Transcript Myocardial Repair by Percutaneous Cell Transplantation of

Myocardial Repair by Percutaneous Cell Transplantation
of Autologous Skeletal Myoblast as a Stand Alone
Procedure in Post MI CHF Patients – 12 months
Myocardial Repair by Percutaneous Cell
Transplantation of Autologous Skeletal Myoblast as a
Stand Alone Procedure in Post Myocardial Infarction
Chronic Heart Failure Patients
Presented at
American College of Cardiology
Scientific Sessions 2005
Presented by Dr. Patrick W. Serruys
Myocardial Repair by Percutaneous Cell Transplantation
of Autologous Skeletal Myoblast as a Stand Alone
Procedure in Post MI CHF Patients – 12 months
15 symptomatic heart failure patients with New York Heart Association class ≥2,
previous anterior wall MI ≥4 weeks at time of transplantation, LV ejection
fraction 20-45%, no contractile reserve during dobutamine stress echo**
Mean age 63 years. 7% female. Mean baseline ejection fraction 29%.
All patients underwent percutaneous transendocardial skeletal myoblast
injection as a stand alone procedure using NOA or fluoroscopy guided
injection catheter. †
Endpoints (median follow-up 1 year):

Ejection Fraction, end diastolic volume, end systolic volume, wall motion score index
** the first 6 patients enrolled in the study did not have an implantable cardiac defibrillator (ICD), as this was initially an exclusion criteria. Among
those 6 initial patients, 3 patients had an event, one ventricular tachycardia, one non-sustained ventricular tachycardia, and one death. As a result,
the study was modified to require ICD implantation as inclusion criteria.
† an average of 18 injections were performed on each patient with 15 million cells per injection. Patients were monitored with Holter, ECG tests,
stress echocardiography and LV angiography.
www. Clinical trial results.org
Presented at ACC Scientific Sessions 2005
Myocardial Repair by Percutaneous Cell Transplantation
of Autologous Skeletal Myoblast as a Stand Alone
Procedure in Post MI CHF Patients – 12 months
Ejection Fraction
p=0.26
40%
35%
36.6%
34.4%
30%
25%
20%
15%
10%
• Mean baseline ejection fraction
was 29%, and 87% were treated
with ACE-inhibitors. An average
of 215 million cells were injected,
with cell viability of 96%. The
mean time post-MI was 6 years
• There was no difference in
change from baseline to 12
months in ejection fraction
5%
0%
Baseline
12 months
www. Clinical trial results.org
Presented at ACC Scientific Sessions 2005
Myocardial Repair by Percutaneous Cell Transplantation
of Autologous Skeletal Myoblast as a Stand Alone
Procedure in Post MI CHF Patients – 12 months
End diastolic
volume
250
238
219
End systolic
volume
p=0.56
200
mL
158
150
143
100
• There was no difference in change
from baseline to 12 months in end
diastolic and end systolic volumes
50
0
Baseline
www. Clinical trial results.org
12 months
Presented at ACC Scientific Sessions 2005
Myocardial Repair by Percutaneous Cell Transplantation
of Autologous Skeletal Myoblast as a Stand Alone
Procedure in Post MI CHF Patients – 12 months
Wall Motion Score Index
At low-dose
dobutamine
stress
At rest
p=0.049
3.5
3.0
p=0.07
3.04
2.77
2.75
2.46
2.5
2.0
1.5
1.0
• Wall motion score index was
lower at follow-up compared
with baseline both at rest and
at low-dose dobutamine stress
• New York Heart Association
class improved from 2.8 at
baseline to 1.8 at one year
0.5
0.0
Baseline
12 months
www. Clinical trial results.org
Presented at ACC Scientific Sessions 2005
Myocardial Repair by Percutaneous Cell Transplantation
of Autologous Skeletal Myoblast as a Stand Alone
Procedure in Post MI CHF Patients – 12 months
• Among post myocardial infarction chronic heart failure patients,
percutaneous cell transplantation of autologous skeletal
myoblast as a stand alone procedure was feasible but was
associated with a large number of ventricular arrhythmias. Eight
of the 15 patients in the trial had some type of ventricular
disturbance.
• There were improvements in wall motion and NYHA class
suggesting potential efficacy, but the safety of the procedure is
unclear. These safety results differ somewhat from the
POZNAN study, where only one of the nine patients had an
arrhythmia. The overall number of patients enrolled in both
studies is small.
www. Clinical trial results.org
Presented at ACC Scientific Sessions 2005