MOUNTAIN VIEW, Calif., Sept. 20, 2011 /PRNewswire/ -- SanBio, Inc., a leader in cell therapies for regenerative medicine, has announced the site initiation and opening of a Phase 1/2a clinical trial testing a novel cell therapy product, SB623, in patients suffering from disability resulting from ischemic stroke. The study is taking place at the University of Pittsburgh Medical Center. An additional study site is also open and recruiting patients at the Stanford University Medical Center in Palo Alto, CA.
SB623 has been shown to improve neurological behavior in preclinical models of stroke. In this study, safety and efficacy parameters will be evaluated, including improvements in motor function and cognitive status. The trial will evaluate 18 patients who have suffered an ischemic stroke within the past six to 24 months and have a motor neurological deficit.
"We are excited to be a part of this important new study offering a novel approach to therapy for patients suffering from ischemic stroke disability," said Douglas Kondziolka, MD, Peter J. Jannetta professor and vice chairman of neurological surgery at the University of Pittsburgh Medical Center (UPMC), and Principal Investigator of the study.
"Preclinical models have shown that SB623 restores function in animal models of stroke. With over seven million stroke victims in the U.S. today, we are eager to explore the potential of SB623 in patients who may otherwise be permanently disabled," said Lawrence Wechsler, MD, chair, department of neurology at UPMC.
"With two trial sites now open, our goal is to explore the potential of SB623 as a potential treatment for stroke disability as rapidly as possible," said Keita Mori, Co-CEO of SanBio. "SB623 represents a significant step forward in the development of regenerative therapies."
For more information on the SB623 trial, please visit www.strokeclinicaltrial.org.
SB623 is a proprietary regenerative cell therapy consisting of cells derived from genetically engineered bone marrow stromal cells obtained from healthy adult donors. SB623 functions by producing proteins that aid the healing process.
SanBio is a leader in the discovery and development of new regenerative cell therapy products. The company's first product, SB623, is currently in a Phase 1/2a clinical trial for stable stroke patients. In addition to SB623, SanBio is using its proprietary technology to develop programs in Parkinson's disease, spinal cord injury and traumatic brain injury. For more information, please visit san-bio.com.
SOURCE SanBio, Inc.