A national clinical trial is under way at the University of Michigan Health System, where the first two patients in Michigan have received experimental stem cell injections to their spinal cords to help combat amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease.
Researchers are now monitoring the volunteers to assess the safety and potential side effects of the injections, both administered by Dr. Parag Patil, a neurosurgeon and biomedical engineer at U-M.
Phase II of the trial, which has been approved by the U.S. Food and Drug Administration, is designed to treat up to 15 patients. It seeks to study any effect that injected stem cells might have on muscle-controlling nerve cells that die in ALS patients, eventually leaving them unable to walk, speak, and breathe.
Potential patients with ALS are currently being evaluated for participation in the trial.
“We’re going to be permitted to give more injections and more stem cells,” Eva L. Feldman, professor of neurology at U-M Medical School, said in a statement. “We’re very excited that we have been able to bring this important work to the University of Michigan.”
Feldman serves as the principal investigator for the trial and has led the analysis of results from the Phase I trial, which concluded in 2012 at Emory University.
Researchers expect Phase II to be completed by the end of the second quarter in 2014.