Chronic Myocardial Ischemia
Conditions
Keywords
Left Ventricular Assist Device, stem cell therapy, ischemic heart failure
Brief summary
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.
Detailed description
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
Interventions
DRUGAutologous mesenchymal stem cells
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.
Sponsors
Thoratec Corporation
University Hospital, Toulouse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Postmenopausal female or female who may become pregnant but is using adequate contraceptive precautions with negative pregnancy test, * Severe Left Ventricular dysfunction with Ejection Fraction \< 30% with ischemic cardiomyopathy, * New York Heart Association Class III or IV, * No revascularization options available, * Listed or not for cardiac transplantation, * Clinical indication and accepted candidate for Left Ventricular Assistance Device implantation as a destination therapy or as a bridge to transplantation, * Optimal medical therapy.
Exclusion criteria
* Cardiothoracic surgery within 30 days prior to study entry, * Myocardial infarction within 3 months prior to study entry, * Prior cardiac transplantation, * Left Ventricular reduction surgery or cardiomyoplasty, * Acute reversible cause of heart failure (e.g. myocarditis, profound hypothyroidism), * Left ventricular aneurysm or wall thickness preventing cell injections, * Anticipated requirement for biventricular mechanical support, * Stroke within 30 days prior to study entry, * Received investigational intervention within 30 days of study entry, * Pregnant or breastfeeding at time of study entry, * Human Imune deficiency Virus, Human T-cell Lymphotrophic Virus, Hepatitis B Virus and Hepatitis C Virus positive within 30 days prior to study entry, * Active systemic infection within 48 hours prior to study entry, * History of cancer in the last 5 years, * Patient participant to other research, * Patient under treatment that may exert an inhibitory or stimulatory effect on the growth and multiplication of cells, or with immunosuppressive properties.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the full procedure | 1 month | ability to perform bone marrow aspiration, cell culture and intramyocardial injections during left Ventricular Assist Device surgery Realization of a full injection procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Oxygen consumption | 12 months | 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, |
| Walking distance in 6 minutes | 12 months | measure of walk distance during six minutes |
| weaning procedure | 12 months | progressive reduction of the pump speed |
| Quality of life | 12 months | assessment of quality of life by Minnesota Living with Heart Failure Questionnaire |
| Measure of heart pressures | 12 months | measure of heart pressures and cardiac output |
| Ejection Fraction | 12 months | Global and regional contractile function during echocardiography |
| Troponin | 12 months | assessment of variation of troponin |
| Major bleeding | 1 month | — |
| Systemic embolism | 1 month | — |
| Deaths | 1 month | — |
| Brain natriuretic peptide | 12 months | assessment of variation of brain natriuretic peptide |
Countries
France
Outcome results
None listed