Wollert, Kai C., Meyer, Gerd P., Mueller-Ehmsen, Jochen, Tschope, Carsten, Bonarjee, Vernon, Larsen, Alf Inge, May, Andreas E., Empen, Klaus, Chorianopoulos, Emmanuel, Tebbe, Ulrich, Waltenberger, Johannes, Mahrholdt, Heiko, Ritter, Benedikta, Pirr, Jens, Fischer, Dieter, Korf-Klingebiel, Mortimer, Arseniev, Lubomir, Heuft, Hans-Gert, Brinchmann, Jan E., Messinger, Diethelm, Hertenstein, Bernd, Ganser, Arnold, Katus, Hugo A., Felix, Stephan B., Gawaz, Meinrad P., Dickstein, Kenneth, Schultheiss, Heinz-Peter, Ladage, Dennis ORCID: 0000-0002-4512-0917, Greulich, Simon and Bauersachs, Johann (2017). Intracoronary autologous bone marrow cell transfer after myocardial infarction: the BOOST-2 randomised placebo-controlled clinical trial. Eur. Heart J., 38 (39). S. 2936 - 2944. OXFORD: OXFORD UNIV PRESS. ISSN 1522-9645

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Abstract

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 gamma-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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Wollert, Kai C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Meyer, Gerd P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mueller-Ehmsen, JochenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tschope, CarstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bonarjee, VernonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Larsen, Alf IngeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
May, Andreas E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Empen, KlausUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chorianopoulos, EmmanuelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tebbe, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Waltenberger, JohannesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mahrholdt, HeikoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ritter, BenediktaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pirr, JensUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fischer, DieterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Korf-Klingebiel, MortimerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Arseniev, LubomirUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heuft, Hans-GertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brinchmann, Jan E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Messinger, DiethelmUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hertenstein, BerndUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ganser, ArnoldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Katus, Hugo A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Felix, Stephan B.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gawaz, Meinrad P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dickstein, KennethUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schultheiss, Heinz-PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ladage, DennisUNSPECIFIEDorcid.org/0000-0002-4512-0917UNSPECIFIED
Greulich, SimonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bauersachs, JohannUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-214261
DOI: 10.1093/eurheartj/ehx188
Journal or Publication Title: Eur. Heart J.
Volume: 38
Number: 39
Page Range: S. 2936 - 2944
Date: 2017
Publisher: OXFORD UNIV PRESS
Place of Publication: OXFORD
ISSN: 1522-9645
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
LEFT-VENTRICULAR FUNCTION; MONONUCLEAR-CELLS; THERAPY; INJECTION; REGENERATION; GUIDELINES; ELEVATION; INFUSION; DELIVERY; INSIGHTSMultiple languages
Cardiac & Cardiovascular SystemsMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/21426

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