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Thread: Neuralstem Expands Phase 1 Safety Trial of NSI-566 Neural Stem Cells in Spinal Injury

  1. #1
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    Neuralstem Expands Phase 1 Safety Trial of NSI-566 Neural Stem Cells in Spinal Injury

    Just got an email this morning.

    http://investor.neuralstem.com/phoen...int&ID=2261533


    News Release


    Neuralstem Expands Phase 1 Safety Trial of NSI-566 Neural Stem Cells in Spinal Injury


    Investigating New Patient Cohort with Cervical Injury
    GERMANTOWN, Md., April 12, 2017 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell technology, announced that a new cohort of four patients will be added to its ongoing Phase 1 human clinical trial evaluating the safety and feasibility of using NSI-566 spinal cord-derived neural stem cells to repair chronic spinal cord injury (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). NSI-566 is Neuralstem?s lead stem cell therapy candidate.


    Under the amended protocol, updated on clinicaltrials.gov (NCT01772810), four qualifying patients with AIS-A complete, quadriplegic, cervical injuries involving C5-C7 cord will be added to the study. The injury must have occurred 1-2 years prior to the time of stem cell treatment, which is a one-time surgery involving six injections of NSI-566 into the affected area of the cord. The study has begun active recruitment of patients.


    About 250,000 Americans are living with cSCI, and approximately 11,000 new injuries are reported each year1. Roughly 52% of these individuals will be considered paraplegic and 47% will be considered quadriplegic1. cSCI is a permanent and disabling condition with few to no treatments. Its devastating effect can be measured from social, healthcare, and economic perspectives.


    "This expansion of the study to cervical injuries builds on the results demonstrating that the implantation of NSI-566 stem cells in the first four patients with AIS-A complete thoracic cSCI was safe and feasible with no serious adverse events," said Karl Johe, Ph.D., Chief Scientific Officer, Neuralstem. "There is a tremendous unmet need in the treatment of cSCI and we are privileged to have the experts at UCSD School of Medicine and the Sanford Stem Cell Clinical Center at UC San Diego Health conducting the research. We look forward to further evaluating NSI-566 neural stem cells in chronic complete cervical injuries."


    Long-term safety data from the first cohort of chronic complete thoracic injuries is currently being analyzed by the study team at UCSD School of Medicine.




    Kinda sucks that they are only looking for patients that are 1-2 years post injury! Nevertheless I'm glad they expanded the trail!
    Last edited by Sparky831; 04-12-2017 at 08:56 AM.

  2. #2
    Senior Member lunasicc42's Avatar
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    ya I got this e-mail too but the thing I can't stand about Neuralstem is that this phase 1 study lasts an extremely long time

    It's been so long without an update from them about their chronic Spinal cord injury program that I Honestly thought that they abandoned their Spinal cord injury program
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    Can't find any links to sign up... Also seems like they just want cervical, but I'm @19 months so I'm interested.
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    Senior Member Wills77's Avatar
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    Quote Originally Posted by Mize View Post
    Can't find any links to sign up... Also seems like they just want cervical, but I'm @19 months so I'm interested.
    Contact info is towards the bottom of this link
    https://clinicaltrials.gov/ct2/show/...+injury&rank=1
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    Senior Member lunasicc42's Avatar
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    this question applies to this thread and the clinicaltrials.gov website in general...when Reading a clinical trial page, what is the difference between "estimated study completion date" and "estimated primary completion date"? And which is more important to a patient like me following the progression of the trial?
    "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!!!! "


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  6. #6
    Quote Originally Posted by Mize View Post
    Can't find any links to sign up... Also seems like they just want cervical, but I'm @19 months so I'm interested.
    Detailed Description:This is a Phase I, open-label, single-site, safety study of human spinal cord-derived neural stem cell (HSSC) transplantation for the treatment of chronic spinal cord injury (SCI) defined as at least one year but no more than 2 years after traumatic SCI. A maximum of 8 subjects with chronic SCI with American Spinal Injury Association Impairment Scale (AIS) A who meet eligibility criteria will be enrolled. No control group will be included. All subjects will receive spinal cord injections of HSSC: Group A: 4 patients with T2-T12 cord injury. Group B: 4 patients with C5-C7 cord injury. Study duration will be for 6 months for each subject. Post study, all subjects will be followed for additional 54 months by bi-annual visits during which safety assessments will be conducted as specified in the protocol.

