Overview
Evaluation of the safety and tolerability of escalating doses of NR1 administered intracerebrally at a single time-point post-injury to subjects with chronic ISS with or without cortical stroke.
Description
Evaluation of the safety and tolerability of escalating doses of NR1 administered intracerebrally at a single time-point post-injury to subjects with chronic ISS with or without cortical stroke. The study will be a dose escalation using up to 4 cohorts each at a single dose level, of intracerebral administration of NR1 cells. Secondary objectives are to evaluate clinical and radiologic responses as well as utility of efficacy measurement tools.
Eligibility
Inclusion Criteria:
- Age 18 - 75 years
- History of ischemic subcortical stroke in the middle cerebral artery and/or lenticulostriate artery 6 to 60 months from time of stroke
- Ability of subject to understand and provide written Informed Consent
- Willing to take tacrolimus (Prograf) 2 days before and for 2 months after transplant
Exclusion Criteria:
- Stroke lesion less than 1 cubic centimeter or greater than 100 cubic centimeters measured by MRI
- Index stroke is lacunar infarct less than 1 year old
- History or presence of any major neurological disease
- History of active cancer other than basal or squamous cell skin cancers
- History of seizures
- Pregnant or breast-feeding