Wednesday, August 25, 2010

Neuralstem Files FDA Application for First Chronic Spinal Cord Injury Stem Cell Trial

Source: Neuralstem, Inc.
Date: August 25, 2010

Summary:

In an official company news release, Neuralstem, Inc., a biotechnology company in the field of stem cell research, announced that it filed an application with the Food & Drug Administration to begin a clinical trial to attempt to treat chronic spinal cord injury using adult spinal cord stem cells:

Neuralstem, Inc. announced that it has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) to begin a Phase I safety clinical trial for chronic spinal cord injury with its spinal cord stem cells. This 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 (ASIA) 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.