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

  1. #11
    Yes - you have to take a controlled study approach to know what works and at what dosage level before combining therapies.

  2. #12
    The doses will increase in cell count in search of a theraputic number of cells (hopefully)

  3. #13
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    [TD="bgcolor: transparent"]StemCells, Inc. Posts Letter to Shareholders[/TD]
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    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,

    (...)
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    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.

  4. #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.

  5. #15
    Senior Member muskie's Avatar
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    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.
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  6. #16
    Quote Originally Posted by muskie View Post
    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.
    What trial or what did he do?

  7. #17
    Senior Member lunasicc42's Avatar
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    Quote Originally Posted by muskie View Post
    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.

    Did that person say anything about bowel/bladder or sexual function ?

    Thanks
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  8. #18
    Senior Member muskie's Avatar
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  9. #19
    Quote 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
    More importantly hydrogels, to keep the cells safe and healthy through the injection process, and fixated at the injury site. This should be done with any stem cell treatment in humans.

  10. #20
    Senior Member muskie's Avatar
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    The following is a direct quote:

    I have made some gains in BBS mostly S which is a big deal for me also I am now an ASIA C we just confirmed that last week I have movement in my joints and can use abdominal and pelvis muscles below my injury I am a T2 and have good trunk stability to T11 and able to get little movement in my joints so now I have become a motor sensory incomplete which makes me a C. I'm back in Switzerland Oct 18th to the 24th I'm excited to see what will be charted after examinations.
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