Shepherd Center Treats First Patient in Clinical Trial of Investigational Product in Newly Injured People with Spinal Cord Injury
Shepherd Center has treated the first patient in a Phase 1/2a clinical trial evaluating escalating doses of 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 facilities throughout the United States participating in the clinical trial sponsored by Asterias Biotherapeutics Inc., a Menlo Park, Calif., biotechnology company focused on regenerative medicine. The study will test three sequential escalating doses of AST-OPC1 administered at up to 20 million AST-OPC1 cells in 13 patients with sub-acute, C-5 to C-7, neurologically complete cervical SCI. Patients, including the one treated at Shepherd Center on June 3, 2015, will be followed by neurological exams and imaging methods to assess the safety and activity of the product.
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. Additional information on the Phase 1/2a study, including trial sites, can be found at www.clinicaltrials.gov, using Identifier NCT02302157.
More than 12,000 people sustain a spinal cord injury each year, but there are no FDA-approved therapeutics or devices that could potentially restore some function in individuals who have recently sustained a spinal cord injury.
“If AST-OPC1 could deliver even modest improvements in motor or sensory function, it would result in significant improvements in quality of life,” said Donald Peck Leslie, M.D., medical director at Shepherd Center and principal investigator for the hospital for this clinical trial.
Once researchers compile initial safety data from the first two groups of patients enrolled in this study, Asterias plans to seek concurrence from the U.S. Food and Drug Administration to increase the robustness of the proof of concept in the Phase 1/2a clinical trial by expanding enrollment from 13 patients to up to 40 patients.
“We believe this change will increase the statistical confidence of the safety and efficacy readouts, reduce the risks of the AST-OPC1 program and position the product for potential accelerated regulatory approvals,” said Ed Wirth, M.D., Ph.D., chief medical officer for Asterias. The company has received a Strategic Partnerships Award grant from the California Institute for Regenerative Medicine, which provides $14.3 million of non-dilutive funding for the Phase 1/2a clinical trial and other product development activities for AST-OPC1.
This Phase 1/2a clinical trial follows successful results from the completed Phase 1 trial of AST-OPC1. It showed that a low dose of two million AST-OPC1 cells was safe and well-tolerated in 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 trial.
“The commencement of dosing in this Phase 1/2a trial is a significant advancement of our AST-OPC1 development program in that this study is specifically designed to evaluate the product at the doses and in the population where it has the maximum potential to bring benefit to patients,” said Pedro Lichtinger, president and CEO of Asterias. “Individuals with SCI have severe disabilities that can significantly shorten projected lifespan, impact quality of life and result in lifetime costs of care of $3 million to $4 million. We are grateful for the interest of patients with SCI to participate in this program.”
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 neurological 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 740 inpatients, nearly 280 day program patients and more than 7,100 outpatients each year in more than 46,000 visits.