Back to resultsA Safety and Tolerability Study of Neural Stem Cells (NR1) in Subjects With Chronic Ischemic Subcortical Stroke (ISS)
Primary Purpose
Ischemic Stroke
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Neural Stem Cells
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke
Eligibility 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
Sites / Locations
- Stanford Health CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neural Stem cells injected intracerebrally
Arm Description
Subject cohorts will be treated with increasing doses of Neural Stem Cells injected intracerebrally using a traditional 3+3 trial design
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04631406
First Posted
April 11, 2019
Last Updated
May 6, 2022
Sponsor
Gary Steinberg
Collaborators
California Institute for Regenerative Medicine (CIRM)
1. Study Identification
Unique Protocol Identification Number
NCT04631406
Brief Title
A Safety and Tolerability Study of Neural Stem Cells (NR1) in Subjects With Chronic Ischemic Subcortical Stroke (ISS)
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gary Steinberg
Collaborators
California Institute for Regenerative Medicine (CIRM)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neural Stem cells injected intracerebrally
Arm Type
Experimental
Arm Description
Subject cohorts will be treated with increasing doses of Neural Stem Cells injected intracerebrally using a traditional 3+3 trial design
Intervention Type
Biological
Intervention Name(s)
Neural Stem Cells
Intervention Description
NR1 is a human embryonic stem cell (hESC) derived product for the treatment of chronic ischemic subcortical stroke
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
0-12 months
Title
Fugl Meyer (FM) motor score
Description
Change in neurologic functional outcome to evaluate efficacy post-injection as defined by change in Fugl Meyer motor score in comparison to baseline
Time Frame
0-12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Research Coordinator
Phone
650-723-0508
Email
stemcellstudy@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary K Steinberg, MD, PhD
Organizational Affiliation
Professor, Neurosurgery Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Health Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Research Coordinator
Email
stemcellstudy@stanford.edu
First Name & Middle Initial & Last Name & Degree
Gary Steinberg, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Safety and Tolerability Study of Neural Stem Cells (NR1) in Subjects With Chronic Ischemic Subcortical Stroke (ISS)
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