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Thread: Stemedica Completes Pre-IND Meeting with the FDA for Ischemic Tolerant Neural Stem Ce

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    Stemedica Completes Pre-IND Meeting with the FDA for Ischemic Tolerant Neural Stem Ce

    Dr. Young, what do you think about this?



    Stemedica Completes Pre-IND Meeting with the FDA for Ischemic Tolerant Neural Stem Cells (itNSC)


    Stemedica announced that it completed its pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding a proposed IND (Investigational New Drug) application to evaluate the safety and efficacy of Stemedica's cGMP manufactured ischemic tolerant allogeneic neural stem cells (adult human) for spinal cord injury.
    San Diego, CA (PRWEB) January 24, 2012

    Stemedica Cell Technologies, Inc. (Stemedica), a world leader in stem cell research and manufacturing, announced that it completed its pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding a proposed IND (Investigational New Drug) application to evaluate the safety and efficacy of Stemedica's cGMP manufactured ischemic tolerant allogeneic neural stem cells (adult human) for spinal cord injury.

    The proposed initial clinical trial will be a Phase I/IIa for safety and dose escalation using ischemic tolerant adult allogeneic itNSCs administered via lumbar puncture to patients with spinal cord injury and paralysis. The proposed trial will take place at medical centers within the United States.

    read....

    http://www.prweb.com/releases/2012-s...web9133781.htm

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