadriplegics. Maybe in 50 years when stem cells are broadly used for much more common ailments like eye sight, muscle tissue damage, etc ( huge market potential ). much more complex injuries like spinal cord injury and Trumatic brain injury may be able to reap some kind of benefit indirectly.

                          It?s likely that stem cells or even genetic based therapies will be available to increase penis size ( and other cosmetics) before they are available for serious chronic spinal injury. The only serious conditions I see receiving beneficial stem cell treatments within the future are heart conditions and maybe organ transplantation, as in regenerating organs as it would be such a common treatment. ( Laboratories have grown various different organs [ in miniature form, non-functional] from the heart to the brain in vitro using stem cells.)

                          Having said that there is various forms of potential for acute injuries in the near future… And honestly I take some solace in that, I am happy that at some point this abhorrent condition that can lead to a life of just… pathetic levels of dependency, Will soon have less of an impact on future generations.
                          Last edited by JamesMcM; 21 May 2018, 7:08 PM.

                          Comment


                            #14
                            Originally posted by GRAMMY View Post
                            The SCI lab replication funding ran out from the NIH many years ago here in the United States. There were several lab contracted to verify important findings, among them was Os Steward of UC Irvine and Iztach Fischer of Drexel. There were several others contracted in their area of expertise. There's not funding to run the same exact experiments again and again. Anyway, not from the NIH. Scientists cannot get published in a journal if they just offer duplicated data that was already published. There are lots of tests needing done on cells before injecting such things in humans. A few years back there were tumor growths formed in a SCI replication study done in the Steward lab. I'm not aware of how they do research, funding and publications in Spain however.
                            You know far more about SCI research than I, but I would think that repeating cell testing would be very important, although boring as hell. One might run a test 10 times and always get the same result, but after 1000 repetitions, see an aberration caused cell differences, testing mistakes, etc. which need to be discovered before large scale human trials. It would seem like either automating the testing or out sourcing it (possibly to other countries) might be possible ways of reducing costs.

                            Comment


                              #15
                              Originally posted by khmorgan View Post
                              You know far more about SCI research than I, but I would think that repeating cell testing would be very important, although boring as hell. One might run a test 10 times and always get the same result, but after 1000 repetitions, see an aberration caused cell differences, testing mistakes, etc. which need to be discovered before large scale human trials. It would seem like either automating the testing or out sourcing it (possibly to other countries) might be possible ways of reducing costs.
                              That would make sense or at least worth giving it a try. Replications are vital. We wouldn't want potentially harmful cells and academia probably isn't the best platform for taking responsibility for such work and looking for the funding necessary to perform. It's pretty much left to the biotech labs to develop the cells. Academia is often asked to further test the cells in the various disease or injury models. The NIH funding for SCI replications kept the field accurate for quite awhile. If any lab reported extraordinary results and lots of hype was building, the replications were contracted so we'd know if everything as accurate and as plausible as thought to be in taking cells to human trial. This kept lots of worthless, harmful or expensive time wasting human trials from happening. We want successful trials, not failed ones. I believe a lot has been learned over the last decade and reducing costs is critical in getting anything moving forward and onto the right track. It's been a lot more difficult than anyone had first imagined.
                              http://spinalcordresearchandadvocacy.wordpress.com/

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