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SEISMIC Trial

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  1. SEISMIC Trial The Safetyand Effects of Implanted (Autologous) Skeletal Myoblasts (MyoCell) using an Injection Catheter Trial

  2. SEISMIC Trial SEISMIC Trial Presented at ACC / i2 2008 in Chicago Presented by Dr. Patrick W. Serruys Copyleft Clinical Trial Results. You Must Redistribute Slides

  3. SEISMIC Trial: Background • Evaluated the safety and efficacy of injecting patient’s own skeletal muscle cells into scarred myocardium using a needle-tipped catheter. • Skeletal muscle cells have been shown to be superior to other muscle cell types in pre-clinical studies¹. ¹ E. Meliga, HJ Duckers, R Spencer, PW Serruys. Rationale and interim analysis data from the SEISMIC study. EuroIntervention Supplement (2007) 2 B84-B88. Presented at SCAI/ACC i2 08 Summit

  4. SEISMIC Trial: Study Design 47 patients with congestive heart failure prior to randomization Prospective. Randomized. Multicenter. Mean follow-up 6 months 66% received cell therapy and 34% received optimal medical treatment. R Cell therapy 586 ± 193 x 106 cells n=31 Optimal medical treatment n=16 6 mos. follow-up • Primary Safety Endpoint: Incidence of procedural and device related serious adverse events. • Efficacy Endpoints: Change in global LVEF by MUGA scan, change in NYHA classification of heart failure, distance achieved during 6 minute walk test. Copyleft Clinical Trial Results. You Must Redistribute Slides Presented at SCAI-ACCi2 08 Summit

  5. SEISMIC Trial: Primary Safety Endpoint • There were 15 incidences of sustained arrhythmia in the cell therapy group vs. 14 incidences in the medical treatment control group. Incidence of adverse events Presented at SCAI/ACC i2 08 Summit Copyleft Clinical Trial Results. You Must Redistribute Slides


  6. SEISMIC Trial: Efficacy Endpoint • The cell therapy group was able to walk an additional 60.3 ± 54.1 meters in the 6 minute walk test. • The medical therapy group walked an additional 0.4 ± 185.7 meters in the same test. Copyleft Clinical Trial Results. You Must Redistribute Slides Presented at SCAI/ACC i2 08 Summit

  7. SEISMIC Trial: Efficacy Endpoint cont. NYHA HF status deterioration (%) NYHA HF status improvement (%) n =5 n =1 n =3 n =1 Medical treatment Cell therapy Medical treatment Cell therapy Copyleft Clinical Trial Results. You Must Redistribute Slides Presented at SCAI-ACC i2 Summit

  8. SEISMIC Trial: Efficacy Endpoint at 6 months • Global ejection fraction was higher in the medical treatment group compared to the cell therapy group after 6 month follow-up. Global EF (%) Presented at SCAI-ACC i2 08 Summit Copyleft Clinical Trial Results. You Must Redistribute Slides

  9. SEISMIC Trial: Efficacy Endpoint at 6 months 54.5±7.1mm End Systolic LV diameter (mm) 39.4±2.7mm Copyleft Clinical Trial Results. You Must Redistribute Slides Presented at SCAI/ACC i2 08 Summit

  10. SEISMIC Trial: Limitations • Future trials may consider including a larger sample size to appropriately power the study. Presented at SCAI/ACC i2 08 Summit

  11. SEISMIC Trial: Summary • Autologous myoblast implantation in patients with congestive heart failure is feasible. • Myoblast implantation may improve symptoms of heart failure. • There was no significant effect in ventricular thickness or LV ejection fraction between the cell therapy group and the medical treatment group at 6 months. Presented at SCAI/ACC i2 08 Summit