Neuralstem, Inc. has treated its first patient in phase II trial using NSI-566 spinal cord-derived neural stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) at Emory University Hospital in Atlanta, Georgia. The phase II dose escalation and safety trial, taking place at Emory and at the University of Michigan Health System, is designed to treat up to 15 patients in five different dosing cohorts.

All of the patients will be ambulatory and reside within the geographic region of the research center where they will participate. The first 12 patients will receive injections in the cervical region of the spinal cord only, where the stem cells could help preserve breathing function. The final three patients will receive both cervical and lumbar injections. The dose will also increase in both number of injections and cells per injection throughout the trial. In phase I, the trial progressed to a maximum of 15 injections of 100,000 cells each. In Phase II, the trial will advance up to a maximum of 40 injections and up to 400,000 cells per injection.

"The primary goal of our phase II trial is identify the maximum-safe tolerated dose," said Karl Johe, PhD, Neuralstem's chairman of the Board and chief scientific officer. "We also hope to transplant all of the patients in the trial by the completion of the second quarter of 2014. We are focused on cervical injections in this trial, which is the region of the spine that controls the breathing function, and where we believe we can have the strongest influence on the patients' quality of life and longevity."

Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia.