MOUNTAIN VIEW, Calif., June 16 /PRNewswire/ — SanBio Inc. (www.san-bio.com) announced today
that the United States Food and Drug Administration (FDA) has
approved the clinical testing of their SB623 regenerative medicine
product in patients suffering from disability caused by cerebral
stroke. SB623 is derived from bone marrow stromal cells (MSCs)
isolated from healthy adult donors.
This Phase 1/2a clinical trial will test the safety of SB623
when implanted in the damaged regions of the brains of stable
stroke patients. “We are pleased and proud to be given the
opportunity to move this therapeutic approach forward. This is the
only clinical trial currently open in the
United States testing the regenerative potential of cell
therapy in the brain,” said Kieta
Mori, co-CEO of SanBio. “This cell product has the potential
to change the lives of patients afflicted by stroke injury,” said
Dr.
Douglas Kondziolka, the Peter J. Jannetta Professor of
Neurological Surgery in the Department of Neurological Surgery,
Director, Center for Brain Function and Behavior at the University of Pittsburgh School of Medicine
and a Principal Investigator in the SB623 clinical trial. According
to the American Heart Association, stroke is the third leading
cause of death in the United
States and the leading c
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