Myocardial Repair by Percutaneous Cell Transplantation of Autologous

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% 30% 25% 20% 15% 10% 5% 0% 34.4% 36.6% • 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 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 250 200 238 219 End systolic volume p=0.56 158 mL 150 100 50 0 143 • There was no difference in change from baseline to 12 months in end diastolic and end systolic volumes 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 Wall Motion Score Index At rest p=0.049 3.5 3.0 2.5 2.0 1.5 1.0 0.5 0.0 At low-dose dobutamine stress p=0.07 3.04 2.75 2.77 2.46 • 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 Baseline 12 months Presented at ACC Scientific Sessions 2005 www. Clinical trial results.org 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