title: Combined delivery approach of bone marrow mononuclear stem cells early and late after myocardial infarction: the MYSTAR prospective, randomized study.
abstract: BACKGROUND
  Combined intracoronary and intramyocardial administration might improve outcomes for bone-marrow-derived stem cell therapy for acute myocardial infarction (AMI). We compared the safety and feasibility of early and late delivery of stem cells with combined therapy approaches.
  
  
  METHODS
  Patients with left ventricular ejection fraction less than 45% after AMI were randomly assigned stem cell delivery via intramyocardial injection and intracoronary infusion 3-6 weeks or 3-4 months after AMI. Primary end points were changes in infarct size and left ventricular ejection fraction 3 months after therapy.
  
  
  RESULTS
  A total of 60 patients were treated. The mean changes in infarct size at 3 months were -3.5 +/- 5.1% (95% CI -5.5% to -1.5%, P = 0.001) in the early group and -3.9 +/- 5.6% (95% CI -6.1% to -1.6%, P = 0.002) in the late group, and changes in ejection fraction were 3.5 +/- 5.6% (95% CI 1.3-5.6%, P = 0.003) and 3.4 +/- 7.0% (95% CI 0.7-6.1%, P = 0.017), respectively. At 9-12 months after AMI, ejection fraction remained significantly higher than at baseline in both groups. In the early and late groups, a mean of 200.3 +/- 68.7 x 10(6) and 194.8 +/- 60.4 x 10(6) stem cells, respectively, were delivered to the myocardium, and 1.30 +/- 0.68 x 10(9) and 1.29 +/- 0.41 x 10(9) cells, respectively, were delivered into the artery. A high number of cells was required for significant improvements in the primary end points.
  
  
  CONCLUSIONS
  Combined cardiac stem cell delivery induces a moderate but significant improvement in myocardial infarct size and left ventricular function.
authors.affiliation: Department of Cardiology, Medical University of Vienna, Austria. mariann.gyongyosi@meduniwien.ac.at
authors.forename: Mariann
authors.initials: M
authors.lastname: Gyöngyösi
authors.forename: Irene
authors.initials: I
authors.lastname: Lang
authors.forename: Markus
authors.initials: M
authors.lastname: Dettke
authors.forename: Gilbert
authors.initials: G
authors.lastname: Beran
authors.forename: Senta
authors.initials: S
authors.lastname: Graf
authors.forename: Heinz
authors.initials: H
authors.lastname: Sochor
authors.forename: Noémi
authors.initials: N
authors.lastname: Nyolczas
authors.forename: Silvia
authors.initials: S
authors.lastname: Charwat
authors.forename: Rayyan
authors.initials: R
authors.lastname: Hemetsberger
authors.forename: Günter
authors.initials: G
authors.lastname: Christ
authors.forename: István
authors.initials: I
authors.lastname: Edes
authors.forename: László
authors.initials: L
authors.lastname: Balogh
authors.forename: Korff Thomas
authors.initials: KT
authors.lastname: Krause
authors.forename: Kai
authors.initials: K
authors.lastname: Jaquet
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Kuck
authors.forename: Imre
authors.initials: I
authors.lastname: Benedek
authors.forename: Theodora
authors.initials: T
authors.lastname: Hintea
authors.forename: Róbert
authors.initials: R
authors.lastname: Kiss
authors.forename: István
authors.initials: I
authors.lastname: Préda
authors.forename: Vladimir
authors.initials: V
authors.lastname: Kotevski
authors.forename: Hristo
authors.initials: H
authors.lastname: Pejkov
authors.forename: Sholeh
authors.initials: S
authors.lastname: Zamini
authors.forename: Aliasghar
authors.initials: A
authors.lastname: Khorsand
authors.forename: Gottfried
authors.initials: G
authors.lastname: Sodeck
authors.forename: Alexandra
authors.initials: A
authors.lastname: Kaider
authors.forename: Gerald
authors.initials: G
authors.lastname: Maurer
authors.forename: Dietmar
authors.initials: D
authors.lastname: Glogar
mesh_terms: D000328:Adult; D000368:Aged; D016026:Bone Marrow Transplantation; D005060:Europe; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D009206:Myocardium / Q000473:pathology*; D011446:Prospective Studies; D016037:Single-Blind Method; D033581:Stem Cell Transplantation; D013318:Stroke Volume; D013997:Time Factors; D015899:Tomography, Emission-Computed, Single-Photon; D016896:Treatment Outcome; D016277:Ventricular Function, Left