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

Phase 1

Active, not recruiting

• Conditions: Ischemic Stroke
• Interventions: Biological: NCS-01

• Registration Number: NCT03915431
• Lead Sponsor: NC Medial Research Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-11
• Study First Posted: 2019-04-16
• Study Start: 2020-02-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-11
• Primary Completion: 2027-10
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham	NCS-01	sham procedure
NCS-01	NCS-01	human bone marrow derived cells

Primary Outcome Measures

Name	Time	Method
Number of participants with change in Electrocardiography (ECG)	multiple times for the duration of the study (baseline through Month 12)	ECG (standard digital 12-lead in singlicate)
Number of participants with change in clinical laboratory evaluations	multiple times for the duration of the study (baseline through Month 12)	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,
National Institutes of Health Stroke Scale (NIHSS)	1 hour, 3 hours, and 6 hours post infusion	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.
Number of participants with change in in physical examination	multiple times from baseline through Month 12	physical examination changes General appearance ,Head, eyes, ears, nose, and throat, Respiratory, Cardiovascular, Musculoskeletal, Abdomen, Neurologic, Extremities, Dermatologic, Lymphatic)
Number of participants with adverse events -Safety by Incidence of Treatment-Emergent Adverse Events	multiple times for the duration of the study (baseline through Month 12)	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" . Incidence and nature of adverse events; vital signs;

Secondary Outcome Measures

Name	Time	Method
Number of participants with change in Cytokine panel (IL-1, 6, 8, etc.)	multiple times for the duration of the study (baseline through Month 12)	blood test for proteins that modulate the inflammatory response
Number of participants with change in MRI	multiple times for the duration of the study (baseline through Month 12)	global white matter and grey matter volumetrics; cortical thinning on MRI
Number of participants with change in Barthel Index	multiple times for the duration of the study (baseline through Month 12)	Barthel Index is a 4 point scale of Activities of Daily Living
Number of participants with change in Modified Rankin Scale (mRS)	multiple times for the duration of the study (baseline through Month 12)	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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States