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StemCells, Inc. Provides Update on Its Phase I/II Study in Spinal Cord Injury

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    StemCells, Inc. Provides Update on Its Phase I/II Study in Spinal Cord Injury

    Significant Sensory Gains Observed in Additional
    Patients


    NEWARK,
    Calif., May 19, 2014 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM)
    announced today that
    Armin Curt, M.D., study principal
    investigator, presented an interim update on the Phase I/II trial in spinal cord
    injury at the Annual Meeting of the American Spinal Injury
    Association in San
    Antonio, Texas. Interim analysis of clinical data to date has shown
    that the significant post-transplant gains in sensory function first reported in
    two patients have now been observed in two additional patients.

    http://investor.stemcellsinc.com/pho...2195&highlight=

    #2
    And there is a presentation included which illustrates the gains:

    http://www.stemcellsinc.com/Presenta...ASIA_FINAL.pdf

    Comment


      #3
      Originally posted by Proteus View Post
      And there is a presentation included which illustrates the gains:

      http://www.stemcellsinc.com/Presenta...ASIA_FINAL.pdf
      this is a great summary. excellent results, truly we are seeing the beginning.

      actual sensory gains!

      Comment


        #4
        I hope the can find a way to couple this with motor gains as well. Would have liked to see a higher percentage of folks getting returns perhaps the cell dosage may have been to low for them. Still exciting news
        Last edited by muskie; 20 May 2014, 10:32 AM.
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        Comment


          #5
          Originally posted by muskie View Post
          I hope the can find a way to couple this with motor gains as well. Would have liked to see a higher percentage of folks getting returns perhaps the cell dosage may have been to low for them. Still exciting news
          So would it be logical to next couple this type of therapy with locomotor training ?
          "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


            #6
            Locomotor with E-Stim?

            Comment


              #7
              maybe, I am far from an expert. I just see that there is positive results from a few different groups and to me maybe just maybe this is the beginning to get you folks and my son out of those damn chairs and reclaim what was stolen from you
              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


                #8
                Originally posted by muskie View Post
                maybe, I am far from an expert. I just see that there is positive results from a few different groups and to me maybe just maybe this is the beginning to get you folks and my son out of those damn chairs and reclaim what was stolen from you
                Thanks for the nice sentiment...fingers crossed
                "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


                  #9
                  Originally posted by muskie View Post
                  I hope the can find a way to couple this with motor gains as well. Would have liked to see a higher percentage of folks getting returns perhaps the cell dosage may have been to low for them. Still exciting news
                  I have red somwhere they are planning to double the dosage of cells in the next thoracic patients. That should show more recovery.

                  I wonder why they didn't include yet also ASIA C patients as it was planned. The animal studies showed motor recovery in rats with some mobility like ASIA C patients.

                  In any case I don't expect stem cells alone to provide much more recovery that this. They need to add something else like Chase, growth fators etc.. to see better results IMO. I know they know, but I don't know if they are working on it in the labs or if are just planning to team up with others working on complementary lines of reseach.

                  Paolo
                  In God we trust; all others bring data. - Edwards Deming

                  Comment


                    #10
                    Originally posted by paolocipolla View Post
                    I have red somwhere they are planning to double the dosage of cells in the next thoracic patients. That should show more recovery.

                    I wonder why they didn't include yet also ASIA C patients as it was planned. The animal studies showed motor recovery in rats with some mobility like ASIA C patients.

                    In any case I don't expect stem cells alone to provide much more recovery that this. They need to add something else like Chase, growth fators etc.. to see better results IMO. I know they know, but I don't know if they are working on it in the labs or if are just planning to team up with others working on complementary lines of reseach.

                    Paolo
                    One slow step at a time. I'm more interested in the Phase II results when they come out.
                    Last edited by Skipow; 21 May 2014, 4:27 PM.

                    Comment


                      #11
                      Yes - you have to take a controlled study approach to know what works and at what dosage level before combining therapies.

                      Comment


                        #12
                        The doses will increase in cell count in search of a theraputic number of cells (hopefully)

                        Comment


                          #13
                          StemCells, Inc. Posts Letter to Shareholders

                          NEWARK, Calif., May 29, 2014 (GLOBE NEWSWIRE) -- StemCells, Inc.(Nasdaq:STEM), a leading stem cell company developing novel cell-based therapeutics for disorders of the central nervous system, posted today the following Letter to Shareholders from its President and CEO,
                          Martin McGlynn.Dear Fellow Shareholders,

                          (...)

