title: Intramyocardial injection of bone marrow mononuclear cells in chronic myocardial ischemia patients after previous placebo injection improves myocardial perfusion and anginal symptoms: an intra-patient comparison.
abstract: BACKGROUND
  We recently demonstrated in a randomized, double-blind, placebo-controlled trial that intramyocardial bone marrow cell (BMC) injection is associated with improvements in myocardial perfusion and anginal symptoms in chronic myocardial ischemia patients. In the present study the results of the crossover phase of this trial, in which patients previously treated with placebo received autologous BMC injections are reported. This allows a unique intra-patient comparison on the effect of BMC versus placebo injection with elimination of patient-related confounding factors.
  
  
  METHODS
  In 16 patients (14 male, 64 ± 10 years), who previously received intramyocardial placebo injections in the setting of a randomized trial, 100 × 10(6) BMC were injected using the NOGA-system. Canadian Cardiovascular Society angina score and quality of life were evaluated at baseline, 3 and 6 months. Tc-99m single photon emission computed tomography and magnetic resonance imaging were performed at baseline and 3 months to assess myocardial perfusion and left ventricular (LV) function.
  
  
  RESULTS
  Canadian Cardiovascular Society score and quality of life improved significantly after BMC injection as compared to placebo (P = 0.01 and P = 0.02, respectively). Single photon emission computed tomography revealed a significant greater improvement (P = 0.03) in summed stress score after BMC injection as compared to placebo. LV end-systolic volume significantly decreased after BMC injection but not after placebo injection. LV end-diastolic volume and LV ejection fraction did not change.
  
  
  CONCLUSIONS
  Intramyocardial BMC injection in patients with chronic myocardial ischemia who previously received intramyocardial placebo treatment resulted in significant improvement in angina symptoms and myocardial perfusion. These results confirm the outcome of our previously reported randomized trial.
authors.affiliation: Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Sander F
authors.initials: SF
authors.lastname: Rodrigo
authors.forename: Jan
authors.initials: J
authors.lastname: van Ramshorst
authors.forename: Saskia L
authors.initials: SL
authors.lastname: Beeres
authors.forename: Imad
authors.initials: I
authors.lastname: Al Younis
authors.forename: Petra
authors.initials: P
authors.lastname: Dibbets-Schneider
authors.forename: Albert
authors.initials: A
authors.lastname: de Roos
authors.forename: Willem E
authors.initials: WE
authors.lastname: Fibbe
authors.forename: Jaap J
authors.initials: JJ
authors.lastname: Zwaginga
authors.forename: Martin J
authors.initials: MJ
authors.lastname: Schalij
authors.forename: Jeroen J
authors.initials: JJ
authors.lastname: Bax
authors.forename: Douwe E
authors.initials: DE
authors.lastname: Atsma
mesh_terms: D000368:Aged; D000787:Angina Pectoris / Q000517:prevention & control*; D001854:Bone Marrow Cells; D002908:Chronic Disease; D003326:Coronary Circulation; D018592:Cross-Over Studies; D005260:Female; D006334:Heart Function Tests; D006801:Humans; D007267:Injections; D007963:Leukocytes, Mononuclear; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D009206:Myocardium; D011788:Quality of Life; D012107:Research Design; D012720:Severity of Illness Index; D015899:Tomography, Emission-Computed, Single-Photon; D016896:Treatment Outcome; D016277:Ventricular Function, Left