An international clinical trial sponsored by the company SanBio, Inc: A Study of Modified Stem Cells in Traumatic Brain Injury (TBI) (STEMTRA), ClinicalTrials.gov Identifier: NCT02416492. SUMMARY of the clinical trials.
This clinical trial is conducted on 26 Study Locations/ sites (??) in the USA, Japan, as well as in Ukraine at the Clinical Hospital “Feofaniya”; of the State Management of Affairs. The R&D Center provides delivery, cryostorage in liquid nitrogen vapors, thawing, washing, packaging, quality assessment (viability, sterility and endotoxin testing), and the delivery into a surgery of the clinic of the ready-to-use cell product SB623 (adult bone marrow-derived cells transiently transfected with a plasmid construct encoding the intracellular domain of human Notch-1).