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Ketil Lunde , Rikshospitalet University Hospital, Oslo, Norway

Intracoronary injection of mononuclear bone marrow cells after acute myocardial infarction Lessons from the ASTAMI trial. Ketil Lunde , Rikshospitalet University Hospital, Oslo, Norway The 4th Symposium on Stem Cell Therapy and Cardiovascular Biology, Madrid, 26 th April 2007.

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Ketil Lunde , Rikshospitalet University Hospital, Oslo, Norway

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  1. Intracoronary injection of mononuclear bone marrow cells after acute myocardial infarctionLessons from the ASTAMI trial Ketil Lunde, Rikshospitalet University Hospital, Oslo, Norway The 4th Symposium on Stem Cell Therapy and Cardiovascular Biology, Madrid, 26thApril 2007 Presenter disclosure information : No conflicts of interest

  2. Background Nature 2001;410:701-705 Circulation 2002;106:1913-1918

  3. Study power • Primary end-point: LVEF • 5 % difference between groups of the ∆ LVEF (Baseline – 6 months) by SPECT • 80 % power, significance level 5 %

  4. Study design Day 0: Acute Anterior Wall Myocardial Infarction PCI with stent on LAD culprit lesion Day 3-5: Randomization Control group n=50 mBMC group n=50 Day 4-7: Baseline recordings, 99mTc-MIBI SPECT, Echocardiography Day 4-8: Bone marrow aspiration and intracoronary mBMC injection 2-3 weeks: MRI, bicycle exercise tests, SF-36 3 months follow up: Echocardiography 6 months follow-up: 99mTc-MIBI SPECT, Echocardiography, MRI, Coronary angiography, SF-36 12 months follow up: Echocardiography

  5. Cell harvesting and preparation • Local anesthesia • Aspirated volume: 50 ml • Density gradient centrifugation on ficoll-hypaque • mBMC: 68 x 106 cells • CD34+ cells: 0.7 x 106 • Viability: 95 % • GMP accredited laboratory Values are median

  6. Cell preparation in ASTAMI • The ASTAMI Study protocol for • Isolation of mononuclear cells • Overnight storage • Viability testing • Proven successful for treatment of patients with hematological diseases Egeland et al, Eur Heart J 2007;letter to editor (in press)

  7. Intracoronary mBMC injection • Time point • 6.0 (1.3) days after PCI • Total volume injected • 10 ml mBMC suspension • Procedure • Over-the-wire balloon • balloon inflation for 1.5 min with no-flow and distal injection of apprx 3.3ml mBMC suspension • injections repeated twice with 5 min re-flow between balloon inflations

  8. Baseline characteristics Values are mean (SD), proportion (%) or *median (interquartile range)

  9. Medication at discharge

  10. Change in LVEF SPECT Echocardiography MRI Values are mean with SEM error bars, p = ANCOVA N Engl J Med 2006;355:1199-1209

  11. Dose-response

  12. Change in Infarct Size SPECT MRI Values are mean with SEM error bars, p = ANCOVA Lunde et al, N Engl J Med 2006;355:1199-1209

  13. Change in exercise capacity Values are mean with SEM error bars, p = ANCOVA Lunde et al, Eur Heart J 2006;27(Suppl 1):280[abstract#1680)

  14. 12 months follow-up mBMC Control *p = SPSS mixed models for difference between groups over time Lunde et al, AHA Scientific Sessions 2006; Abstract#2717

  15. Moller et al. Am Heart J 2006;151:419-425

  16. 12 months follow-up mBMC Control *p = SPSS mixed models for difference between groups over time Lunde et al, AHA Scientific Sessions 2006; Abstract#2717

  17. 12 months clinical follow-up Values are number of patients

  18. Interleukin 6 Values are median (picog/L), p=ANCOVA for the change between groups Solheim et al, JACC 2007;49(Suppl 1):189[abstract#1001-132]

  19. Conclusion I • In this randomized trial investigating effects of intracoronary injections of autologous bone marrow cells after acute MI • There was a similar improvement in LV function • The clinical outcome was excellent • Adverse event rates were similar and low • In both groups during 12 months follow-up

  20. Results on LVEF in randomized BMC trials

  21. Clinical follow-up in BMC trials

  22. Conclusion II • Intracoronary administration of BMC after AMI seems to be safe • Efficacy is not established • Results of ongoing adequately powered studies with accurate assessment of LV function are awaited

  23. ASTAMI investigators • Steering committee • K Forfang (chair), S Aakhus, H Arnesen, T Egeland, K Endresen, A Ilebekk, • A Mangschau • Study investigators • S Aakhus, M Abdelnoor, H Arnesen, P Aukrust, R Bjørnerheim, M Brekke, • L Brinch, JE Brinchmann, T Egeland, K Endresen, JG Fjeld, K Forfang, • HK Grøgaard, E Hopp, A Ilebekk, TO Kjellevand, NE Kløw, K Lunde, A Mangschau, C Mϋller, A Ragnarsson, I Seljeflot, HJ Smith, S Solheim, E Taraldsrud • Data and safety monitoring board • K Rasmussen, L Wallentin, R Wiseth • Acknowledgements • K Lunde and S Solheim are recipients of research fellowships from the Norwegian Council on Cardiovascular diseases

  24. TOPCARE-AMI Britten et al, Circulation 2003;108:2212-2218

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