Publications | October 2024
Abstract: Introduction: Secondary injury from traumatic brain injury (TBI) is an inflammatory process, peaking 72-96 hours after trauma and manifesting as acute inflammatory cytokine release, inflammatory cell infiltration, and blood-brain barrier dysfunction. This causes loss of gray and white matter and chronic microglial activation. Increased microglial activation causes worse functional outcomes. Studies have shown mesenchymal stromal cell (MSC) infusion dampens microglial activation and improves TBI outcomes. This study’s objective was to assess the impact of autologous adipose-derived MSC infusion in patients with chronic TBI using advanced imaging, functional, and neurocognitive outcomes measures.
Methods: This was a Phase 1 study analyzing the safety and efficacy of HB-adMSC infusion with a single-arm design. 24 patients with chronic TBI were enrolled. Outcomes measures included neuropsychological testing, neurocognitive testing, and multimodal MRI acquisition.
Results: Baseline Glasgow Outcome Scale-Extended (GOS-E) score was split evenly between severe (score 3-4) and moderate (5-6). GOS-E score improved at 6 months and 12 months, with more patients functioning as moderate (55%, 65%) than severe (45%, 35%). Odds of a good outcome increased over time, with the greatest improvement 12 months after treatment (odds ratio [OR] 1.71; 0.36). Patients reported improved cognitive function (p = 0.00017), communication (p = 0.0069), independence (p = 0.00076), and satisfaction with social roles and activities (p = 0.017) 12 months after infusion. 11CER176 PET-MRI analyses demonstrated reduction in depression, fatigue, and pain (p = 0.026, p = 0.008, p = 0.007) 6 months after infusion (Figure 1).
Conclusion: This demonstrates autologous adipose-derived MSC for chronic TBI is safe, has clinically relevant treatment effect sizes in functional and neurocognitive outcomes measures, and reduces microglial activation in regions corresponding to pain, fatigue, and depression.
Published: October 16, 2024
Publication: Journal of the American College of Surgeons (JAC) High-Impact Clinical Trials and Studies
CLI Author: Linda Ewing-Cobbs, PhD
Citation: High-Impact Clinical Trials and Studies. Journal of the American College of Surgeons 239(5):p S18-S20, November 2024. DOI: 10.1097/XCS.0000000000001206