A Safety and Tolerability Study of Neural Stem Cells (NR1) in Subjects With Chronic Ischemic Subcortical Stroke (ISS)

A Phase 1/Phase 2a Safety and Tolerability Study of Intracerebral Transplantation of Neural Stem Cells (NR1) in Subjects With Chronic Ischemic Subcortical Stroke (ISS) and Early Evaluation of Potentially Useful Efficacy Parameters

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.

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.

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