Transcatheter Transplantation of Autologous Skeletal Myoblasts in Postinfarction Patients with Severe Left Ventricular Dysfunction

Abstract

Purpose:

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 (210times10⁶±150times10⁶ 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.