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

NCT04631406 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: NR1-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

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

  0-12 months

• Fugl Meyer (FM) motor score

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

  0-12 months

Study Arms (1)

Neural Stem cells injected intracerebrally

EXPERIMENTAL

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

Biological: Neural Stem Cells

Interventions

Neural Stem Cells BIOLOGICAL

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

Neural Stem cells injected intracerebrally

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gary Steinberg, MD, PhD: lead
• California Institute for Regenerative Medicine (CIRM): collaborator

Study Sites (1)

Stanford Health Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Gary K Steinberg, MD, PhD

  Professor, Neurosurgery Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Former Chair, Department of Neurosurgery, School of Medicine

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: November 17, 2020
• Study Start: January 4, 2021
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2029
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)