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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02501018 | Study to Assess the Efficacy and Safety of CLBS12 in Patients with Critical Limb Ischemia (CLI) | PHASE2 | COMPLETED | 33 | — | — | Nov 1, 2017 | May 19, 2022 | Oct 9, 2024 | 12 | Japan |
CLI-free is determined by assessing the Rutherford score (\</=3) by the investigator and a central adjudication committee.
| Arm | Type | Description |
|---|---|---|
| CLI Due to ASO with CLBS12 + SOC | EXPERIMENTAL | This group of subjects with CLI due to ASO will be administered with CLBS12 + SOC for collecting efficacy and safety data. |
| CLI Due to ASO with SOC | ACTIVE_COMPARATOR | This group of subjects with CLI due to ASO will be administered with SOC only. |
| CLI Due to BD with CLBS12 | EXPERIMENTAL | CLBS12 will be administered to patients with CLI due to BD for collecting safety and efficacy data. |
| Name | Type | Description |
|---|---|---|
| CLBS12 | BIOLOGICAL | Intramuscular transfusion of CLBS12. |
| SOC | DRUG | Standard of care (SOC) is defined as pharmacotherapy with approved drugs (e.g., antiplatelets, anticoagulants, and vasodilators including prostanoids). |
Inclusion Criteria: * subject has CLI caused by ASO or BD Exclusion Criteria: * \< 20 years old