Neuralstem has received approval from the US Food and Drug Administration (FDA) to begin the first Phase I trials to treat amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, with spinal cord stem cells.
The trial will examine the safety of Neuralstem’s stem cell products and the surgery procedure required for multiple injections of Neuralstem’s cells directly into the grey matter of the spinal cord.
The FDA has approved the first stage of the trial, which consists of 12 patients who will receive five to ten stem cell injections in the lumbar area of the spinal cord.
Neuralstem CEO and president Richard Garr said that ALS is a fatal neurodegenerative disease for which currently there is no effective treatment or cure.
“While this trial aims to primarily establish safety and feasibility data in treating ALS patients, we also hope to be able to measure a slowing down of the ALS degenerative process,” Garr said.
ALS affects around 30,000 people in the US, with about 7,000 new diagnoses per year.