                          http://investor.stemcellsinc.com/pho...415&highlight=


                          "Much Ado About Nothing" or "Signs Of Things To Come"?
                          We recently completed enrollment in our Phase I/II spinal cord injury trial, which represents the world's first test of human neural stem cell transplantation in chronic injury. The interim data from this trial includes evidence of return of function to the spinal cord below the site of the injury. Due to the severity and location of the injuries in these cases, the types and degrees of sensory function gain that we have reported were not expected by experts. The fact that four of the eight patients dosed, to-date, have experienced return of sensation is, in and of itself, very encouraging, but we believe the fact that the regained sensation extends to as many as six segments below the level of injury is suggestive of a fundamental regenerative process occurring in the spinal cord.


                          Why are we so excited about these findings and why should you be, too?
                          The spinal cord can be compared to a building made up of many floors (i.e., segments) that are connected by elevators (i.e., conduits). Each floor, or segment, serves a specific purpose for control of both sensation and motor function. The lowest "floors," comprising the lumbar spine, control sensory and motor function to the legs and lower extremities; the middle "floors," or thoracic spine (the target for our first study), includes twelve individual segments that predominately serve sensation of the torso; above the thoracic, the cervical spine controls both sensory and motor function of the upper extremities. Restoring function to the cord after injury would connect the "floors," or segments of the spinal cord, and run the "elevators," which represent the conduits composed of long nerve fibers through which signals are transmitted back and forth from each floor to the top of the building — including the "penthouse" (i.e., the brain).
                          In our first study in spinal cord injury, we focused on the thoracic portion of the spine, the segments of which are represented by the middle floors of the building, which predominantly serve sensory function. Although spinal cord injury damages both the floors (segments) and the elevators (conduits), return of spinal cord function in the thoracic cord is likely to first manifest as recovery of sensation, the main purpose of the thoracic spine segments.
                          We are very encouraged by the multi-segmental gains and what it may mean for patients for which there is currently no other treatment option. Sensory function is a vital protective mechanism in our bodies, because it warns us about potentially harmful exposures or contacts. For example, being able to sense the temperature of the water in a shower or bath might prevent the spinal cord injury patient from getting third-degree burns. Secondly, injuries to the thoracic region tend to be more severe compared to injuries to the cervical region. Similar gains in function in the C3-C7 cervical region could potentially restore movement to the upper extremities, such that an SCI patient might be given use of the hands, arms and/or shoulders for the first time since the injury, and may significantly impact quality of life. We were very encouraged to see gains in spinal cord function following HuCNS-SC? transplantation up to 24 months post injury in some cases.
                          StemCells plans to initiate a controlled Phase II clinical trial this Fall, involving as many as a dozen clinical trial centers, to evaluate the efficacy of HuCNS-SC cells to restore movement, particularly to the upper limbs. We expect to complete enrollment in this study about one year later with final results following twelve months thereafter.

                          Comment


                            #14
                            StemCells, Inc. Initiates Phase II Clinical Trial in Cervical Spinal Cord Injury

                            First Study Assessing Efficacy of Neural Stem Cells for the Treatment
                            of Cervical Spinal Cord Injury

                            http://investor.stemcellsinc.com/pho...cle&ID=1974747


                            NEWARK, Calif., Oct. 7, 2014 (GLOBE NEWSWIRE) --

                            StemCells, Inc. (Nasdaq:STEM), a world leader in the research and development of cell
                            based therapies for the treatment of disorders of the central nervous system,
                            announced today that it has initiated its Pathway? Study, a Phase II
                            proof of concept clinical trial using its proprietary HuCNS-SC?
                            platform of human neural stem cells for the treatment of cervical spinal
                            cord injury (SCI).

                            (...)

                            The Pathway Study is the first clinical study designed to evaluate both the
                            safety and efficacy of transplanting stem cells into patients with traumatic
                            injury to the cervical spinal cord. The trial will be conducted as a randomized,
                            controlled, single-blind study and efficacy will be primarily measured by
                            assessing motor function according to the International Standards for
                            Neurological Classification of Spinal Cord Injury (ISNCSCI). The primary
                            efficacy outcome will focus on change in upper extremity strength as measured in
                            the hands, arms, and shoulders. The trial will follow the patients for one year
                            from the time of enrollment.

