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

February 20, 2024 updated by: Gary Steinberg, MD, PhD

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford Health Center
        • Contact:
        • Principal Investigator:
          • Gary Steinberg, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Biological: Neural Stem Cells
NR1 is a human embryonic stem cell (hESC) derived product for the treatment of chronic ischemic subcortical stroke

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0-12 months
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
0-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gary Steinberg, MD, PhD

Collaborators

California Institute for Regenerative Medicine (CIRM)

Investigators

  • Principal Investigator: Gary K Steinberg, MD, PhD, Professor, Neurosurgery Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

April 11, 2019

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 17, 2020

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NR1-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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