The trial enrolled 200 patients post AMI treated with successful PCI, with LVEF ≤45% randomized to placebo, to receive early (before 7 days) or late (after 7 days) stem cells infusion. Primary end point was LVEF at 4 months. At follow up, stem cells infusion, both early and late, did not improve LVEF, compared to…
PILOT trial: Pilot study of two levels of hypothermia in comatose survivors after out-of-hospital cardiorespiratory arrest.
Hypothermia is neuroprotective, because it reduces brain oxygen consumption in 6%, suppresses chemical reactions associated to reperfusion, reduces free radicals and mitochondrial damage. It has already been proved useful when implemented late after cardiac arrest, and its immediate use could be more beneficial. Adverse effects such as cardiac arrhythmia, infection and coagulopathy lead to abandon…
SCIPIO trial: Intracoronary infusion of autologous cardiac stem cells improve ventricular function.
This is the first trial that used autologous cardiac stem cells for the treatment of ischemic cardiomyopathy. It consecutively enrolled 37 patients with reduced ejection fraction (lower than 40%) before myocardial revascularization surgery. It was administered by intra coronary infusion and 17 were control subjects. In the group injected with stem cells, EF significantly improved…
POSEIDON: Transendocardial infusion of autologous vs. allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy.
Safety and efficacy of autologous vs. allogeneic mesenchymal stem cells had not yet been compared. This trial randomized 30 patients with LV dysfunction due to ischemic cardiomyopathy to receive transendocardial infusion of allogeneic vs. autologous mesenchymal stem cells. At 13 months, adverse events were 33.3% for the allogeneic group vs. 53.3% for the autologous group…
TIME: Use and duration of bone marrow derived stem cells infusion for the treatment of post infarction ventricular dysfunction.
This study randomized 120 patients with acute myocardial infarction after successful primary angioplasty with a residual ejection fraction (LVEF) <45%. An intracoronary infusion with fixed doses of bone marrow derived stem cells vs. placebo was administered (randomization 2:1) 3 days after infarction vs. 7 (randomization 1:1). The objective was to assess ventricular and contractile function…
ALCADIA: An intra-myocardial injection of autologous cardiac derived stem cells improves ventricular function in patients with ischemic cardiomyopathy.
This is an open trial that included 7 patients with ischemic cardiomyopathy and reduced the ejection fraction (between15% and 35%) administered via intra-myocardial injection with autologous cardiac derived stem cells. Security end points were major cardiac events and efficacy end point was ejection fraction (EF) improvement. At 24 weeks, one of the patients presented a…