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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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.
Cardiology Department of Rangueil Hospital - Rangueil Hospital
Toulouse, France
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
Time frame: 1 month
Ejection Fraction
Global and regional contractile function during echocardiography
Time frame: 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,
Time frame: 12 months
Walking distance in 6 minutes
measure of walk distance during six minutes
Time frame: 12 months
weaning procedure
progressive reduction of the pump speed
Time frame: 12 months
Quality of life
assessment of quality of life by Minnesota Living with Heart Failure Questionnaire
Time frame: 12 months
Measure of heart pressures
measure of heart pressures and cardiac output
Time frame: 12 months
Brain natriuretic peptide
assessment of variation of brain natriuretic peptide
Time frame: 12 months
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Troponin
assessment of variation of troponin
Time frame: 12 months
Major bleeding
Time frame: 1 month
Systemic embolism
Time frame: 1 month
Deaths
Time frame: 1 month