SanBio has announced the successful enrolment of the second dose cohort of patients in its Phase I/IIa clinical trial testing the safety and efficacy of a novel allogeneic stem cell therapy product, SB623, in patients suffering from chronic deficits resulting from previous stroke injuries.
The first 12 patients, of a planned total of 18, have been successfully administered SB623. The trial is being conducted at Stanford University, the University of Pittsburgh and Northwestern University, USA, No safety concerns have been attributed to the cell therapy product.
SB623 is derived from adult bone marrow and has previously been proven to be safe and efficacious in rodent models of chronic stroke.
According to the company, SB623 is being delivered to the damaged region of the brain of patients who have suffered an ischaemic stroke. Product safety is the primary focus of the study but various measurements of efficacy are also being tested.
“We are pleased with the safety findings of the study thus far,” said Ernest Yankee, SanBio’s executive vice president of Development. “We anticipate completing the enrolment of the third and final dose cohort early in the year and reporting the results shortly thereafter.”
SB623 is a proprietary cell therapy product consisting of cells derived from genetically engineered bone marrow stromal cells obtained from healthy adult donors. SB623 is administered adjacent to the area damaged by stroke and functions by producing proteins that aid the regenerative process.