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

Gary Steinberg, MD, PhD

Status and phase

Active, not recruiting

Phase 2

Phase 1

Conditions

Ischemic Stroke

Treatments

Biological: Neural Stem Cells

Study type

Interventional

Funder types

Other

Identifiers

NCT04631406

NR1-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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