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

Trial ID or NCT#

NCT04631406

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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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Investigator(s)

Gary K. Steinberg, MD, PhD
Gary K. Steinberg, MD, PhD
Cerebrovascular neurosurgeon, Moyamoya surgeon, Aneurysm neurosurgeon, Neurosurgeon, Neurosurgeon
Bernard and Ronni Lacroute-William Randolph Hearst Professor of Neurosurgery and Neurosciences and Professor, by courtesy, of Neurology

Contact us to find out if this trial is right for you.

Contact

Clinical Research Coordinator
650-723-0508

View on ClinicalTrials.gov