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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NCS-01 | Experimental | human bone marrow derived cells |
|
| sham | Sham Comparator | sham procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NCS-01 | Biological | single infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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, |
| Measure | Description | Time Frame |
|---|---|---|
| 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
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean Savitz, md | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| multiple times for the duration of the study (baseline through Month 12) |
| 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 | 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 | 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 | multiple times for the duration of the study (baseline through Month 12) |
| multiple times for the duration of the study (baseline through Month 12) |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |