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| Name | Class |
|---|---|
| Thoratec Corporation | INDUSTRY |
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Left Ventricular Assist Devices are commonly used to assist failing hearts as a bridge to transplantation or for long-term support. The purpose of the MESenchymal stem cell therapy and Left Ventricular Assist Device program is to improve heart function with stem cell therapy and attempt to wean patients from HeartMate Left Ventricular Assist Device.
Currently Left Ventricular Assist Device-only patients are being implanted and followed. Feasibility of autologous mesenchymal stem cell grafting in patients receiving heart mate will be assessed in a 4 patient pilot trial. Mesenchymal stem cell are delivered during Left Ventricular Assist Device surgery by intramyocardial infusions. Recovery of contractile function of the heart is assessed during attempts to wean patients from Left Ventricular Assist Device
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| autologous mesenchymal stem cells | Experimental | After bone-marrow aspiration by an authorized person, Mesenchymal Stem Cells were isolated and cultured during 17 days by the French Blood Establishment. Then, patients receive intramyocardial injections of Mesenchymal Stem Cells during Left Ventricular Assist Device surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous mesenchymal stem cells | Drug | After bone-marrow aspiration by an authorized person, mesenchymal stem cells were isolated and cultured during 17 days by the French Blood Establishment. Then, patients receive intramyocardial injections of mesenchymal stem cells during device surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the full procedure | ability to perform bone marrow aspiration, cell culture and intramyocardial injections during left Ventricular Assist Device surgery Realization of a full injection procedure | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Ejection Fraction | Global and regional contractile function during echocardiography | 12 months |
| Maximal Oxygen consumption | Maximum rate of oxygen consumption as measured during incremental exercise, modification of the body mass (muscular lean mass, muscular strength), duration of the test and load, |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Roncalli Jérome, MD, PhD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Department of Rangueil Hospital - Rangueil Hospital | Toulouse | 31059 | France |
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| 12 months |
| Walking distance in 6 minutes | measure of walk distance during six minutes | 12 months |
| weaning procedure | progressive reduction of the pump speed | 12 months |
| Quality of life | assessment of quality of life by Minnesota Living with Heart Failure Questionnaire | 12 months |
| Measure of heart pressures | measure of heart pressures and cardiac output | 12 months |
| Brain natriuretic peptide | assessment of variation of brain natriuretic peptide | 12 months |
| Troponin | assessment of variation of troponin | 12 months |
| Major bleeding | 1 month |
| Systemic embolism | 1 month |
| Deaths | 1 month |