Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04631406

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Stanford Health Center

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neural Stem Cells

Biological

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

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: 0-12 months

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  2. Fugl Meyer (FM) motor score

    Time frame: 0-12 months

    Change in neurologic functional outcome to evaluate efficacy post-injection as defined by change in Fugl Meyer motor score in comparison to baseline

Sponsors and collaborators

Lead sponsor

Gary Steinberg, MD, PhD

Other

Collaborators

  • California Institute for Regenerative Medicine (CIRM)

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2029
First posted
Nov 17, 2020
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.