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Safety of granulocyte-colony-stimulating factor in acute myocardial infarction (the Rigenera study)
  1. A M Leone1,
  2. L Galiuto1,
  3. S Rutella2,
  4. M B Giannico1,
  5. S Brugaletta1,
  6. B Garramone1,
  7. V De Stefano2,
  8. G Liuzzo1,
  9. M L Calcagni3,
  10. F Cirillo3,
  11. A Giordano3,
  12. G Niccoli1,
  13. L M Biasucci1,
  14. A G Rebuzzi1,
  15. G Leone2,
  16. F Crea1
  1. 1Institute of Cardiology, Catholic University of the Sacred Heart, Rome, Italy
  2. 2Institute of Haematology, Catholic University of the Sacred Heart, Rome, Italy
  3. 3Institute of Nuclear Medicine, Catholic University of the Sacred Heart, Rome, Italy
  1. Correspondence to:
    A M Leone
    Institute of Cardiology, Catholic University of the Sacred Heart, Largo A Gemelli 8, Rome 00168, Italy; antoniomarialeone{at}

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Intracoronary administration of bone marrow stem cells can improve left ventricular function after acute myocardial infarction (AMI)1; however, it is invasive and therefore not widely applicable. Moreover, we have recently shown that the CD34 cell count is favourably correlated with left ventricular function changes after AMI.2 Granulocyte-colony stimulating factor (G-CSF), a potent mobiliser of CD34 stem cells, might improve left ventricular function through their increased concentration.

Yet, a recent report raised concern about the safety of early G-CSF administration after AMI, followed by intracoronary cell injection and infarct-related artery (IRA) stenting, because of a strikingly high restenosis rate.3

The aim of our study was to assess the safety and the potential efficacy on cardiac function and perfusion of G-CSF administration in patients with a first large AMI.


We enrolled eight patients with a first anterior AMI (all men, mean (standard deviation (SD)) age 54 (11) years, peak creatinine kinase 4615 (3998) UI/l). Successful stenting of IRA within 7 days and left ventricular ejection fraction <45%. Exclusion criteria were cardiogenic shock, uncontrolled myocardial ischaemia or arrhythmias, malignancies, severe infections, haematological diseases, splenomegaly at abdominal echography and age >80 years. All patients were treated with lenograstim (recombinant human G-CSF) at a dose of 10 μg/kg/day for 5 days starting 5 days after coronary stenting. During hospitalisation and at 3 and 6 months, the occurrence of major adverse cardiac events (death, re-infarction and recurrence of angina) and myocardial …

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  • Funding: This study was supported by a grant from the Fondazione Cassa di Risparmio di Roma to UNICATT Cord Blood Bank of the Catholic University of the Sacred Heart of Rome and by Fondazione Internazionale Ricerche Per il Cuore, ONLUS, Rome.

  • Competing interests: None.

  • Lenograstim (Myelostim 34) was supplied by Italfarmaco SpA (Milan, Italy), which had no role in the collection, analysis and interpretation of the data.