A Phase 1/2 interventional study of NCS-01 in Ischemic Stroke, sponsored by NC Medial Research Inc. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by NC Medial Research Inc · Phase 1/2, Interventional, and Treatment
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.
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's planned enrollment of 16 is below the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →This is the only study on the registry with NC Medial Research Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
human bone marrow derived cells
Biological: NCS-01
sham procedure
Biological: NCS-01
single infusion
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)
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)
Number of participants with change in Domain-specific Scales (Fugl-Meyer)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, sensation, balance, joint range of motion and joint pain in patients with post-stroke hemiplegia (Fugl-Meyer, Jaasko, Leyman, Olsson, \& Steglind, 1975; Gladstone, Danells, \& Black, 2002). It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.
Time frame: multiple times for the duration of the study (baseline through Month 12)
Plan to share: No
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This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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