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Spinal Cord Injury (SCI) refers to an injury to the spinal cord that is caused by direct trauma or secondary damage to the surrounding bone, tissue, or blood vessels. Classification of the extent of the injury is based on neurological responses, touch and pinprick sensations tested in each dermatome (an area of the skin supplied by a single spinal nerve), and strength of ten key muscles on each side of the body, including the hip flexion (L2), shoulder shrug (C4), elbow flexion (C5), wrist extension (C6), and elbow extension (C7). The four categories of SCI classification and their respective percent of the market are: Complete Tetraplegia (16%), Incomplete Tetraplegia (41%), Complete Paraplegia (22%), and Incomplete Paraplegia (21%)
NSI-566 to be tested in patients with chronic spinal cord injury
ROCKVILLE, Md., Jan. 14, 2013 /PRNewswire/ — Neuralstem, Inc. (NYSE MKT: CUR) announced that it received approval from the United States Food and Drug Administration (FDA) to commence a Phase I safety trial of its lead cell therapy candidate, NSI-566, in chronic spinal cord injury patients. This open-label, multi-site study, will enroll up to eight patients with thoracic spinal cord injuries (T2-T12), who have an American Spinal Injury Association (AIS) A level of impairment, between one and two years after injury. AIS A impairment refers to a patient with no motor or sensory function in the relevant segments at and below the injury, and is considered to be complete paralysis.