Abstract
ABSTRACT Objective Extracellular vesicles (EVs) derived from regenerative mesenchymal stem cells might safely treat traumatic brain injury (TBI). We evaluated the safety and efficacy of a human bone marrow derived mesenchymal stem cell EVs (hBM-MSC EV) investigational product (IP) in a patient with severe TBI. Design A single case study employing an IP with a strong safety profile in over 200 patients. Method The patient was dosed intravenously three times/week in the first week of six successive months. Functional Independence Measure (FIM) and Functional Assessment Measure (FAM) were performed to quantify effects. Safety monitoring was performed every week for nine months. Results No adverse events occurred. Within eight weeks FIM and FAM scores improved by 48–55% and were sustained for the entire 36 weeks. All specific outcome items assessed by FIM and FAM that were initially low showed sustained improvements ranging from 41% to 233%, with the greatest improvements seen in locomotion, mobility and cognitive function. Conclusion After moderate improvement with conventional therapy, the substantial improvement observed following introduction of the IP suggests that hBM-MSC EVs may offer a novel and safe means to improve TBI patient outcomes. Appropriate randomized, controlled clinical trials to conclusively evaluate this therapeutic option are indicated.
Published Version
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