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

NCT03915431 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: NCS-01-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (5)

• 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;

  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.

  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)

  multiple times from baseline through Month 12

• Number of participants with change in Electrocardiography (ECG)

  ECG (standard digital 12-lead in singlicate)

  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,

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

Secondary Outcomes (4)

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

  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.)

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

• Number of participants with change in MRI

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

• Number of participants with change in Barthel Index

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

Other Outcomes (1)

• Number of participants with change in Domain-specific Scales (Fugl-Meyer)

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

Study Arms (2)

NCS-01

EXPERIMENTAL

human bone marrow derived cells

Biological: NCS-01

sham

SHAM COMPARATOR

sham procedure

Biological: NCS-01

Interventions

NCS-01 BIOLOGICAL

single infusion

NCS-01; sham

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NC Medial Research Inc: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sean Savitz, md

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 16, 2019
• Study Start: February 27, 2020
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)