Suspended

Intracerebral Transplantation of Neural Stem Cells for Chronic Ischemic Subcortical Stroke

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Study Aim

This study aims to evaluate the safety and effectiveness of intracerebral transplantation of neural stem cells as a treatment for chronic ischemic subcortical stroke, by observing changes in neurologic functional outcome and monitoring treatment-related adverse events.

What is being tested

Neural Stem Cells

Biological
Who is being recruted

Ischemic Stroke+5

+ Brain Diseases

+ Cardiovascular Diseases

From 18 to 75 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: January 2021
See protocol details

Summary

Principal SponsorGary Steinberg, MD, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 4, 2021

Actual date on which the first participant was enrolled.

This study focuses on treating individuals who have experienced a chronic ischemic subcortical stroke, with or without cortical stroke. The main goal is to assess the safety and tolerability of a treatment involving neural stem cells, specifically NR1 cells. These cells are administered directly into the brain at a single point in time after the injury. The importance of this study lies in its potential to improve stroke treatment and care, addressing the challenges associated with chronic ischemic subcortical strokes. Participants in this study receive escalating doses of NR1 cells, divided into four cohorts, each at a single dose level. The treatment's effectiveness is measured through changes in neurological function, specifically using the Fugl Meyer motor score, which is compared to the participant's baseline score. The study also monitors the number of participants who experience treatment-related adverse events, as assessed by the Common Terminology Criteria for Adverse Events version 4.0. This helps evaluate the safety and potential side effects of the treatment.

Official TitleA 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
NCT04631406
Principal SponsorGary Steinberg, MD, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Ischemic StrokeBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesVascular DiseasesStroke

Criteria

4 inclusion criteria required to participate
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
6 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive increasing doses of brain cells, called Neural Stem Cells, to treat chronic stroke. These cells are injected directly into the brain.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Stanford Health Center

Stanford, United StatesOpen Stanford Health Center in Google Maps
SuspendedOne Study Center