Two clinical studies have given people with severe TBI their own bone marrow mononuclear cells by IV within 48 hours of the injury. A randomized, double-blind, sham-controlled trial in children with severe TBI (47 randomized) concluded that the infusion was safe and feasible.9 A phase 1/2 study in 25 adults with severe TBI found the IV infusion safe and logistically feasible.10
These studies used a related but different approach from ours. The cells were bone marrow mononuclear cells, isolated and given within 48 hours of a severe injury, and the studies looked at safety and feasibility. Our procedure uses bone marrow concentrate for adults living with lasting symptoms. Two reviews cover the clinical trials of stem cells in TBI5 and the research on mesenchymal stem cells in TBI.2
For how mesenchymal stromal cells are thought to act, see Brain & neurological conditions.