Clinical Outcomes after Surgical Resection of Lesions in Eloquent Cortex using Functional MRI

摘要: Introduction An open-label dose-escalation Phase I trial of a highly purified, expandable population of human central nervous system stem cells (HuCNS-SC) was conducted in subjects with advanced stage infantile and late-infantile neuronal ceroid lipofuscinoses (INCL and LINCL). This investigation is the first US FDA authorized use of human neural stem cells for clinical testing. Methods Six pediatric subjects underwent bilateral intracerebral and intraventricular transplantation of HuCNS-SC. The low-dose cohort received a target dose of 500 million cells, and high-dose cohort received a target dose of 1 billion cells, followed by 12 months of immunosuppression. Subjects were assessed both pre- and post-transplant with a comprehensive battery of tests and brain magnetic resonance (MR) imaging. Results HuCNS-SC …