A Safety and Tolerability Study of Neural Stem Cells (NR1) in Subjects with Chronic Ischemic Subcortical Stroke (ISS)
- Conditions
- Ischemic Stroke
- Interventions
- Biological: Neural Stem Cells
- Registration Number
- NCT04631406
- Lead Sponsor
- Gary Steinberg, MD, PhD
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Neural Stem cells injected intracerebrally Neural Stem Cells Subject cohorts will be treated with increasing doses of Neural Stem Cells injected intracerebrally using a traditional 3+3 trial design
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events 0-12 months Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Fugl Meyer (FM) motor score 0-12 months Change in neurologic functional outcome to evaluate efficacy post-injection as defined by change in Fugl Meyer motor score in comparison to baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Stanford Health Center
🇺🇸Stanford, California, United States
Stanford Health Center🇺🇸Stanford, California, United States