Spinal surgeons at UC Davis Health System are enrolling individuals immediately following spinal cord injury in a multi-center clinical trial of an investigational compound that is being tested to determine whether it can protect and regenerate the spinal nerves after catastrophic injury.
To be considered for enrollment in the study, a participant must have suffered a spinal cord injury a maximum of 12 hours prior to the administration of the first dose of the investigational medication, and must be available for daily dosing for a total of 28 consecutive days.
The multi-centered clinical trial eventually will enroll a total of approximately 164 participants at acute-care medical centers throughout the United States. UC Davis is the only trauma center in Northern California participating in the clinical trial.
Acute spinal cord injury occurs in 13,000 to 15,000 individuals in the United States each year; well over half of the cases experience quadriplegia. The estimated lifetime cost of acute spinal cord injury for a 25-year-old patient is in the millions of dollars.
There currently is no drug treatment approved by regulatory agencies in the United States or European Union for treatment of patients with acute spinal cord injury. The current compound is called SUN13837and is being developed by Asubio Pharmaceuticals, Inc. of Paramas, New Jersey, as a treatment for spinal cord injury and stroke.
In the randomized, placebo-controlled clinical trial, individuals selected for participation will be assigned to receive either active treatment with the investigational medication or a placebo for a period of 28 days. Study subjects will be monitored throughout the study for adverse reactions to the drug and or procedures.
At UC Davis, the study is being led by Kee Kim, associate professor, co-director of the Spine Center and chief of spinal neurosurgery, and Eric Klineberg, assistant professor of orthopaedic surgery. Ripul Panchal, assistant professor of neurosurgery, Cassie Spalding-Dias, assistant professor of physical medicine and rehabilitation, and Daniel Nishijima, assistant professor of emergency medicine, also are collaborating on this clinical trial.
For further information, contact Caren Galloway, senior clinical research coordinator in the Department of Neurological Surgery, at 916-734-1727, firstname.lastname@example.org or Abhi Gorhe, senior clinical research coordinator in the Department of Orthopedic Surgery, at 916-734-3093, email@example.com.