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Geron Corporation Message Board

  • tazamatic2002 tazamatic2002 Feb 20, 2013 1:47 PM Flag

    OPC1 trial final data collection date


    Spinal Cord Injury

    Biological: GRNOPC1

    Phase 1

    Study Type:


    Study Design:

    Allocation: Non-Randomized
    Endpoint Classification: Safety Study
    Intervention Model: Single Group Assignment
    Masking: Open Label
    Primary Purpose: Treatment

    Official Title:

    A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury

    Resource links provided by NLM:

    MedlinePlus related topics: Spinal Cord Injuries
    U.S. FDA Resources

    Further study details as provided by Geron Corporation:

    Primary Outcome Measures: •Safety [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    The primary endpoint is safety, as measured by the frequency and severity of adverse events within 1 year (365 days) of GRNOPC1 injection that are related to GRNOPC1, the injection procedure used to administer GRNOPC1, and/or the concomitant immunosuppression administered.

    Secondary Outcome Measures: •Neurological function [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    The secondary endpoint is neurological function as measured by sensory scores and lower extremity motor scores on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations.

    Estimated Enrollment:


    Study Start Date:

    October 2010

    Estimated Study Completion Date:

    March 2013

    Estimated Primary Completion Date:

    March 2013 (Final data collection date for primary outcome measure)

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