Transendocardial autologous bone marrow in myocardial infarction induced heart failure, two-year follow-up in an open-label phase I safety study (the TABMMI study)

To assess the hypothesis that fluoroscopically-guided helical needle transendocardial delivery of autologous bone marrow (ABM) mononuclear cells (MNCs) in chronic post myocardial infarction patients is safe and improves ejection fraction (EF). Twenty ischaemic heart failure patients with an EF ≤40%...

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Bibliographic Details
Published in:	EuroIntervention Vol. 7; no. 7; pp. 805 - 812
Main Authors:	DE LA FUENTE, Luis M, STERTZER, Simon H, ARGENTLERI, Julio, PENALOZA, Eduardo, KOZINER, Benjamin, ROUY, Didier, ALTMAN, Peter A
Format:	Journal Article
Language:	English
Published:	Toulouse Société Europa Edition 01-11-2011
Subjects:	Aged Argentina Biological and medical sciences Bone Marrow Transplantation - adverse effects Bone Marrow Transplantation - instrumentation Cardiology. Vascular system Catheters Coronary heart disease Echocardiography Electrocardiography, Ambulatory Equipment Design Exercise Test Exercise Tolerance Female Fluoroscopy Heart Heart Failure - diagnosis Heart Failure - etiology Heart Failure - physiopathology Heart Failure - surgery Heart failure, cardiogenic pulmonary edema, cardiac enlargement Humans Injections Male Medical sciences Middle Aged Myocardial Infarction - complications Myocardial Infarction - diagnosis Myocardial Infarction - physiopathology Myocardial Infarction - surgery Myocarditis. Cardiomyopathies Needles Radiography, Interventional Recovery of Function Stroke Volume Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Time Factors Transplantation, Autologous Treatment Outcome Ventricular Function, Left Argentina Myocardial infarction Heart failure Catheter Cardiovascular disease Autologous system Transplantation Homotransplantation Coronary heart disease Myocardial disease Treatment Follow up study Surgery cell therapy Phase I trial Bone marrow Graft Complication Safety catheters Cell
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Summary:	To assess the hypothesis that fluoroscopically-guided helical needle transendocardial delivery of autologous bone marrow (ABM) mononuclear cells (MNCs) in chronic post myocardial infarction patients is safe and improves ejection fraction (EF). Twenty ischaemic heart failure patients with an EF ≤40% were enrolled. ABMMNCs were prepared, counted for CD34+ and CD133+ content, and delivered percutaneously to the heart at 5 to 10 peri-infarct sites. Two-dimensional (2D) transthoracic echocardiography, EF measurements, Holter, and exercise tolerance time (ETT) were performed at baseline, one week (wk), and 6, 12, and 24 months (mo). 96±29 million ABMMNCs were injected into 8.5±2.6 peri-infarct sites over 42±17 minutes (n=20). There were no adverse events associated with the catheter-based cell transplantation procedure or significant increases in ventricular events on Holter. EF improved over baseline from 34.9±4.3% to 41.9±5.1% at 12 mo to 42.2±7.1% (p=0.00005) at 24 mo. ETT improvements were statistically significant from 246±113 sec to 373±183 sec at 12 mo and 371±181 sec at 24 mo (p=0.006). ABMMNCs delivered with the helical needle transendocardial catheter was safe in this uncontrolled open label study. Increased EF and ETT support the safety of the procedure and technologies involved and warrant additional investigation.
ISSN:	1774-024X 1969-6213
DOI:	10.4244/EIJV7I7A127