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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00872326 | Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia | PHASE1 | COMPLETED | 20 | — | — | Dec 1, 2007 | May 1, 2009 | Nov 14, 2014 | 1 | Spain |
| Arm | Type | Description |
|---|---|---|
| Autologous Bone Marrow Mononuclear Cells | EXPERIMENTAL | Consecutive inclusion among diabetic patients with critical limb ischemia. Intraarterial infusion of autologous bone marrow mononuclear cells |
| Name | Type | Description |
|---|---|---|
| Autologous Bone Marrow Mononuclear Cells | PROCEDURE | Infusion \> 80 millions mononuclear cells. Intraarterial administration at popliteal artery level. Infusion during 3 minutes with antegrade blockage of arterial flow. |
Inclusion Criteria: * Diabetic patients under treatment (type I or II) * Critical limb ischemia (rest pain and/or non-healing ischemic ulcers lasting more than 4 weeks, and/or Ankle-Brachial Index \< 0,8) * Not suitable to be revascularized (surgical and interventional consensus) Exclusion Criteri...