Second Phase of Patient Enrollment Begins in Clinical Trial of Investigational Treatment for Newly Injured People with Cervical Spinal Cord Injury
Shepherd Center is one of the clinical trial sites in the study funded by Asterias Biotherapeutics.
Asterias Biotherapeutics Inc., a Menlo Park, Calif., biotechnology company focused on the emerging field of regenerative medicine, has begun the second round of patient enrollment in a Phase 1/2a clinical trial of escalating doses of an investigational product to treat newly injured people with cervical spinal cord injury.
The first patient in the initial safety cohort was treated at Shepherd Center in early June. The second and third patients were successfully dosed at Chicago-based Rush University Medical Center. Asterias officials say the results of the clinical trial – called SCi-STAR – studying the investigational product, called AST-OPC1, continue to support a robust safety profile with no serious adverse events observed in any of the three treated patients to date. These patients received the initial low dose of 2 million cells, intended to test the safety of the injection procedure used to treat these patients.
The patient treated at Shepherd Center has completed a three-month post-injection assessment and has progressed from a complete ASIA Impairment Scale (AIS) A injury to an incomplete AIS C injury. The principal investigator at Shepherd Center, Medical Director Donald Peck Leslie, M.D., said, “This progress in the first patient is very encouraging and is observed in fewer than 5 percent of our AIS A patients at this stage of their recovery.”
The second cohort in this clinical trial will enroll five patients, who will receive 10 million AST-OPC1 cells.
“We are pleased with the confirmation of safety in the first dose cohort and we are excited to begin recruitment of patients who will receive 10 million AST-OPC1 cells," said Edward Wirth, M.D., Ph.D., chief medical officer of Asterias.
The open-label, single-arm study is being conducted at three medical facilities, including Shepherd Center, and will include up to 12 centers in the United States. The SCi-STAR trial 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 spinal cord injury. AST-OPC1 will be administered 14 to 30 days post-injury. Patients will be followed by neurological exams and imaging methods to assess the safety and activity of the product.
Additional information on the Phase 1/2a study, including trial sites, can be found at www.clinicaltrials.gov, using Identifier NCT02302157, and at the SCiStar study website (www.scistarstudy.com).
Upon achievement of initial safety data from the first two cohorts of 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. Asterias believes 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.
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.
All clinical trial participants at Shepherd Center must be patients who are admitted to Shepherd Center. Also, clinical trial eligibility requirements apply. Because time is of the essence with this investigational treatment, medical professionals are invited to promptly 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 provides world-class clinical care, research, and family support for people experiencing the most complex conditions, including spinal cord and brain injuries, multi-trauma, multiple amputations, stroke, multiple sclerosis, and pain. Ranked by U.S. News as one of the nation’s top 10 hospitals for rehabilitation and the best in the Southeast, Shepherd Center treats more than 850 inpatients and 7,600 outpatients annually with unmatched expertise and unwavering compassion to help them begin again.