Stem Cell Study

Reprinted from PN/Paraplegia News April 2013

FDA approves study to determine safety and toxicity of human spinal stem cell transplantation.

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A study approved by the U.S. Food and Drug Administration (FDA) will determine the safety and toxicity of human spinal stem cell transplantation for treating paralysis and related symptoms due to chronic spinal-cord injury (SCI).

Neuralstem, Inc., has permission to begin a Phase I safety trial of its lead cell therapy candidate, NSI-566. This open-label, multisite study will enroll up to eight people with thoracic (T2–12) SCI who have an American Spinal Injury Association level of impairment (complete paralysis), between one and two years after injury.

Among the study’s secondary objectives are to evaluate graft survival in the transplant site by MRI, as well as the effectiveness of transient immunosuppression.

All patients in the study will receive six injections in or around the injury site. They also will have physical therapy post-surgery, as well as immunosuppressive therapy. The trial study period will end six months post-surgery for each person.

According to Karl Johe, PhD, Neuralstem chairman of the board and chief scientific officer, this will be the first stem-cell trial to treat chronic SCI patients.

In a September study published in the journal CELL (, paralyzed rats transplanted with NSI-566 stem cells recovered significant locomotor function, regaining movement in all lower-extremity joints. The transplanted neural stem cells turned into neurons that grew multiple axons.

In August 2012, Neuralstem completed dosing the last patient in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig’s disease. The company is also targeting major central nervous system conditions with its NSI-566 cell therapy platform, including SCI, ischemic stroke and glioblastoma (brain cancer).

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