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FDA Approves SanBio’s Cerebral Stroke Clinical Trial

The US FDA has approved clinical testing of SanBio’s, SB623 regenerative medicine product in patients suffering from disability caused by cerebral stroke. SB623 is derived from bone marrow stromal cells isolated from healthy adult donors and genetically engineered. The trial will test the safety of SB623 when implanted in the damaged regions of the brains of stable stroke patients.

SanBio, Inc. develops regenerative therapies for neurological disorders. SanBio has used its proprietary technology to develop three products, SB623 for the treatment of stroke, spinal cord injury, and Parkinson’s disease, SB618 for the treatment of multiple sclerosis and spinal cord injury, and SB308 for the treatment of muscular dystrophy and trauma. Products have demonstrated the capability of reversing neural damage in a wide variety of disease models, with the lead product in the early clinical testing.

SanBio’s NDR technology uses genetic manipulation of bone marrow stromal cells that, when administered to damaged tissue, promote functional recovery. Bone marrow cells from a single donor can be used to treat thousands of patients. SanBio is also exploring the opportunity to deploy its technology to produce other types of cells to address unmet medical needs.