Neurosurgery Rehabilitation Medicine News Archive Featured in the Media JeffNEWS

A study of a protein applied to the spinal cord for totally paralyzed patients during surgery shows some promise for spinal cord injury patients with some regaining partial movement.

A one-year clinical study of Cethrin(R), performed by neurosurgeons at Thomas Jefferson University Hospital in Philadelphia and other medical centers in the United States and Canada, indicated positive interim results for the treatment of acute spinal cord injury (SCI). The study was designed to determine if the protein was safe and well tolerated by SCI patients.

In the trial, 31 percent of patients recovered some sensory and/or motor function below the level of their injury, going from a complete injury to an incomplete injury. In one case, a patient who participated in the study at Jefferson was able to regain movement in his previously paralyzed legs.

“It’s pretty exciting,” said neurosurgeon James Harrop, M.D., Assistant Professor of Neurosurgery, Jefferson Medical College, the study’s primary investigator at Jefferson.

Dr. Harrop cautioned, however, that this is not a “panacea” and requires further study to determine if the protein can restore function.

“But in a population that has seen no progress in the last decade in restoring spinal cord functions, this is a huge leap,” he said.

There are currently no effective therapies for spinal cord injury and the nearly 12,000 new patients each year in North America alone. Despite significant scientific breakthroughs, existing clinical interventions remain limited to reducing local inflammation of the spinal cord.

The twelve-month study evaluated 37 patients from nine centers who suffered a complete thoracic or cervical injury (i.e. having no sensory or motor function below the level of the spinal cord injury). Five of the participants were seen at Jefferson.

“A complete injury means no sensation or movement below the lesion, while an incomplete injury means the patient has some neurologic function, either sensation
or motor,” Dr. Harrop explained.  “This is important because if they have any sensation or movement the chances for recovery are much improved.”

Cethrin(R) is topically applied to the dural sac (the membranous sac that encases the spinal cord within the bony structure of the vertebral column) during decompression/stabilization surgery. Cethrin(R) is the first of a new class of protein that is specifically designed to penetrate cells and inhibit Rho, a signaling master switch whose activation triggers cell death and exacerbates spinal cord damage following injury.

The trial was not placebo controlled but has an efficacy component based on the American Spinal Injury Association's (ASIA) scale which is designed toassess sensory and motor function in patients.