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| Name | Class |
|---|---|
| French Blood Establishment | OTHER |
| Clinical Research Center, Toulouse | OTHER |
| Centre National de la Recherche Scientifique, France | OTHER |
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The main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with expanded adipose derived stroma/stem cells sue, administered intramuscularly in patients with critical leg ischemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous ASCs | Other | Expanded autologous ASCs (Adipose Stroma/Stem Cells) Intramuscular dose of 100 million expanded cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expanded autologous ASCs | Biological | Drug: Expanded autologous adipose-derived adult stroma/stem cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and Nature of Adverse Events : safety and tolerability | To evaluate safety and tolerability related to the intramuscular injection of autologous adipose derived stroma/ stem cells. [ Designated as safety issue: Yes ] | 15 days, 1, 2, 3, 4,5, 6 months for adverse events record |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandra BURA-RIVIERE, Pr | University Hospital of Toulouse, Rangueil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Toulouse, Rangueil | Toulouse | 31059 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14734516 | Background | Planat-Benard V, Silvestre JS, Cousin B, Andre M, Nibbelink M, Tamarat R, Clergue M, Manneville C, Saillan-Barreau C, Duriez M, Tedgui A, Levy B, Penicaud L, Casteilla L. Plasticity of human adipose lineage cells toward endothelial cells: physiological and therapeutic perspectives. Circulation. 2004 Feb 10;109(5):656-63. doi: 10.1161/01.CIR.0000114522.38265.61. Epub 2004 Jan 20. |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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