The Food and Drug Administration has approved the next phase of a clinical trial of stem cell therapy for ALS patients being conducted by Eva Feldman, M.D., Ph.D., director of the A. Alfred Taubman Medical Research Institute.
In the trial’s first phase, Feldman and her collaborators injected stem cells into the lumbar area of spinal cords of 12 patients with amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease). There have been no adverse side effects related to the procedure.
Going forward, the FDA has approved administering the injections into the cervical region of patients’ spines.
“We have been very encouraged by the early transplantations,” said Eva Feldman, MD, PhD, Principal Investigator of the trial and an unpaid consultant to Neuralstem “Cervical injections are essential, because therapy in this region is key to helping patients with their breathing. The deterioration of these functions most dramatically affect the patients’ quality of life and ultimately their life expectancy.”
Dr. Feldman is the Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System.
The Phase I trial to assess the safety of Neuralstem’s spinal cord neural stem cells and intraspinal transplantation method in ALS patients has been underway since January 2010. The procedures are taking place at Emory University.
Data recently presented to the FDA on the first 12 patients showed that eight out of ten living subjects in the trial had lower extremity function scores that remained the same or improved after treatment. Two out of ten showed continued decline of lower extremity function.
The trial will now progress to cervical spine injections. The first three of these will receive unilateral injections in the cervical region of the spine. The next three will receive bilateral injections in the cervical region.
For additional information, see the Neuralstem press release.