A Study of NCS-01 in Patients With Acute Ischemic Stroke

NC Medial Research

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Ischemic Stroke

Treatments: Biological: NCS-01

Study type: Interventional

Funder types: Industry

Identifiers

NCT03915431

NCS-01-01

Details and patient eligibility

About

This 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups

NCS-01

Experimental group

Description:

human bone marrow derived cells

Treatment:

Biological: NCS-01

sham

Sham Comparator group

Description:

sham procedure

Treatment:

Biological: NCS-01