Enrollment Opens for Clinical Trial Testing Investigational Product in Newly Injured People with Cervical Spinal Cord Injury
Patient enrollment in a Phase 1/2a clinical trial is now open at Shepherd Center to study an investigational product called AST-OPC1 (oligodendrocyte progenitor cells) in newly injured patients with sensory and motor-complete cervical spinal cord injury (SCI).
Shepherd Center is the first of up to eight rehabilitation centers throughout the United States that will enroll a total of 13 patients in the clinical trial sponsored by Asterias Biotherapeutics Inc., which is based in Menlo Park, Calif. No patients have been enrolled yet.
To meet the clinical trial’s eligibility criteria, patients must have:
- A sensory and motor complete, traumatic SCI (ASIA Impairment Scale A)
- Single neurological level of injury between cervical 5 and 7
- Ability to undergo surgery and AST-OPC1 injection between 14 and 30 days after injury
- Age between 18 and 65 at the time of injury
Other inclusion and exclusion criteria apply and may affect a patient’s ability to enroll in the clinical trial.
This clinical trial follows the successful completion of a Phase 1 trial of AST-OPC1 in which Asterias met its primary endpoints of safety and feasibility when the product was administered to five patients with neurologically complete, thoracic SCI. Shepherd Center was a site in the Phase 1 study and enrolled two of the five subjects in that study.
“The Phase 1 study generated a strong package of data regarding the safety of AST-OPC1,” said Donald Peck Leslie, M.D., medical director of Shepherd Center and principal investigator for this study site. “With the Phase 1/2a clinical trial, we are excited to begin testing AST-OPC1 at the doses and in the population where it has the maximum potential to bring benefit to patients.”
“There are currently no FDA-approved therapeutics or devices for the more than 12,000 individuals who sustain an SCI each year in the United States, or for the approximately 1.3 million Americans who are estimated to be living with an SCI,” said Richard G. Fessler, M.D., Ph.D., a professor of neurological surgery at Rush University Medical Center and principal investigator for the Phase 1 clinical trial. “If AST-OPC1 could deliver even modest improvements in motor or sensory function, it would result in significant improvements in quality of life for these patients."
The Phase 1/2a clinical trial is designed to assess safety and activity of three escalating doses of AST-OPC1. Patients will be followed by neurological exams and imaging methods to assess the safety and activity of the product.
All clinical trial participants must be patients who are admitted to Shepherd Center. Medical professionals are invited to refer patients for assessment to determine whether they are appropriate for admission to Shepherd Center. Contact Shepherd Center Admissions at 800-SHEPHERD (800-743-7437) or firstname.lastname@example.org.
For more information about Asterias, visit www.asteriasbiotherapeutics.com.
Shepherd Center, located in Atlanta, Georgia, is a private, not-for-profit hospital specializing in medical treatment, research and rehabilitation for people with spinal cord injury, brain injury, multiple sclerosis, spine and chronic pain, and other neuromuscular conditions. Founded in 1975, Shepherd Center is ranked by U.S. News & World Report among the top 10 rehabilitation hospitals in the nation. In its more than four decades, Shepherd Center has grown from a six-bed rehabilitation unit to a world-renowned, 152-bed hospital that treats more than 900 inpatients, 575 day program patients and more than 7,100 outpatients each year.