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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00616980 | Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia | PHASE1 | COMPLETED | 28 | — | — | Dec 1, 2007 | Aug 1, 2010 | Jul 25, 2011 | 12 | United States |
| Arm | Type | Description |
|---|---|---|
| Low Dose | ACTIVE_COMPARATOR | - |
| High Dose | ACTIVE_COMPARATOR | - |
| Saline | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| CD34-positive cells | BIOLOGICAL | - |
| Saline and 5% autologous plasma | BIOLOGICAL | - |
Inclusion Criteria: * 21-80 years of age * moderate or high-risk Critical Limb Ischemia (Rutherford Clinical Severity Score 4 or 5) * unsuitable for conventional revascularization Exclusion Criteria: * advanced CLI (Rutherford Clinical Severity Score 6) characterized by extensive tissue loss or g...