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

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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04631406

Enrollment

Registered

2020-11-17

Start date

2021-01-04

Completion date

2029-08-31

Last updated

2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

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.

Interventions

BIOLOGICALNeural Stem Cells

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Treatment-Emergent Adverse Events	0-12 months	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Fugl Meyer (FM) motor score	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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORGary K Steinberg, MD, PhD

Professor, Neurosurgery Department

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026