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

Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04631406
• Other study ID #: NR1-02
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 4, 2021
• Est. completion date: May 31, 2025

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: Clinical Research Coordinator
• Phone: 650-723-0508
• Email: stemcellstudy[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Biological:
• Neural Stem Cells
NR1 is a human embryonic stem cell (hESC) derived product for the treatment of chronic ischemic subcortical stroke

Locations

Country	Name	City	State
United States	Stanford Health Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Gary Steinberg, MD, PhD	California Institute for Regenerative Medicine (CIRM)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	0-12 months
Primary	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