A Safety and Tolerability Study of Neural Stem Cells (NR1) in Subjects With Chronic Ischemic Subcortical Stroke (ISS)
- Conditions
- Ischemic Stroke
- Registration Number
- NCT04631406
- Lead Sponsor
- Gary Steinberg, MD, PhD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Age 18 - 75 years<br><br> - History of ischemic subcortical stroke in the middle cerebral artery and/or<br> lenticulostriate artery 6 to 60 months from time of stroke<br><br> - Ability of subject to understand and provide written Informed Consent<br><br> - Willing to take tacrolimus (Prograf) 2 days before and for 2 months after transplant<br><br>Exclusion Criteria:<br><br> - Stroke lesion less than 1 cubic centimeter or greater than 100 cubic centimeters<br> measured by MRI<br><br> - Index stroke is lacunar infarct less than 1 year old<br><br> - History or presence of any major neurological disease<br><br> - History of active cancer other than basal or squamous cell skin cancers<br><br> - History of seizures<br><br> - Pregnant or breast-feeding
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events;Fugl Meyer (FM) motor score
- Secondary Outcome Measures
Name Time Method