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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01211028 | Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine | PHASE1 | COMPLETED | 13 | — | — | Jan 1, 2009 | Jul 1, 2012 | May 11, 2017 | 1 | France |
To evaluate safety and tolerability related to the intramuscular injection of autologous adipose derived stroma/ stem cells. \[ Designated as safety issue: Yes \]
| Arm | Type | Description |
|---|---|---|
| Autologous ASCs | OTHER | Expanded autologous ASCs (Adipose Stroma/Stem Cells) Intramuscular dose of 100 million expanded cells. |
| Name | Type | Description |
|---|---|---|
| Expanded autologous ASCs | BIOLOGICAL | Drug: Expanded autologous adipose-derived adult stroma/stem cells |
Inclusion Criteria: * Severe peripheral vascular disease not amenable to bypass or angioplasty * Age \>40 years old * Normal renal function (creatinine \< 1.6) * Non pregnant female * Lifespan \> 6 months Exclusion Criteria: * Age \<40 years old * Refusal to give informed consent and/orCognitivel...