Clinical trial NCT03915431: A Study of NCS-01 in Patients With Acute Ischemic Stroke
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Ischemic Stroke
Lead sponsor: NC Medial Research Inc
Sponsor class: INDUSTRY
First posted: 2019-04-16
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events -Safety by Incidence of Treatment-Emergent Adverse Events
timeFrame: multiple times for the duration of the study (baseline through Month 12)
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 1 hour, 3 hours, and 6 hours post infusion
measure: Number of participants with change in in physical examination
timeFrame: multiple times from baseline through Month 12
measure: Number of participants with change in Electrocardiography (ECG)
timeFrame: multiple times for the duration of the study (baseline through Month 12)
measure: Number of participants with change in clinical laboratory evaluations
timeFrame: multiple times for the duration of the study (baseline through Month 12)
Secondary outcomes:
measure: Number of participants with change in Modified Rankin Scale (mRS)
timeFrame: multiple times for the duration of the study (baseline through Month 12)
measure: Number of participants with change in Cytokine panel (IL-1, 6, 8, etc.)
timeFrame: multiple times for the duration of the study (baseline through Month 12)
measure: Number of participants with change in MRI
timeFrame: multiple times for the duration of the study (baseline through Month 12)
measure: Number of participants with change in Barthel Index
timeFrame: multiple times for the duration of the study (baseline through Month 12)
Other outcomes:
measure: Number of participants with change in Domain-specific Scales (Fugl-Meyer)
timeFrame: multiple times for the duration of the study (baseline through Month 12)
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sean Savitz, md
role: PRINCIPAL_INVESTIGATOR
References: