Active — Not RecruitingPhase 1/2

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

United States30 participantsStarted 2021-01-04

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Incidence of Treatment-Emergent Adverse Events

Timeframe: 0-12 months

Fugl Meyer (FM) motor score

Timeframe: 0-12 months

Trial details

NCT IDNCT04631406

SponsorGary Steinberg, MD, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-31

View on ClinicalTrials.gov More Ischemic Stroke trials