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There has been no clinical experience in an acute setting reported using a fluoroscopically guided system for intramyocardial delivery of cell therapy.
To assess safety and efficacy of fluoroscopically guided intramyocardial transendocardial delivery of cell therapy less than 45 days after onset of acute myocardial infarction.
Patients with symptomatic heart failure following myocardial infarction (NSTEMI, STEMI) received transendocardial application of autologous bone marrow-derived mononuclear cells (BMC) 2-4 weeks after the acute event.
Patients (n=9) with LV ejection fraction (EF) of 40.1± 8.0% and NYHA Class ≥II had autologous bone marrow cell preparation performed on site employing a closed-loop system. Cells delivered were 1.3 ± 1.3% CD34+, 1.68 ± 1.58 CD117+, 0.24 ± .16 CD133+, and 0,28 ± 0.40 CD90+. Each patient received Helix transendocardial injection of BMC into the infarction border zone 28±13 days following successful interventional revascularization. Delivery procedure took 32.1±11.7 minutes to perform 9 ± 2 deliveries of in total more than 1.5x108 cells/patient around the infarcted zone; There were no treatment emergent adverse events, no MACE, no pericardial effusions, and no arrhythmias in any procedure. Endpoints derived from comparisons of baseline vs. twelve month follow-up showed improvements of NYHA class (2.6±0.5 to 1.3 ± 0.5, p = 0.0002), BNP levels (362.1 ± 340.4 to 58.9 ± 45.9 ng/l, p = 0.036), and LV EF transthoracic echocardiography measurements (40.1±8.0 to 47.4 ± 9.0%, p = 0.02).
Results support that transendocardial intramyocardial injection of BMC using Helix can be used safely in patients with symptomatic heart failure following acute ischemic events.