Transcript SEISMIC Trial - Clinical Trial Results

SEISMIC Trial
The Safety and Effects of
Implanted (Autologous) Skeletal
Myoblasts (MyoCell) using an
Injection Catheter Trial
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SEISMIC Trial
SEISMIC Trial
Presented at ACC / i2 2008 in Chicago
Presented by Dr. Patrick W. Serruys
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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 preclinical 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.
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Presented at SCAI/ACC i2 08 Summit
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.
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SEISMIC Trial: Primary Safety Endpoint
Incidence of adverse
events
20
• There were 15
incidences of sustained
arrhythmia in the cell
therapy group vs. 14
incidences in the medical
treatment control group.
15
14
Cell therapy
Medical treatment
15
10
5
0
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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.
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SEISMIC Trial: Efficacy Endpoint cont.
30%
50%
41.7%
20%
10%
17.6%
8.3%
n =1
NYHA HF status
deterioration (%)
NYHA HF status
improvement (%)
40%
30%
20%
10%
5.9%
n =5
n =3
n =1
0%
0%
Medical
treatment
Cell
therapy
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Medical
Cell
treatment therapy
Presented at SCAI-ACC i2 Summit
Global EF (%)
SEISMIC Trial: Efficacy Endpoint at 6 months
40%
35%
30%
25%
20%
15%
10%
5%
0%
• Global ejection fraction
was higher in the medical
treatment group
compared to the cell
therapy group after 6
month follow-up.
32.9%
29.2%
Medical treatment
Cell therapy
Presented at SCAI-ACC i2 08 Summit
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End Systolic LV
diameter (mm)
SEISMIC Trial: Efficacy Endpoint at 6 months
65.0
60.0
55.0
50.0
45.0
40.0
35.0
30.0
25.0
20.0
15.0
10.0
5.0
0.0
54.5
39.4
54.5±7.1mm
39.4±2.7mm
Medical treatment
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Cell therapy
Presented at SCAI/ACC i2 08 Summit
SEISMIC Trial: Limitations
• Future trials may consider including a
larger sample size to appropriately power
the study.
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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.
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Presented at SCAI/ACC i2 08 Summit