Pharmaceutical Business review

Neuralstem files FDA application for ALS stem cell trial

The company is planning to treat amyotrophic lateral sclerosis (ALS) patients through spinal injections of its stem cells via its patented human neural stem cell technology.

ALS is a progressive neurodegenerative disease that affects nerve cells in the brain, leading to the degeneration and death of the motor neurons in the spinal cord that control the muscles. Loss of the ability to initiate and control muscle movement ends in paralysis and, ultimately, death.

Richard Garr, Neuralstem’s CEO and president, said: “Like all first human trials, this proposed trial is primarily designed to test the safety and feasibility of both our stem cells and our method of delivering the cells to the spinal cord in ALS patients. We are also proposing secondary endpoints which we hope will be able to measure a slowing down of the degenerative process.”