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

Sex: All

Ages: 18 Years – 75 Years

Healthy volunteers: No

Phase: PHASE1, PHASE2

Enrollment: 27

Sponsor: Stanford University

Summary

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04631406). StuddyBuddy aggregates publicly available trial information.