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

Phase 2Active Not RecruitingNCT03915431

NC Medial Research Inc16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Ischemic Stroke

Interventions

NCS-01BIOLOGICAL

single infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

Number of participants with adverse events -Safety by Incidence of Treatment-Emergent Adverse Events

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" . Incidence and nature of adverse events; vital signs;

Time frame: multiple times for the duration of the study (baseline through Month 12)

National Institutes of Health Stroke Scale (NIHSS)

Change from baseline in the NIHSS NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The score for each ability is a number between 0 and 4, 0 being normal functioning and 4 being completely impaired. The patient's NIHSS score is calculated by adding the number for each element of the scale; 42 is the highest score possible. In the NIHSS, the higher the score, the more impaired a stroke patient is.

Time frame: 1 hour, 3 hours, and 6 hours post infusion

Number of participants with change in in physical examination

physical examination changes General appearance ,Head, eyes, ears, nose, and throat, Respiratory, Cardiovascular, Musculoskeletal, Abdomen, Neurologic, Extremities, Dermatologic, Lymphatic)

Time frame: multiple times from baseline through Month 12

Number of participants with change in Electrocardiography (ECG)

ECG (standard digital 12-lead in singlicate)

Time frame: multiple times for the duration of the study (baseline through Month 12)

Number of participants with change in clinical laboratory evaluations

changes in clinical laboratory evaluations (Creatinine, Potassium(K+),Sodium (Na+) , Chloride (Cl-), Magnesium (Mg++), Calcium, Inorganic phosphate, Glucose, Urea,Bilirubin (Total) ,Bilirubin (direct), AST, ALT, GGT, Alkaline phosphatase, Total Protein Albumin,

Time frame: multiple times for the duration of the study (baseline through Month 12)

Data from ClinicalTrials.gov

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Number of participants with change in Modified Rankin Scale (mRS)

The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke.Score Description 0 No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead

Time frame: multiple times for the duration of the study (baseline through Month 12)

Number of participants with change in Cytokine panel (IL-1, 6, 8, etc.)

blood test for proteins that modulate the inflammatory response

Time frame: multiple times for the duration of the study (baseline through Month 12)

Number of participants with change in MRI

global white matter and grey matter volumetrics; cortical thinning on MRI

Time frame: multiple times for the duration of the study (baseline through Month 12)

Number of participants with change in Barthel Index

Barthel Index is a 4 point scale of Activities of Daily Living

Time frame: multiple times for the duration of the study (baseline through Month 12)

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes