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Filippo Crea Institute of Cardiology Catholic University of the Sacred Heart Rome , Italy

Heartline. Trial sulla terapia cellulare : end-point strumentali o clinici ?. Filippo Crea Institute of Cardiology Catholic University of the Sacred Heart Rome , Italy. Evidence that human cardiac myocites divide afte AMI in man. (Beltrami, et al NEJM 2001). VEGF. G-CSF. C-Kit.

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Filippo Crea Institute of Cardiology Catholic University of the Sacred Heart Rome , Italy

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  1. Heartline Trial sullaterapiacellulare: end-point strumentali o clinici? Filippo Crea Institute of Cardiology CatholicUniversity of the SacredHeart Rome, Italy

  2. Evidence that human cardiac myocites divide afte AMI in man (Beltrami, et al NEJM 2001)

  3. VEGF G-CSF C-Kit MMP-9 SDF-1 SCF HGF CXCR4 CD34 KDR CXCR4 C-Met C-Kit CD34 CD133 C-Met C-Kit KDR

  4. p<0.001 p=0.036 40 p<0.001 30 CD34+ cells/ml 20 10 0 AMI (n=54) CSA (n=26) Controls (n=43) CD 34+ cell mobilization in different coronary syndromes (Leone et al, submitted to EHJ)

  5. Correlation between improvement of LV function and CD 34+ cells at 1-yr FU (Leone et al, EHJ 2005)

  6. Whichstemcells?

  7. Which elivery methods?

  8. Which patients? • Myocardial infarction • Heart Failure • Refractory angina

  9. Back to GISSI 1 (Volpi et al, Circulation 1993)

  10. Effects of enalapril on long-term progression of left ventricular dysfunction in patients with heart (SOLVD, Circulation 1992)

  11. Room for improvement • Celltype • Cell preparation • Myocardialhoming • Administration timing • Delivery method • Patientselection

  12. Humancardiacstemcell (Urbaneket al, PNAS 2006)

  13. Pharmacological BM-SC mobilization CD34+/KDR+EPCs (n/ml) (Leone et al IJC 2008)

  14. Targeted Migration of Mesenchymal Stem Cells Modified With CXCR4 Gene to Infarcted MyocardiumImproves Cardiac Performance (Cheng et al MolTher2008)

  15. Timing of intracoronary injection and LVEF in REPAIR-AMI (Schachingeret al, NEJM 2006)

  16. Comparison of different delivery methods (Caplice et al, Journal of Nucl. Medicine 2007)

  17. Patient selection in REPAIR-AMI (Schachingeret al, NEJM 2006)

  18. Surrogate end-points: negative results (ASPIRE, EHJ 2011)

  19. Surrogate end-points: positive results • Flecainide in post-AMI • Reducesventricularectopicbeats • Increasesmortality (CAST trial, NEJM 1991) • Ibopamine in severe HF • Improvescardiacfunction • Increasesmortality (PRIME II trial, Lancet 1997) • Torcetrapib in dyslipedemia • Improveslipidprofile • Increasesmortality (ILLUMINATE, NEJM 2007)

  20. Time for clinical end-points • BAMI • BMSC • STEM-AMI OUTCOME • G-CSF

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