Neuralstem, Inc. CUR announced that it has received approval from the Food and Drug
Administration (FDA) to commence a Phase II trial using NSI-566 spinal
cord-derived human neural stem cells in the treatment of amyotrophic lateral
sclerosis (ALS or Lou Gehrig's disease). This Phase II dose escalation and
safety trial will expand to two centers, Emory University Hospital in Atlanta,
Georgia, where Phase I was recently completed, and ALS Clinic at the
University of Michigan Health System, in Ann Arbor, Michigan, subject to
approval by the Institutional Review Board at each institution. The trial is
designed to treat up to 15 patients, in five different dosing cohorts. All of
the patients will be ambulatory and reside within close geographic proximity
to the research center where they will participate. The first 12 patients will
receive injections in the cervical region of the spinal cord only, where the
stem cells could help preserve breathing function. The final three patients
will receive both cervical and lumbar injections.
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