The Food and Drug Administration has given Neuralstem the green light to begin phase I testing of human stem cells to treat spinal cord injury (SCI).

The trial will evaluate the safety and toxicity of stem cell transplantation for treating paralysis and related symptoms of SCI.

“In August, in the peer-reviewed journal Cell, compelling evidence was presented that the cells can ‘bridge the gap’ in a severed spinal cord model and return functionality,” said Dr. Karl Johe, Neuralstem’s chairman of the board and chief scientific officer. “This will be the first stem cell trial to attack the problem that way as well as the first to treat chronic spinal cord injury patients.”

Up to eight patients with SCI in the T2-T12 levels of the spinal cord will be enrolled. Injuries must be an American Spinal Injury Association A level of impairment, which means that the person lacks motor or sensory function in the relevant segments, and the participant must be between one and two years post injury.

In addition, the study will evaluate graft survival in the transplant site by MRI and the effectiveness of transient immunosuppression.

Researchers will evaluate whether the stem cell transplantation has a positive effect on SCI by analyzing motor and sensory index scores, bowel and bladder function, pain, evoked sensory and motor potentials, electromyogram and other scores.

Study participants will receive six injections in or around the injury site, post-surgery physical therapy and immunosuppressive therapy. The trial study period will end six months after surgery for each patient.

Read the Cell article abstract here.