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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2029-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ischemic Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neural Stem cells injected intracerebrally

Subject cohorts will be treated with increasing doses of Neural Stem Cells injected intracerebrally using a traditional 3+3 trial design

Group Type EXPERIMENTAL

Neural Stem Cells

Intervention Type BIOLOGICAL

NR1 is a human embryonic stem cell (hESC) derived product for the treatment of chronic ischemic subcortical stroke

Interventions

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Neural Stem Cells

NR1 is a human embryonic stem cell (hESC) derived product for the treatment of chronic ischemic subcortical stroke

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No