Stem Cells for Treating Acute Stroke

ABSTRACT SUMMARY In previous studies we identified novel non hematopoietic umbilical cord blood stem cellsnhUCBSCsthat could be expanded to high passages and exhibit restorative properties following ischemic brain injury repairWe found that the high passaged cells were equivalentif not even betterthan the low passaged nh UCBSCsThis finding suggests that these cells can serve as a source of highly expandable cells that can be manufactured under controlled conditions for potential therapeutic applicationsIn this Phase I II proposal we intend to scale up production of nh UCBSCs under good manufacturing practiceGMPconditions at the GMP facility located on the campus of the University of MinnesotaThese GMP manufactured cells will then be tested for efficacy using small animallaboratory ratand large animalnon human primatemodels of ischemic brain injuryIn consultation with the FDA we are proposing IND enabling studies to further qualifying these cells for use in a future clinical studyWe will evaluate the safety and potential tumorigenicity of these cellsevaluate mechanisms of action and effects of cryopreservationThe results from this study will provide key data required by the Food and Drug Administration for an IND to conduct a clinical trial on the use of these cells in the treatment of ischemic brain injury Narrative We have identified a highly expandable non hematopoietic stem cell population within human cord blood and evaluated its neuroprotective efficacy in laboratory rats with ischemic brain injuryThe goal of the present application is to scale up the production of these stem cells under good manufacturing practicesGMPand evaluate the effectiveness of these cells in treating ischemic brain injury in rats and non human primates to gather data needed to begin clinical trials