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

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Trial ID: NCT04631406

Age - 18 Years-75 Years Condition - Stroke, Cerebrovascular Disease, Cerebrovascular Stroke Gender - All Accepting Healthy Volunteers - No

Purpose

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.

Official Title

A Phase 1/Phase 2a Safety and Tolerability Study of Intracerebral Transplantation of Neural Stem Cells (NR1) in Subjects With Chronic Ischemic Subcortical Stroke (ISS) and Early Evaluation of Potentially Useful Efficacy Parameters

Stanford Investigator(s)

Gary K. Steinberg, MD, PhD
Gary K. Steinberg, MD, PhD

Bernard and Ronni Lacroute-William Randolph Hearst Professor of Neurosurgery and Neurosciences and Professor, by courtesy, of Neurology

Eligibility


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

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Intervention(s):

biological: Neural Stem Cells

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Clinical Research Coordinator
650-723-0508

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