{"id":"6ccfb8f4d8c9","type":"article","url":"https://hartvaat.nl/2017/10/14/intracoronaire-beenmergceltransfer-na-mi-de-boost-2-gerandomiseerde-trial/","title":"Intracoronaire beenmergceltransfer na MI: de BOOST-2 gerandomiseerde trial","title_en":"Intracoronary autologous bone marrow cell transfer after myocardial infarction: the BOOST-2 randomised placebo-controlled clinical trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["clear-outcomes"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehx188","source_url":"https://doi.org/10.1093/eurheartj/ehx188","authors":["Kai C Wollert","Gerd P Meyer","Jochen Müller-Ehmsen","Carsten Tschöpe","Vernon Bonarjee","Alf Inge Larsen","Andreas E May","Klaus Empen","Emmanuel Chorianopoulos","Ulrich Tebbe","Johannes Waltenberger","Heiko Mahrholdt","Benedikta Ritter","Jens Pirr","Dieter Fischer","Mortimer Korf-Klingebiel","Lubomir Arseniev","Hans-Gert Heuft","Jan E Brinchmann","Diethelm Messinger","Bernd Hertenstein","Arnold Ganser","Hugo A Katus","Stephan B Felix","Meinrad P Gawaz","Kenneth Dickstein","Heinz-Peter Schultheiss","Dennis Ladage","Simon Greulich","Johann Bauersachs"],"significance":6,"published":"2017-10-14","source_date":"2017-10-14","image":"","kennis":[],"congress":"","summary_en":"The BOOST-2 randomized placebo-controlled trial of intracoronary bone marrow cell transfer after MI showed no sustained improvement in LVEF at 6 months, adding to the neutral evidence for stem cell therapy after acute myocardial infarction.","created":"2026-07-03T10:26:56Z","updated":"2026-07-03T13:26:13Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde placebogecontroleerde BOOST-2-trial naar intracoronaire autologe beenmergceltransfer na myocardinfarct. Follow-up van het celtherapieconcept.","abstract_original":"AIMS: Intracoronary infusion of autologous nucleated bone marrow cells (BMCs) enhanced the recovery of left ventricular ejection fraction (LVEF) after ST-segment elevation myocardial infarction (STEMI) in the randomised-controlled, open-label BOOST trial. We reassessed the therapeutic potential of nucleated BMCs in the randomised placebo-controlled, double-blind BOOST-2 trial conducted in 10 centres in Germany and Norway. METHODS AND RESULTS: Using a multiple arm design, we investigated the dose-response relationship and explored whether γ-irradiation which eliminates the clonogenic potential of stem and progenitor cells has an impact on BMC efficacy. Between 9 March 2006 and 16 July 2013, 153 patients with large STEMI were randomly assigned to receive a single intracoronary infusion of placebo (control group), high-dose (hi)BMCs, low-dose (lo)BMCs, irradiated hiBMCs, or irradiated loBMCs 8.1 ± 2.6 days after percutaneous coronary intervention (PCI) in addition to guideline-recommended medical treatment. Change in LVEF from baseline (before cell infusion) to 6 months as determined by MRI was the primary endpoint. The trial is registered at Current Controlled Trials (ISRCTN17457407). Baseline LVEF was 45.0 ± 8.5% in the overall population. At 6 months, LVEF had increased by 3.3 percentage points in the control group and 4.3 percentage points in the hiBMC group. The estimated treatment effect was 1.0 percentage points (95% confidence interval, -2.6 to 4.7; P = 0.57). The treatment effect of loBMCs was 0.5 percentage points (-3.0 to 4.1; P = 0.76). Likewise, irradiated BMCs did not have significant treatment effects. BMC transfer was safe and not associated with adverse clinical events. CONCLUSION: The BOOST-2 trial does not support the use of nucleated BMCs in patients with STEMI and moderately reduced LVEF treated according to current standards of early PCI and drug therapy."}