                            Earlier this year, the Company completed enrollment in an open-label Phase
                            I/II clinical trial in thoracic SCI and reported interim results from this trial
                            on eight patients with at least six months of follow-up post transplantation.
                            Half of the patients transplanted had significant post-transplant gains in
                            sensory function. The interim results also continue to confirm the favorable
                            safety profile of the cells and the surgical procedure. Based upon the strength
                            of the interim data from its thoracic SCI study, the Company made the decision
                            to move forward with the first in human clinical trial to assess the efficacy of
                            stem cell transplants for the treatment of cervical SCI.

                            "The initiation of the Pathway Study represents a major milestone for
                            StemCells, Inc. as we pursue the development of a truly breakthrough
                            therapy for spinal cord injury," said Martin McGlynn, president and chief
                            executive officer of StemCells, Inc. "While we are thrilled by the
                            prospect that patients with thoracic level injuries might be able to regain lost
                            sensory function below the site of the injury, the possibility that patients
                            with injuries to the cervical region of the cord might regain or improve lost
                            motor function could be truly life-changing."

                            The first site initiated into the Pathway Study is the University of
                            Miami Miller School of Medicine, home to The Miami Project To Cure
                            Paralysis, one of the world's most comprehensive research centers dedicated to
                            finding more effective treatments for, and ultimately a cure for, paralysis.

                            "Our center has been a leader in clinical research aimed at curing
                            paralysis," said Allan D. Levi, M.D., Ph.D., F.A.C.S., Robert M. Buck
                            Distinguished Chair in Neurological Surgery at the University of Miami
                            Miller School of Medicine and principle investigator for the center. "I
                            have been involved in pioneering research efforts in applying cellular
                            transplants to treat spinal cord injury patients for many years, and have
                            closely followed the pre-clinical and clinical efforts of StemCells. We are
                            excited to be the first site to open this important clinical trial. This is a
                            time of promise and hope for victims of spinal cord injuries and, should this
                            study be successful, it moves us one step closer to our ultimate goal of curing
                            paralysis."

                            About the Pathway Spinal Cord Injury Clinical Trial

                            The Company's Pathway Phase II clinical trial titled "Study of Human Central
                            Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury,"
                            will evaluate the safety and efficacy of transplanting the Company's proprietary
                            human neural system stem cells (HuCNS-SC cells) into patients with traumatic
                            injury in the cervical region of the spinal cord. This is a randomized,
                            controlled, single-blind study with a primary endpoint of change from baseline
                            in ISNCSCI upper extremity motor scores. Patients will be followed for a period
                            of twelve months post enrollment.

                            Information about the Company's spinal cord injury program can be found on
                            the StemCells, Inc. website at:

                            http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm

                            Information for patients interested in participating in the study is
                            available at the Pathway website at:

                            http://www.sciresearchstudy.com

                            Additional information about the clinical trial is available at:

                            http://clinicaltrials.gov/ct2/show/NCT02163876?term=stem+cells+cervical+spinal+cord+i njury&rank=1

                            About HuCNS-SC Cells

                            StemCells, Inc. has demonstrated human safety data from completed
                            and ongoing clinical studies of its proprietary HuCNS-SC cells. StemCells
                            clinicians and scientists believe that HuCNS-SC cells may have broad therapeutic
                            application for many diseases and disorders of the central nervous system (CNS).
                            Because the transplanted HuCNS-SC cells have been shown to engraft and survive
                            long-term, there is the possibility of a durable clinical effect following a
                            single transplantation. The Company's preclinical research has demonstrated that
                            HuCNS-SC cells can be directly transplanted in the CNS with no sign of tumor
                            formation or adverse effects. The HuCNS-SC platform technology is a highly
                            purified composition of human neural stem cells that are expanded and stored as
                            banks of cells.

                            Comment


                              #15
                              I believe there will be no shortage of volunteers for this trial. I have spoken to a clinical trial recipient that was in Switzerland for a T level injury he is about 8 months post now and has made sensory recovery and is working on the motor recovery. This is the best news I have heard in a while.
                              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

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