Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01495364 | NBS10 (Also Known as AMR-001) Versus Placebo Post ST Segment Elevation Myocardial Infarction | PHASE2 | COMPLETED | 195 | — | — | Dec 1, 2011 | Apr 1, 2016 | Apr 28, 2016 | 58 | United States |
The primary endpoint includes the occurrence of AE's, SAE's and Major Adverse Cardiac Events (MACE) and the assessment of myocardial perfusion measured by quantitative gated SPECT MPI specifically looking at resting total severity score.
| Arm | Type | Description |
|---|---|---|
| NBS10 | EXPERIMENTAL | active treatment - CD34+ cells |
| placebo | PLACEBO_COMPARATOR | matching placebo |
| Name | Type | Description |
|---|---|---|
| NBS10 | BIOLOGICAL | dosage = 10 or more million CD34+ cells via intracoronary infusion |
| placebo | OTHER | matching placebo |
Inclusion Criteria: 1. Age 18 years or older. 2. Acute ST elevation myocardial infarction meeting ACC/AHA criteria, with symptoms of chest pain within 3 days of admission. Criteria include (ST elevation \> 1mm in limb leads or 2 mm in two or more precordial leads, and increased levels of troponin, ...