Neuralstem Inc. has patented technology which enables, for the first time, the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities. The company’s technology also has the ability to control the differentiation of these cells into mature, physiologically relevant human neurons and glia. The company is targeting major central nervous systems diseases such as Amyotrophic Lateral Sclerosis (ALS), better known as Lou Gehrig’s disease.
The company announced today that the US Food & Drug Administration (FDA) has approved its investigational new drug application to commence a Phase 1 trial to treat ALS or Lou Gehrig’s disease with its spinal cord stem cells. Neuralstem is the first company to commence a stem cell trial to treat ALS. The disease affects roughly 30,000 people in the United States, with about 7,000 new diagnoses per year.
The trial will study the safety of Neuralstem’s cells and the surgical procedures and devices required for multiple injections of Neuralstem’s cells directly into the grey matter of the spinal cord. The FDA’s approval represents a significant step toward delivering regenerative medicine directly to damaged neural cells in humans.
Neuralstem’s CEO and president, Richard Garr, stated, “The beginning of our clinical trial program is a major step toward achieving Neuralstem’s goal of treating ALS, 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.”