On 20 March, SanBio announced the successful enrolment of the first dose cohort of patients in its phase 1/2a clinical trial testing the safety and efficacy of SB623, a novel allogeneic stem cell therapy product, in patients suffering from chronic deficits resulting from previous stroke injuries.
The first six patients, of a total of 18, have been successfully administered SB623. The trial is being conducted at Stanford University and the University of Pittsburgh. No safety concerns have been reported. Product safety is the primary focus of the study but various measurements of efficacy are also being tested.
SB623 is derived from adult bone marrow and has shown safety and efficacy in rodent models of chronic stroke. “This represents a major milestone in the human clinical testing of this important new approach for regenerative medicine”, said Keita Mori, CEO, SanBio. “We are pleased to learn that the initial dose level was well tolerated.”
The therapy is administered adjacent to the area damaged by stroke and functions by producing proteins that aid the regenerative process.