Clinical Compliance: Neuralstem Files For Stem Cell Trial
August 26, 2010 (FinancialWire) (Go to http://www.financialwire.net/?s=ftrdnwswnd for all of today’s featured news.) — Neuralstem, Inc. (AMEX: CUR) said that it has filed an Investigational New Drug application with the United States Food and Drug Administration to begin a Phase I safety clinical trial for chronic spinal cord injury with its spinal cord stem cells.
According to Neuralstem, the multicenter Phase I safety trial will enroll a total of 16 long-term, or chronic, spinal cord injury patients, with an American Spinal Injury Association Grade A level of impairment, one-to-two years post-injury.
ASIA A refers to a patient with no motor or sensory function in the relevant segments and is considered to be complete paralysis.
Clinical studies with chronic SCI patients have demonstrated that, even several years after motor- and sensory-complete SCI, intensive and task-specific rehabilitation can improve motor function as measured by the ASIA Impairment Scale .
Neuralstem believes that, in chronic SCI, its HSSC transplants may promote reorganization of segmental circuitry over the long-term. In the cervical region of the spinal cord, this could, according to the company, result in improved breathing capacity and recovery of sensori-motor functions of the upper limbs.
Neuralstem said that segmental reorganization induced by, and utilizing graft-derived neurons, may also result in improved locomotion.
Maryland-based Neuralstem owns patented technology meant to enable the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia.
Neuralstem is in a Phase I safety clinical trial for Amyotrophic Lateral Sclerosis, often referred to as Lou Gehrig's disease. The company is also targeting major central nervous system diseases in addition to ALS, including traumatic spinal cord injury, ischemic spastic paraplegia, and Huntington's disease. The company has also submitted an IND application to the FDA for a Phase I safety trial in chronic spinal cord injury.
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