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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01745744 | Application of Cell Regeneration Therapy With Mesenchymal Stem Cells From Adipose Tissue in Critical Chronic Ischemic Syndrome of Lower Limbs (CLI) in Nondiabetic Patients. | PHASE2 | COMPLETED | 33 | — | — | Feb 1, 2011 | Jul 1, 2018 | Jul 9, 2018 | 2 | Spain |
Number of adverse events and serious adverse events: 24h administration of CeTMAd, 1 month, 3 months, 6 months, 9 months and 12 months.
| Arm | Type | Description |
|---|---|---|
| Low dose | EXPERIMENTAL | \- Infusion of mesenchymal stem cells from adipose tissue: 0.5x106 cells / kg of patient weight. |
| High dose | EXPERIMENTAL | \- Infusion of mesenchymal stem cells from adipose tissue: 1x106 cells / kg of patient weight. |
| Control | NO_INTERVENTION | Conventional treatment |
| Name | Type | Description |
|---|---|---|
| Mesenchymal stem cells from adipose tissue | OTHER | \- Infusion of mesenchymal stem cells from adipose tissue administered intraarterially: 0.5x106 cells / kg of patient weight and 1x106 cells / kg of patient weight. |
Inclusion Criteria: * Patients of both sexes aged ≥ 18 and ≤ 89 years. * Nondiabetic. * Infrapopliteal atherosclerotic vascular disease of severe grade with either severe claudication or Rutherford-Becker grade II-III-IV, of at least one lower limb. It is defined critical ischemia of the lower limb...