title: Safety and feasibility of autologous myoblast transplantation in patients with ischemic cardiomyopathy: four-year follow-up.
abstract: BACKGROUND
  Successful autologous skeletal myoblast transplantation into infarcted myocardium in a variety of animal models has demonstrated improvement in cardiac function. We evaluated the safety and feasibility of transplanting autologous myoblasts into infarcted myocardium of patients undergoing concurrent coronary artery bypass grafting (CABG) or left ventricular assist device (LVAD) implantation. In addition, we sought to gain preliminary information on graft survival and any associated changes in cardiac function.
  
  
  RESULTS
  Thirty patients with a history of ischemic cardiomyopathy participated in a phase I, nonrandomized, multicenter pilot study of autologous skeletal myoblast transplantation concurrent with CABG or LVAD implantation. Twenty-four patients with a history of previous myocardial infarction and a left ventricular ejection fraction <40% were enrolled in the CABG arm. In a second arm, 6 patients underwent LVAD implantation as a bridge to heart transplantation, and patients donated their explanted native hearts for testing at the time of heart transplantation. Myoblasts were successfully transplanted in all patients without any acute injection-related complications or significant long-term, unexpected adverse events. Follow-up positron emission tomography scans showed new areas of glucose uptake within the infarct scar in CABG patients. Echocardiography measured an average change in left ventricular ejection fraction from 28% to 35% at 1 year and of 36% at 2 years. Histological evaluation in 4 of 6 patients who underwent heart transplantation documented survival and engraftment of the skeletal myoblasts within the infarcted myocardium.
  
  
  CONCLUSIONS
  These results demonstrate the survival, feasibility, and safety of autologous myoblast transplantation and suggest that this modality offers a potential therapeutic treatment for end-stage heart disease.
authors.affiliation: Arizona Heart Institute, Phoenix, AZ 85006, USA. Ndib@azheart.com
authors.forename: Nabil
authors.initials: N
authors.lastname: Dib
authors.forename: Robert E
authors.initials: RE
authors.lastname: Michler
authors.forename: Francis D
authors.initials: FD
authors.lastname: Pagani
authors.forename: Susan
authors.initials: S
authors.lastname: Wright
authors.forename: Dean J
authors.initials: DJ
authors.lastname: Kereiakes
authors.forename: Rose
authors.initials: R
authors.lastname: Lengerich
authors.forename: Philip
authors.initials: P
authors.lastname: Binkley
authors.forename: Diane
authors.initials: D
authors.lastname: Buchele
authors.forename: Inder
authors.initials: I
authors.lastname: Anand
authors.forename: Cory
authors.initials: C
authors.lastname: Swingen
authors.forename: Marcelo F
authors.initials: MF
authors.lastname: Di Carli
authors.forename: James D
authors.initials: JD
authors.lastname: Thomas
authors.forename: Wael A
authors.initials: WA
authors.lastname: Jaber
authors.forename: Shaun R
authors.initials: SR
authors.lastname: Opie
authors.forename: Ann
authors.initials: A
authors.lastname: Campbell
authors.forename: Patrick
authors.initials: P
authors.lastname: McCarthy
authors.forename: Michael
authors.initials: M
authors.lastname: Yeager
authors.forename: Vasken
authors.initials: V
authors.lastname: Dilsizian
authors.forename: Bartley P
authors.initials: BP
authors.lastname: Griffith
authors.forename: Ronald
authors.initials: R
authors.lastname: Korn
authors.forename: Steven K
authors.initials: SK
authors.lastname: Kreuger
authors.forename: Marwan
authors.initials: M
authors.lastname: Ghazoul
authors.forename: W Robb
authors.initials: WR
authors.lastname: MacLellan
authors.forename: Gregg
authors.initials: G
authors.lastname: Fonarow
authors.forename: Howard J
authors.initials: HJ
authors.lastname: Eisen
authors.forename: Jonathan
authors.initials: J
authors.lastname: Dinsmore
authors.forename: Edward
authors.initials: E
authors.lastname: Diethrich
mesh_terms: D000328:Adult; D000368:Aged; D002125:Calcium Gluconate; D009202:Cardiomyopathies / Q000401:mortality / Q000601:surgery*; D004452:Echocardiography; D019560:Echocardiography, Three-Dimensional; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D032446:Myoblasts / Q000637:transplantation*; D017202:Myocardial Ischemia / Q000628:therapy; D012449:Safety; D016019:Survival Analysis; D014182:Transplantation, Autologous / Q000009:adverse effects / Q000401:mortality; D016277:Ventricular Function, Left
chemical_list: D002125:Calcium Gluconate