Neuralstem Inc. has patented technology which enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities. The company today announced that it has filed an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to begin a Phase I safety clinical trial for chronic spinal cord injury with its spinal cord stem cells.
This Phase I safety trial will enroll a total of 16 long-term spinal cord injury patients that have complete paralysis. The proposed trial is primarily designed to test the safety of both Neuralstem’s cells and the transplantation delivery method in chronic spinal cord injury patients.
Animals studies have shown that even complete, chronically-injured spinal cord can undergo some degree of recovery and reorganization. Transplantation of the company’s human spinal stem cells (HSSC) is meant to provide a neuron-rich substrate to the injured segment of a patient’s spinal cord to promote further repair, regeneration and reorganization. The goal is to harness this inherent plasticity and promote reorganization by combining stem cell transplantation with the modern concept of activity-guided rehabilitation.
Neuralstem believes that in chronic spinal cord injuries, its human spinal stem cell transplants may promote reorganization of segmental circuitry over the long term. In the cervial region of the spinal cord, this could result in improved breathing capacity and recovery of sensory motors functions of the upper limbs and possibly even result in improved locomotion.
For more information on Neuralstem, please visit its website at www.neuralstem.com.