At Emory University in Atlanta, Ga, the company Neuralstem, Inc, headquartered in Rockville, Md, recently announced its updated findings in a Phase I safety trial involving the use of spinal cord stem cells to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease and the approval for advancement by the Food and Drug Administration (FDA).
According to the company, the FDA has granted approval for Neuralstem’s trial to begin transplanting patients in the cervical back region. Up until this point, researchers say, patients have received injections in the lumbar region only.
Karl Johe, PhD, Neuralstem chairman and chief scientific officer, explains the goal of the cell therapy program, which is to, “Create therapies that will slow down, stabilize, or reverse, functional deficits in central nervous system (CNS) diseases. “By moving the cell delivery to the cervical spinal cord we will demonstrate that we can deliver our cells safely and routinely to all parts of the spinal cord.”
The trial was led by Eva Feldman, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at University of Michigan Health System, Jonathan D. Glass, MD, Director of the Emory ALS Center, and Emory neurosurgeon Nicholas M. Boilis, MD, who performed the trial’s surgeries.
The three doctors report that 12 ALS patients with unilateral or bilateral intraspinal injections of neural stem cells have been treated successfully. The patients tolerated the procedure, exhibited no major surgical complications and the doctors say there were no indications to date that the stem cells themselves are toxic or injurious to the spinal cord. “Our quantitative clinical assessments showed no evidence of acceleration of the disease following the stem cell injections, meeting our stated goal of proving safety for this Phase I trial,” the doctors add.
The first phase of this trial has been underway since January 2010. Its first 12 patients have been transplanted in the lumbar region and trial will now progress to the last six patients who will receive unilateral and bilateral injections in the cervical region of the back.