title: Impact of cell number and microvascular obstruction in patients with bone-marrow derived cell therapy: final results from the randomized, double-blind, placebo controlled intracoronary Stem Cell therapy in patients with Acute Myocardial Infarction (SCAMI) trial.
abstract: BACKGROUND
  In patients with acute myocardial infarction (AMI), the number of transplanted autologous bone-marrow cells (BMC) has been linked to improvement in left ventricular ejection fraction (LVEF). Complete obstruction of myocardial microvasculature is indicated by microvascular obstruction (MO) in cardiac magnetic resonance imaging (CMR). We analyzed whether the number of transplanted cells and presence of MO were associated with improved LVEF in the double-blind, placebo-controlled, randomized intracoronary Stem Cell therapy in patients with Acute Myocardial Infarction (SCAMI) trial.
  
  
  RESULTS
  Patients (N = 42) received study therapy mean 7 days after AMI. Median number of transplanted BMC was 324 × 10(6). CMR was performed prior to study therapy and annually up to 3 years and revealed no difference between BMC and placebo population. Patients treated with a cell number above the median experienced a significant improvement in LVEF compared with patients with cell number below the median 3.6 ± 3.4 versus -0.5 ± 6.4 % (difference 4.1, 95 % CI 0.2 to 8.1 %, p = 0.04) at 6 months. The difference in LVEF change between the groups remained with 3.8 % (p = 0.12) at 12 months, 4.5 % (p = 0.07) at 24 months and 5.6 % (p = 0.03) at 36 months. BMC treated patients without MO experienced a better improvement in LVEF compared with patients with MO at 6, 12, 24 and 36 months with 3.5, 5.3, 6.4 and 3.2 %.
  
  
  CONCLUSIONS
  In the randomized, placebo-controlled double-blind SCAMI trial improvement in LVEF up to 3 years was higher in BMC patients treated with a high cell number or without MO.
authors.affiliation: Clinic for Internal Medicine II, University of Ulm, Ulm, Germany, jochen.woehrle@uniklinik-ulm.de.
authors.forename: Jochen
authors.initials: J
authors.lastname: Wöhrle
authors.forename: Fabian
authors.initials: F
authors.lastname: von Scheidt
authors.forename: Peter
authors.initials: P
authors.lastname: Schauwecker
authors.forename: Markus
authors.initials: M
authors.lastname: Wiesneth
authors.forename: Sinisa
authors.initials: S
authors.lastname: Markovic
authors.forename: Hubert
authors.initials: H
authors.lastname: Schrezenmeier
authors.forename: Vinzenz
authors.initials: V
authors.lastname: Hombach
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Rottbauer
authors.forename: Peter
authors.initials: P
authors.lastname: Bernhardt
mesh_terms: D016026:Bone Marrow Transplantation / Q000379:methods*; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D008279:Magnetic Resonance Imaging; D008833:Microcirculation; D008875:Middle Aged; D009203:Myocardial Infarction / Q000503:physiopathology / Q000628:therapy*; D033581:Stem Cell Transplantation / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000503:physiopathology / Q000628:therapy*
references.citation: Eur Heart J. 2009 Aug;30(16):2011-8
references.pmid: 19633015
references.citation: Am Heart J. 2006 Nov;152(5):975.e9-15
references.pmid: 17070173
references.citation: J Cell Mol Med. 2012 Sep;16(9):2112-6
references.pmid: 22225626
references.citation: Eur Heart J. 2008 Aug;29(15):1807-18
references.pmid: 18523058
references.citation: Eur Heart J. 2005 Mar;26(6):549-57
references.pmid: 15713695
references.citation: Eur J Heart Fail. 2012 Jan;14(1):91-105
references.pmid: 22065869
references.citation: Lancet. 2012 Mar 10;379(9819):895-904
references.pmid: 22336189
references.citation: JAMA. 2011 Nov 16;306(19):2110-9
references.pmid: 22084195
references.citation: Cochrane Database Syst Rev. 2012 Feb 15;(2):CD006536
references.pmid: 22336818
references.citation: JAMA. 2012 Mar 14;307(10):1022-3; author reply 1023-4
references.pmid: 22416092
references.citation: J Am Coll Cardiol. 2011 Sep 6;58(11):1095-104
references.pmid: 21884944
references.citation: Am J Cardiol. 2010 Mar 15;105(6):804-12
references.pmid: 20211323
references.citation: Catheter Cardiovasc Interv. 2012 Jun 1;79(7):1083-9
references.pmid: 22162175
references.citation: Circ Res. 2012 Jan 20;110(2):304-11
references.pmid: 22052917