Title
A Study of NCS-01 in Patients With Acute Ischemic Stroke
A Phase 1/2 Randomized Study to Evaluate the Safety and Tolerability of Intracarotid Artery Administration of NCS-01 in Patients With Acute Ischemic Stroke
Phase
Phase 1/Phase 2Lead Sponsor
NC Medial Research IncStudy Type
InterventionalStatus
RecruitingIndication/Condition
Ischemic StrokeIntervention/Treatment
NCS-01Study Participants
16This is an initial Phase1/2 dose-finding, randomized, multi-center study to evaluate the safety and tolerability of NCS-01 in patients with acute ischemic stroke. All patients will be randomized within 48 hours of stroke onset. This study will be conducted in 2 stages.
single infusion
Inclusion Criteria: Males and females, age 18 to 85 years inclusive Clinical evidence of acute ischemic unilateral cerebral infarction - Evidence of neurologic deficits as defined by NIHSS 6 to 18 or NIHSS < 6 with Fugl-Meyer upper extremity subtotal 6 to 40 inclusive Women of child bearing potential who agrees to take acceptable birth control as described in the ICF Provide written informed consent before participation, either by patient or a legal representative Exclusion Criteria: Progressive neurologic deficit An inability to undergo an MRI scan Any malignancies within the last 5 years Previous organ transplantation Participation in another clinical trial with an investigational drug, device or biologic within the preceding 3 months Women of childbearing potential with a positive pregnancy test Already dependent in activities of daily living (Rankin scale 3 or more) before the present acute stroke Known hypersensitivity, allergy or intolerance to the similar biologic interventions Any other clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with study objectives judged by Investigator based on medical history, physical examination, laboratory tests and/or ECG
