Below is a press release from Santa Clara Valley Medical Center (SCVMC), a site in the AST-OPC1 SCiSTAR Phase 1/2a clinical trial in complete cervical spinal cord injury, which is being sponsored by BioTime, Inc. (NYSE MKT: BTX) subsidiary Asterias Biotherapeutics (NYSE MKT: AST).
The clinical trial will test the safety of three varying doses of AST-OPC1, which are oligodendrocyte progenitors that have the capacity to differentiate into a variety of brain cells. The California Institute of Regenerative Medicine (CIRM) also released a blog post about the procedure conducted at SCVMC.
The SCiSTAR study being run by Asterias Biotherapeutics is funded in part by a $14.3 million grant from CIRM. Enjoy!
Landmark Stem Cell Clinical Trial Procedure Performed at Santa Clara Valley Medical Center
July 13, 2016; Santa Clara County, CA — Last week, physicians at Santa Clara Valley Medical Center (SCVMC), in partnership with Stanford Medicine, successfully completed a surgery injecting stem cells into the spinal cord of a patient who had recently suffered a severe spinal cord injury. The patient became one of a handful of people in the world who have undergone this procedure as part of this clinical trial.
Stem cells have the potential to regenerate new tissues and organs. For individuals who have sustained a spinal cord injury, researchers are investigating whether stem cells might be able to restore some level of neurological function by replacing damaged neural connections.
“This groundbreaking scientific trial conducted at SCVMC hopefully shows progress toward affecting paralysis through stem cell treatments, and eventually to improvements in function that can greatly impact people’s lives,” said Dr. Stephen McKenna, Chief of the Rehabilitation Trauma Center at SCVMC.
Asterias Biotherapeutics, Inc. a California a biotechnology company focused on the emerging field of regenerative medicine, recently announced that dosing has been completed in the first group of patients in the SCiSTAR study. In this ongoing current Phase 1/2a of the study, SCVMC and other clinical trial sites are testing escalating doses of AST-OPC1 (oligodendrocyte – the stem cell treatment used in this study) in five newly injured patients with sensory and motor complete cervical spinal cord injury (SCI). The company expects to report top-line six-month efficacy and safety results from this five patient cohort in January 2017.
“We understand how to manage the unique challenges of spinal cord injury, but we are not able to reverse paralysis,” said James Crew, M.D., Chair of Physical Medicine and Rehabilitation at SCVMC. “If this study delivers even a modest benefit in neurological recovery, it would result in meaningful improvements in quality of life.”
“This clinical trial is a significant step forward in our efforts to apply stem cell therapy to patients with disabling spinal cord injury,” said Gary Steinberg, MD, PhD, professor and chair of neurosurgery at the Stanford University School of Medicine and the chief surgeon for the procedure. “Thus far, the transplant surgery appears to be safe. If the patients in this innovative study show improved neurologic function, it would represent a major therapeutic breakthrough.”
To determine if you or someone you know meets the clinical trial’s eligibility criteria, please visit www.clinicaltrials.gov and search for “AST-OPC1” or “NCT02302157” for the most up-to-date inclusion and exclusion criteria.
All clinical trial participants must be patients who are admitted to Santa Clara Valley Medical Center. Professionals are invited to refer patients for assessment to determine whether they are appropriate for admission.
About Santa Clara Valley Medical Center
Santa Clara Valley Medical Center is a comprehensive acute care public hospital system and Level 1 Trauma Center located in San Jose, California, the heart of Silicon Valley. SCVMC also offers a wide-range of specialty services and includes a large network of primary care clinics. Along with its nationally recognized and accredited Rehabilitation Center, Burn Center, Trauma Center, and other specialized programs and services, Santa Clara Valley Medical Center provides high quality and compassionate care to patients and their families. Please visit www.scvmc.org for more information.
About Stanford Medicine
A leader in the biomedical revolution, Stanford Medicine has a long tradition of leadership in pioneering research, creative teaching protocols and effective clinical therapies. Stanford Medicine includes the Stanford University School of Medicine, Stanford Health Care and Stanford Children’s Health. For information about all three, please visit http://med.stanford.edu.