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Myocardial Recovery: Stem Cell Therapy - are we getting there?

Myocardial Recovery: Stem Cell Therapy - are we getting there?. Professor Anthony Mathur Queen Mary University of London Barts and the London NHS Trust. Yes. efficacy. preclinical promise?. Source and Administration in AMI Trials.

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Myocardial Recovery: Stem Cell Therapy - are we getting there?

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  1. Myocardial Recovery:Stem Cell Therapy - are we getting there? Professor Anthony Mathur Queen Mary University of London Barts and the London NHS Trust

  2. Yes

  3. efficacy

  4. preclinical promise?

  5. Source and Administration in AMI Trials Dimmeler S, Zeiher AM, Schneider MD J Clin Invest 2005:115;572.

  6. RCT using BMC post MI Effect on LVEF MI Size CHF TOPCARE-CHF +2.9% (p<0.01) ND BOOST ND +6.0% (p<0.01) +2.8% (p=ns)* ASTAMI p=ns +0.6% (p=ns) AMI REPAIR-AMI +2.5% (p=0.01) ND -28% (p=0.03) LEUVEN-AMI +1.2% (p=ns) 1 10 100 1000 Timing of BMC Transfer post MI [Days post MI] * 18 months follow-up

  7. Meta-analysis of randomised placebo control trials 3% Martin-Rendon et al., 2008, Eur Heart J, 29, 1807-18

  8. Discrepancy? • Not enough cells injected in man • Wrong cells • Wrong timing relative to infarct age • Wrong delivery method • Animal models not representative

  9. Δ LVEF and outcome?

  10. RCT using BMC post MI MI Size Effect on LVEF TOPCARE-CHF +2.9% (p<0.01) ND CHF REGENERATE-IHD ******* BOOST ND +6.0% (p<0.01) +2.8% (p=ns)* ASTAMI p=ns +0.6% (p=ns) AMI REPAIR-AMI +2.5% (p=0.01) ND -28% (p=0.03) LEUVEN-AMI +1.2% (p=ns) REGENERATE-AMI ******* 0 1 10 100 1000 10000 Timing of BMC Transfer post MI [Days post MI] * 18 months follow-up

  11. REGENERATE-AMI ?

  12. Preliminary results

  13. REGENERATE-IHD P=0.2 P=0.006 * p = 0.0057 p = 0.1887

  14. 0 1.0 12 24 36 48 60 0.8 0.6 0.4 0.2 0.0 NYHA class vs. prognosis Log rank test P<0.001 NYHA IV NYHA III Cumulative risk of all-cause mortality (%) NYHA II NYHA I Follow up in months

  15. safety

  16. Primary PCI Lancet. 2007 Jun 30;369(9580):2142-3

  17. technique

  18. Epicardium Intravenous Intra-arterial Mobilised intramyocardium Coronary artery Coronary sinus Delivery Routes INDIRECT DIRECT

  19. REGENERATE-IHD P=0.2 P=0.006 * p = 0.0057 p = 0.1887

  20. Summary • Stem cells for myocardial recovery - we could already be there • Results of more outcome studies needed • Important questions for translational research • Clinicians need to agree on acceptable outcome measures

  21. Clinical importance vs statistical significance? ‘……..in contrast to the well-established standards for statistical significance (p values), no guidelines exist for deciding what magnitude of difference is clinically significant or practically important.’ J Am Coll Cardiol 2010; 55:415-27.

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