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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01508910 | Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina | PHASE3 | COMPLETED | 291 | — | — | Apr 1, 2012 | Nov 1, 2015 | Dec 19, 2018 | 41 | United States |
Baseline (BL) is the average of the two total exercise times measured during the screening period.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm | EXPERIMENTAL | Targeted intramyocardial delivery of 1 x 10\^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis |
| Active Control Arm | PLACEBO_COMPARATOR | Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis |
| Unblinded Standard of Care (SOC) Arm | OTHER | No study-related procedures will be performed. |
| Name | Type | Description |
|---|---|---|
| Auto-CD34+ cells | BIOLOGICAL | 10 intramyocardial injections of 0.2 mL per injection site of Auto-CD34+ cells |
| Placebo: Diluent used to suspend Auto-CD34+ cells | BIOLOGICAL | 10 intramyocardial injections of 0.2 mL per injection site of placebo |
| Standard of care | OTHER | Standard of care for refractory angina |
Main Inclusion Criteria: * Male or female participants who are 21 to 80 years of age at the time of signing the informed consent. * Participants with Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina. * Participants without control of their angina symptoms in spite of ...