ANN ARBOR, Michigan — University of Michigan neurologist Dr. Eva L. Feldman will be the principal investigator for the first human clinical trial of a stem cell treatment for ALS, the fatal neurodegenerative disease also known as Lou Gehrig’s disease.
On Friday, the U.S. Food and Drug Administrationapproved an Investigational New Drug application from Neuralstem Inc., a Rockville, Md., biotechnology company, to test the safety of treating patients with injections of the company’s patented neural stem cells at severeal sites along the spinal cord, according to the University of Michigan.
As director of the university’s ALS Clinic and its Program for Neurology Research & Discovery, Dr. Feldman worked with a team of neurologists and with Neuralstem to develop the protocol for delivering the stem cells into the spinal cord of patients.
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The Phase 1 trial to determine the safety of the treatment is expected to take place at Emory University in Atlanta, Ga., subject to approval by its Internal Review Board, the University of Michigan said.
 “We are very excited about this clinical trial,” said Feldman, the DeJong Professor of Neurology at the University of Michigan Medical School, in a written statement. “This is a major stride forward in what still could be a long road to a new and improved treatment for ALS.”
ALS affects about 30,000 Americans, the university said. It progressively destroys the neurons that control voluntary muscles, leaving affected people unable to move or speak. There are no known treatments for the disease that slow its progression.
“ALS is a terrible disease that ultimately kills by paralysis,” Feldman said. “In work with animals, these spinal cord stem cells both protected at-risk motor neurons and made connections to the neurons controlling muscles. We don’t want to raise expectations unduly, but we believe these stem cells could produce similar results in patients with ALS.”
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Neuralstem, a publicly traded company, it is the first company to start a stem cell trial to treat ALS. The FDA’s approval represents a significant step toward delivering regenerative medicine directly to damaged neural cells in humans, Neuralstem said. ALS affects roughly 30,000 people in the United States, with about 7,000 new diagnoses per year, it said.
