Application of DTI and Resting State fMRI in Clinical Trial of Neural Stem Cells (NR1) Intracerebral Transplantation for Chronic Ischemic Stroke

Motivation: Stem cell interventions demonstrated safety and efficacy in previous clinical trials; however, advanced neuroimaging methodology was rarely used to monitor the effect of functional recovery and outcome prediction. Goal(s): Investigate changes in neuroimaging measures following a Phase 1/2a unblinded, single-arm stem cell-based clinical trial in patients with chronic ischemic stroke. Approach: DTI and rs-fMRI processing pipelines were employed for data analysis to secure the reproducibility of the results. Results: Ipsi-lesional FICVF in the splenium of the corpus callosum significantly correlated with FMscore at 30days with increased connectivity in the contra-lesional sensorimotor area at 6months and 1year, suggesting recovery/adaptive processes in response to treatment. Impact: Monitoring neuroimaging changes may facilitate patient selection and predict both short- and long-term responses to cell therapy. Further data collection and molecular analysis are necessary to deepen our understanding of brain changes following stem cell therapy.