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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04631406
Recruitment Status : Recruiting
First Posted : November 17, 2020
Last Update Posted : May 10, 2022
Sponsor:
Collaborator:
California Institute for Regenerative Medicine (CIRM)
Information provided by (Responsible Party):
Gary Steinberg, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Biological: Neural Stem Cells Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : January 4, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04631406


Contacts
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Contact: Clinical Research Coordinator 650-723-0508 stemcellstudy@stanford.edu

Locations
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United States, California
Stanford Health Center Recruiting
Stanford, California, United States, 94305
Contact: Clinical Research Coordinator       stemcellstudy@stanford.edu   
Principal Investigator: Gary Steinberg, MD, PhD         
Sponsors and Collaborators
Gary Steinberg
California Institute for Regenerative Medicine (CIRM)
Investigators
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Principal Investigator: Gary K Steinberg, MD, PhD Professor, Neurosurgery Department
More Information
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Responsible Party: Gary Steinberg, Professor and Former Chair, Department of Neurosurgery, School of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT04631406    
Other Study ID Numbers: NR1-02
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes