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

Phase 2Active Not RecruitingNCT04631406

Clarion Cells, Inc.27 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ischemic Stroke

Interventions

Neural Stem CellsBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford Health Center

Stanford, California, United States

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time frame: 0-12 months

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

Time frame: 0-12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.