    Inclusion Criteria:

    • Lives within 500 miles of study center

      1. Have the ability to understand the requirements of the study, provide written informed consent, understand and provide written authorization for the use and disclosure of Protected Health Information (PHI) [per Health Insurance Portability and Accountability Act (HIPAA) Privacy Ruling] and comply with the study procedures
      2. Men and women 18-65 years old
      3. Women must have a negative serum pregnancy test and practice an acceptable method of contraception or be of non-childbearing potential (post-menopausal for at least 2 years or who have undergone hysterectomy or oophorectomy or surgical sterilization)
      4. At least 1 year but no more than 2 years from time of injury at the time of surgery
      5. SCI injury classified as AIS-A complete as confirmed by the PI and a Physical Medicine and Rehabilitation doctor or other SCI Medicine board certified physician based on a complete ISNC SCI examination
      6. Neurologic level of injury:

        1. Group A: injury within cord segments T2-T12;
        2. Group B: injury within cord segments C5-C7

      7. Confirmation of bone fusion by CT scan
      8. Agrees to the visit schedule as outlined in the informed consent
      9. All required vaccinations current at the time of enrollment: tetanus/diptheria (TDAP), herpes zoster/shingles (Zostavax?: within last 10 years and must be prior to surgery), pneumonia (Pneumovax?), seasonal/H1N1 flu vaccines (as appropriate for season). Any missing vaccination will be provided at the screening if consented by the otherwise eligible patient who will then be scheduled for surgery no less than 30 days post vaccination.



  7. #7
    Quote Originally Posted by lunasicc42 View Post
    ya I got this e-mail too but the thing I can't stand about Neuralstem is that this phase 1 study lasts an extremely long time

    It's been so long without an update from them about their chronic Spinal cord injury program that I Honestly thought that they abandoned their Spinal cord injury program
    Phase 1 safety: they're watching for tumor growth and adverse events on the preliminary people injected. If they don't find anything wrong, the FDA allows more people to be injected. It's a time consuming process but a necessary one to protect the volunteers from unforeseen harm.

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    I'm only off by about 1700 miles unless someone wants to buy me a place near San Diego.
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    Senior Member lunasicc42's Avatar
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    Quote Originally Posted by GRAMMY View Post
    Phase 1 safety: they're watching for tumor growth and adverse events on the preliminary people injected. If they don't find anything wrong, the FDA allows more people to be injected. It's a time consuming process but a necessary one to protect the volunteers from unforeseen harm.
    I know that I was just saying that their phase 1 safety trial is scheduled to last a really long time...unusually long compared to most of the other sci trials...kinda strange thats all

    GRAMMY, do you know what the difference is between "estimated study completion date" and "estimated primary completion date"?
    "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!!!! "


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  10. #10
    Quote Originally Posted by lunasicc42 View Post
    this question applies to this thread and the clinicaltrials.gov website in general...when Reading a clinical trial page, what is the difference between "estimated study completion date" and "estimated primary completion date"? And which is more important to a patient like me following the progression of the trial?
    Quote Originally Posted by lunasicc42 View Post
    GRAMMY, do you know what the difference is between "estimated study completion date" and "estimated primary completion date"?
    https://clinicaltrials.gov/ct2/about-studies/glossary

    The Primary Completion Date is defined as the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome [measure], whether the clinical trial concluded according to the pre-specified protocol or was terminated.

    The Study Completion Date is defined as the final date on which data was collected.

    The Primary Completion Date is based on the data collection for the Primary Outcome Measure.

    Both dates are determined by when data were collected, not the date data were analyzed, the date the study was published or the date the study closed with the IRB.

    The Primary Completion Date may or may not be the same as the Study Completion Date.

    For Applicable Clinical Trials, results must be entered 1 year after the Primary Completion Date.Required data includes results for the Primary Outcome Measure, participant flow (the number of participants who started, completed, and dropped out of each period of the study), baseline demographics and adverse event/serious adverse event data.

    It is possible that data for the Primary Outcome Measure is required to be entered before data collection for a Secondary Outcome Measure is complete.
    Last edited by GRAMMY; 04-13-2017 at 06:52 PM.

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