Transcatheter transplantation of autologous skeletal myoblasts in postinfarction patients with severe left ventricular dysfunction.
OBJECTIVE
To report a case-controlled safety and feasibility study of transcatheter transplantation of autologous skeletal myoblasts as a stand-alone procedure in patients with ischemic heart failure.


METHODS
Six men (mean age 66.2+/-7.2 years) were eligible for transcatheter transplantation of autologous skeletal myoblasts cultured from quadriceps muscle biopsies. Six other men (mean age 65.7+/-6.3 years) were selected as matched controls (no muscle biopsies). A specially designed injection catheter was advanced through a femoral sheath into the left ventricle cavity, where myoblasts in solution (0.2 mL/injection) were injected into the myocardium via a 25-G needle. At baseline and in follow-up, both groups underwent Holter monitoring, a 6-minute walk test, New York Heart Association (NYHA) class determination, and echocardiography with dobutamine challenge.


RESULTS
Skeletal myoblast transplantation was technically successful in all 6 patients with no complications; 19+/-10 injections were performed per patient (210 x 10(6)+/-150 x 10(6) cells implanted per patient). Left ventricular ejection fraction (LVEF) rose from 24.3%+/-6.7% at baseline to 32.2%+/-10.2% at 12 months after myoblast implantation (p=0.02 versus baseline and p<0.05 versus controls); in matched controls, LVEF decreased from 24.7%+/-4.6% to 21.0%+/-4.0% (p=NS). Walking distance and NYHA functional class were significantly improved at 1 year (p=0.02 and p=0.001 versus baseline, respectively), whereas matched controls were unchanged.


CONCLUSIONS
Transcatheter transplantation of autologous skeletal myoblasts for severe left ventricular dysfunction in postinfarction patients is feasible, safe, and promising. Scrutiny with randomized, double-blinded, multicenter trials appears warranted.
Ince
Hüseyin
H
Division of Cardiology/Angiology and Department of Internal Medicine at the University Hospital Rostock, Germany.
Petzsch
Michael
M
Rehders
Tim C
TC
Chatterjee
Tushar
T
Nienaber
Christoph A
CA
D000368:Aged; D006328:Cardiac Catheterization; D016022:Case-Control Studies; D017690:Cell Transplantation / Q000379:methods; D016009:Chi-Square Distribution; D017023:Coronary Angiography; D005240:Feasibility Studies; D005500:Follow-Up Studies; D006084:Graft Rejection; D006085:Graft Survival; D006801:Humans; D008297:Male; D008875:Middle Aged; D032446:Myoblasts / Q000637:transplantation*; D009203:Myocardial Infarction / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D011336:Probability; D018570:Risk Assessment; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000150:complications / Q000175:diagnosis / Q000628:therapy*